Compact Clinical Guide to Women's Pain Management: An Evidence-Based Approach for Nurses [1 ed.] 9780826193865, 9780826193858

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Compact Clinical Guide to Women’s Pain Management

COMPACT CLINICAL GUIDE TO

An Evidence-Based Approach for Nurses “Unfortunately, the care provided to women in pain often adds to the suffering rather than relieving it. This clinical resource describes the evidence-based approach to women’s pain that offers optimum relief as well as a compassionate response. . . . Congratulations to Yvonne for the creation of this resource, which will serve as an excellent tool for clinicians dedicated to pain relief for women.” —Betty Ferrell, PhD, MA, FAAN, FPCN, CHPN Professor and Research Scientist, City of Hope, Duarte, California

C

oncise and portable, this is the only clinical reference to address the management of all commonly presented pain conditions particular to women—both physiological and psychological. It is written by an NP pain management specialist for nurses in all settings, and provides evidence-based guidelines for treating women’s pain as a unique entity. The guide provides quick access to nursing guidelines for treatment of fibromyalgia pain, TMJ pain, phantom breast pain, postmastectomy pain syndrome, menstrually related migraine headaches, irritable bowel syndrome pain, interstitial cystitis pain, and STD-related and pelvic pains. Pharmacologic and nonpharmacologic treatment options, current information from national guidelines (including using a combination of pain management scales for optimal pain assessment and management), along with regional anesthesia techniques, patient-controlled analgesia, and epidural pain management, are also included. Also addressed is the role of estrogen in female pain response. Options for managing extreme pain situations, how to screen and treat potential substance abusers, and the physiologic bases of gender-different pain responses are additionally covered. Each chapter features a Questions to Consider section that focuses on interventions and techniques to improve outcomes. Of particular note is a section on managing pain in obese women who suffer from pelvic pain syndromes and fibromyalgia, among other types of pain.

KEY FEATURES: • Discusses pharmacologic and complementary pain management • Addresses physiologic bases of gender-different pain responses • Provides cutting-edge information regarding pain in obese women and managing extreme pain situations • Offers new information on opioid polymorphisms that helps explain why pain medication is sometimes less effective than expected ISBN 978-0-8261-9385-8

11 W. 42nd Street New York, NY 10036-8002 www.springerpub.com

9 780826 193858

Women’s Pain Management

Yvonne D’Arcy, MS, CRNP, CNS

D’ARCY

Compact Clinical Guide to

Women’s Pain Management YVONNE D’ARCY AN EVIDENCE-BASED APPROACH FOR NURSES

THE COMPACT CLINICAL GUIDE SERIES Series Editor Yvonne D’Arcy, MS, CRNP, CNS Compact Clinical Guide to CHRONIC PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Yvonne D’Arcy, MS, CRNP, CNS Compact Clinical Guide to ACUTE PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Yvonne D’Arcy, MS, CRNP, CNS Compact Clinical Guide to CRITICAL CARE, TRAUMA, AND EMERGENCY PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Liza Marmo, MSN, RN-BC, CCRN, and Yvonne D’Arcy, MS, CRNP, CNS Compact Clinical Guide to GERIATRIC PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Ann Quinlan-Colwell, PhD, RNC, AHNBC, FAAPM Compact Clinical Guide to INFANT AND CHILD PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Linda L. Oakes, MSN, RN-BC, CCNS Compact Clinical Guide to CANCER PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Pamela Stitzlein Davies, MS, ARNP, ACHPN, and Yvonne D’Arcy, MS, CRNP, CNS Compact Clinical Guide to WOMEN’S PAIN MANAGEMENT: An Evidence-Based Approach for Nurses Yvonne D’Arcy, MS, CRNP, CNS

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Compact Clinical Guide to WOMEN’S PAIN MANAGEMENT

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Yvonne D’Arcy, MS, CRNP, CNS, is a nurse practitioner for pain management and palliative care at Suburban Hospital–Johns Hopkins Medicine, Bethesda, MD. She has significant experience in pain management, having worked as the pain management nurse practitioner and staff education coordinator at Johns Hopkins Oncology Center, acute pain service coordinator and pain clinic supervisor at the Mayo Clinic, Jacksonville, FL, and pain center manager and clinical coordinator of the Acute Pain Service at the Heartland Health System, St. Joseph, MO. Her accomplishments include delivering more than 100 poster and oral presentations; publishing more than 100 journal articles on pain-related topics; authoring 10 books on pain; serving as consultant for pharmaceutical companies, Department of Veterans Affairs hospitals, pain clinics, and publishing companies; and serving on the editorial boards of  Nursing, Journal for Nurse Practitioners, and Pain Management News. Ms. D’Arcy has been an active member of the American Pain Management Society and the American Society for Pain Management Nursing, having served on various committees and task forces and in executive positions. She is the winner of the Nursing Spectrum Excellence award for advancing and leading the profession for the Mid-Atlantic region and her book How to Manage Pain in the Elderly is the winner of the American Journal of Nursing Book of the Year award. She presents frequently on a variety of pain management topics, including neuropathic pain, chronic pain, pain in the elderly, women’s pain, and pain in the obese patient.

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Compact Clinical Guide to WOMEN’S PAIN MANAGEMENT An Evidence-Based Approach for Nurses

Yvonne D’Arcy, MS, CRNP, CNS

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Copyright © 2014 Springer Publishing Company, LLC All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Springer Publishing Company, LLC, or authorization through payment of the appropriate fees to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400, fax 978-646-8600, [email protected] or on the Web at www.copyright.com. Springer Publishing Company, LLC 11 West 42nd Street New York, NY 10036 www.springerpub.com Acquisitions Editor: Margaret Zuccarini Composition: S4Carlisle Publishing Services ISBN: 978-0-8261-9385-8 e-book ISBN: 978-0-8261-9386-5 13 14 15 16 17 / 5 4 3 2 1 The author and the publisher of this Work have made every effort to use sources believed to be reliable to provide information that is accurate and compatible with the standards generally accepted at the time of publication. Because medical science is continually advancing, our knowledge base continues to expand. Therefore, as new information becomes available, changes in procedures and drug indications and dosages become necessary. We recommend that the reader always consult current research, current drug formularies, and specific institutional policies before performing any clinical procedure or administering or prescribing any drug. The author and publisher shall not be liable for any special, consequential, or exemplary damages resulting, in whole or in part, from the readers’ use of, or reliance on, the information contained in this book. The publisher has no responsibility for the persistence or accuracy of URLs for external or third-party Internet websites referred to in this publication and does not guarantee that any content on such websites is, or will remain, accurate or appropriate. Library of Congress Cataloging-in-Publication Data D’Arcy, Yvonne M., author. Compact clinical guide to women’s pain management : an evidence-based approach for nurses / Yvonne M. D’Arcy. p. ; cm. — (Compact clinical guide) Includes bibliographical references and index. ISBN 978-0-8261-9385-8—ISBN 0-8261-9385-4—ISBN 978-0-8261-9386-5 (ebook) I. Title. II. Series: Compact clinical guide series. [DNLM: 1. Pain Management—methods. 2. Evidence-Based Nursing. 3. Pain—drug therapy. 4. Women. WY 160.5] RB127 616’.0472—dc23 2013021406 Special discounts on bulk quantities of our books are available to corporations, professional associations, pharmaceutical companies, health care organizations, and other qualifying groups. If you are interested in a custom book, including chapters from more than one of our titles, we can provide that service as well. For details, please contact: Special Sales Department, Springer Publishing Company, LLC 11 West 42nd Street, 15th Floor, New York, NY  10036-8002 Phone:  877-687-7476 or 212-431-4370; Fax:  212-941-7842 E-mail:  [email protected] Printed in the United States of America by Gasch Printing.

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I dedicate this book to all women who have experienced unrelieved pain. Women who looked for help and did not find any. Women who have been told their pain was in their heads, not real. Women whose pain has been minimalized and dismissed. Women who have been told they should stop talking about their pain. I hope this book will give you renewed confidence that there are answers about the causes of your pain and you deserve them. I also dedicate this book to my mother, Mary D’Arcy, and my grandmother, Stephanie Hermanek, who came to this country with nothing but hope. These women are my roots from where I get my strength and perseverance. To my daughters, Lauren Burns and Leslee Cronin, and my granddaughters Jacqueline Cronin, Sophia Burns, and Gabriella Burns, who are the recipients of my legacy and who will, in turn, bloom and find their own mission in life.

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Contents

Foreword by Betty Ferrell, PhD, MA, FAAN, FPCN, CHPN Preface

xi

xiii

SECTION I: OVERVIEW OF PAIN IN WOMEN 1. The Problem of Pain in Women

1

2. The Art and Science of Pain Assessment

17

SECTION II: COMMON MEDICATIONS AND TREATMENT OPTIONS FOR PAIN MANAGEMENT 3. Nonopioid Medications 4. Opioid Medications

45 63

5. Coanalgesic Medications

87

6. Complementary and Alternative Medicine Techniques for Managing Pain 99 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia 117 SECTION III: INTERVENTIONAL OPTIONS FOR MANAGING ACUTE/CHRONIC PAIN 8. Regional Techniques 9. Implanted Techniques

139 149

10. Labor and Delivery Pain Management Options

159 ix

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Contents

SECTION IV: SPECIAL TREATMENT CONSIDERATIONS 11. Effect of Opioid Polymorphisms

167

12. Differences in Opioid Addiction, Dependency, and Tolerance 187 13. Developing a Comprehensive Treatment Plan

201

SECTION V: MANAGING COMMON PAIN CONDITIONS THAT AFFECT WOMEN 14. Headaches and Menstrually Related Migraines 15. Fibromyalgia

211

221

SECTION VI: NEUROPATHIC PAIN SYNDROMES 16. Neuropathic Pain Conditions and Postmastectomy and Phantom Breast Pain 231 17. Chronic Pelvic Pain, Endometriosis, Vulvodynia, and Dyspareunia 255 18. Interstitial Cystitis

265

19. Irritable Bowel Syndrome

273

20. Temporomandibular Pain

281

21. STDs, Herpes, Chlamydia, HIV/AIDS

289

22. Women’s Athletic Pain Conditions, Runner’s Knee 23. The Obese Woman and Pain

299

307

Appendices A. Women’s Pain: Helpful Websites 319 B. Equianalgesic Conversion Table 321 Index

325

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Foreword

The topic of women’s pain is seriously neglected and women are an example of one of the most vulnerable patient groups experiencing pain. Women in pain often experience complex pain syndromes, struggle to be believed, and face issues of power imbalance, lack of understanding of women’s health needs, and treatment approaches inadequate for the significant pain experienced. Pain syndromes in women such as fibromyalgia, migraines, interstitial cystitis, and irritable bowel syndrome are, unfortunately, often not believed, not thoroughly assessed, and systematically undertreated. Unfortunately, the care provided to women in pain often adds to the suffering rather than relieving it. This clinical resource describes the evidencebased approach to women’s pain that offers optimum relief as well as a compassionate response. This book is written by Yvonne D’Arcy, a true leader, educator, clinician, and advocate for pain relief for all vulnerable populations. I met Yvonne in 1991 and was, and remain, very impressed by her passionate commitment to pain relief. For Yvonne, pain management is not just a clinical area of practice; it is a calling. I have witnessed her passion and compassion and her excellence in education and practice. Only once over these 20-plus years did I witness a slight break in Yvonne’s passion and commitment. It occurred when Yvonne, a nurse from the northern United States, attended our pain resource nurse training in California and had the unfortunate timing of being here for an earthquake. I still recall Yvonne’s change in enthusiasm as the earth shook beneath her. A few years later Yvonne invited Margo McCaffery and me to the launch of her long-planned Pain Resource Nurse Training Course in upper Wisconsin. We arrived in the midst of a horrendous blizzard. After what truly was a travel nightmare, we were able to arrive in the early morning, just hours before the course began. Waiting at the hotel desk was a note for us from Yvonne that read, “Got you back. Welcome to Wisconsin.”

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Foreword

Congratulations to Yvonne for creation of this resource, which will serve as an excellent tool for clinicians dedicated to pain relief for women. Women deserve respectful, evidence-based care and relief from pain that destroys quality of life, if undetected by the clinician and left untreated. That care begins with educated and empowered clinicians who can advocate for such care. Betty Ferrell, PhD, MA, FAAN, FPCN, CHPN Professor and Research Scientist City of Hope, Duarte, California

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Preface

This book is something that I dreamed of writing for many years. Some might say, “Why write a book about women’s pain, isn’t all pain the same?” My answer would have to be no, there are differences that make women’s pain unique and therein lies the crux of the problem. Only someone who has experienced pain as a woman would be able to see that the differences are there. These very real differences affect outcomes and quality of life and reach down to the basic essentials of everyday life, such as being able to support yourself or care for children. It’s been my mission to provide information about why pain is different in women, which makes treating it more complex; differences that I knew were there but could not always convey or explain. My own experience with women’s pain began in December of 1991 when I fell on my driveway in 30-below wind-chill temperature on a cold and snowy day in Wisconsin. When I looked down I could see that there was something dramatically wrong with my left leg. My knee was pointing up and my lower leg was pointing sideways. Being a good neurosurgery nurse, I flexed my toes and could still feel everything. That falsely reassured me that all was well. Still, being a little shocked to be in this situation, as I was loaded into the ambulance I deferred getting any pain medication until I was in the emergency department, where the pain of the multiple fractures began to make itself an entity that was going to be a part of my life from that day forward. I could never have anticipated how that simple misstep would change the quality of my life. Over the weeks, months, and years, I have had surgery and physical therapy, and been told by well-meaning health care providers who really did not understand what I was trying to tell them, that I should stop looking for a way to treat my pain and “just live with it.” They just could not seem to get their heads around the idea that I really wanted to have good pain control and go back to work. They felt that if I could work, my pain was well controlled. Little did they understand how much it took for me to get to work and be able to work a shift. My physician colleagues would see xiii

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Preface

I was in pain and tell me to come see them, but they had no answers. Other coworkers could see I was in pain and became somewhat immune as time went by. I remember the look on the physician’s face when he informed me that he did not treat chronic pain. Because it was now over 3 months and I still had pain, I needed to be seen by a physical medicine specialist. The specialist’s response was to take heavy nonsteroidals and get physical therapy, because since I was able to work I certainly “could not be having that much pain.” I went looking for answers to “Why me?” “Why so much pain?” “What was causing the pain?” and no one had any answers that could help me. At a nursing conference, Margo McCaffery told me if no one could help me with my pain, then she could. It was the first time even a brief ray of hope existed. She empowered me to take control of my pain treatment; to look for doctors who believed that I had pain, who would not dismiss my complaints and needs, and would not condemn me to a life of heavy reliance on nonsteroidal anti-inflammatory drugs (NSAIDs). They say that all things have a reason for being. I believe my experience led me to a new career in pain management. I have worked in the field for 20 years and have seen women have the same experience that I had; women whose pain was minimalized and dismissed as emotional or psychiatric, women who suffered from poorly understood conditions, such as fibromyalgia, where treatment options were limited. I remember the hopeful look on one patient’s face when I told her I believed she had pain. She had come into the hospital complaining of severe neck pain but had had no luck over the past 6 months in finding a cause or reason for her pain, leading those around her to think she did not have the pain she was describing. She was tearful and looked so defeated. After a comprehensive workup the doctors did discover a source of pain easily treated with a simple surgery that made her completely pain free. She thanked me profusely as she left the hospital with a new hopeful outlook. She told me she appreciated my belief in her pain and that my support helped her through the arduous diagnostic process. I hope this book presents the helpful information that I wish I had been able to find when I first evaluated women’s pain and why it was different from that in men. I am so pleased that researchers are developing protocols to assess the basis for the sex and gender differences in pain and coming to some clinically applicable conclusions. I am always excited to attend lectures that these days have a base in the genetics and polymorphisms of pain, where differences in pain response are correctly attributed to variations in physiology. Women’s pain is different from men’s;

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Preface

xv

we have some disparate physiologic processes, and we respond differently to pain medications. Sex and gender differences and genetic variations in pain are the new frontiers of pain management. In the future, I hope that pain treatments will be individualized to each person’s needs rather than a “one-size-fitsall” approach. I have strong faith that women will see great advances in how their pain is perceived and treated. To my readers, I hope you take this information into your practices and work to make adequate analgesia a reality for all women. Yvonne D’Arcy, MS, CRNP, CNS

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SECTION I: OVERVIEW OF PAIN IN WOMEN

1 The Problem of Pain in Women

For many years the idea of differences in the pain of men and women was not a topic that was discussed in professional circles, let alone considered as a focus for research studies. It was assumed that pain was pain, and that women reacted to a pain stimulus differently with a more emotional response. It was commonly accepted that women had a higher prevalence of pain, but the mechanisms that created the difference were not well understood (Fillingim, 2010; LeResche, 2011). It was postulated that since women sought help from health care providers more frequently, they would naturally seem to have more pain complaints. No one even considered that women might respond to pain or pain medications differently than men. When researchers looked at what might be different in sex-related response to pain, any differences in physiologic response were explained by the variation in monthly estrogen levels in women. As such, women were not considered to be good research subjects, and even in a condition typically affecting women such as breast cancer, many of the early studies were done using only men as study participants. After studying pain differences in women, findings indicated that women had a two- to six-fold higher prevalence of persistent painful conditions that produce higher intensities of pain (Greenspan et al., 2007). In the mid-1990s, publications started appearing in reputable journals, highlighting the need to study the pain response of women and determine if there was a difference that made women’s pain a unique experience for them. In a review of studies published in PAIN, the journal of the International Association for the Study of Pain (IASP), between 1996 and 2005, 79% of the animal studies observed male subjects only, with only 4% reporting data from both sexes (Mogil, 2009). The findings of these male-exclusive studies began to call into question the validity and generalizability of the results. The scientific community began to

1

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2 1. The Problem of Pain in Women understand that using a narrow window for research, such as the use of all-male subjects, might have created bias and skewed the results of numerous research studies, making them less generalizable to the population as a whole. At the same time, the National Institutes of Health (NIH) developed several initiatives on pain in women that generated significant interest in the topic. In 1994 the NIH mandated that all clinical trials with NIH support include a representative sample of female participants (Hurley & Adams, 2008). After this initiative, researchers began to explore the various areas of pain in women. They tried to determine if there was an overall difference in pain in women, or if there was only a difference in some of the pain syndromes that were more common in women than in men, such as fibromyalgia and osteoarthritis pain. In 2006 the IASP Sex, Gender, and Pain Special Interest Group (SIG) developed a consensus document on the differences between sexes in pain and analgesia (Greenspan et al., 2007). This document presents best practice data that can be used to develop and expand the role of research using female participants. One of the basic recommendations to researchers was that they include both sexes in their research. If limited by practical considerations, then using only female subjects was recommended (Greenspan et al., 2007). Additionally, the consensus document indicates that sex-related differences in pain change over time as female subjects mature and estrogen levels fall. The IASP also declared 2007 as the Global Year Against Pain in Women. Funded by the IASP, the entire year’s initiatives focused on the effect of pain in women. One of the most important fi ndings of this new research was that women do, in fact, experience more pain than men (Collett & Berkley, 2007) and found that there are any number of physiologic and psychological differences in pain response in women. Pain in women not only affects individual families but also affects work productivity and health benefits and creates low incomes (Collett & Berkley, 2007). Th is is an area that truly deserves more research to fully understand the impact of pain in women; not only for women themselves, but for society as a whole as well. The research and related guidelines for women’s pain are not as developed as those for patients with more common pain conditions such as chronic pain. However, with the support of the NIH initiatives and more national and international exposure, the focus on women’s pain has increased. There is also much more interest in determining the differences in the two sexes when pain is involved, and in learning about how women process pain and respond to medications.

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Prevalence of Women’s Pain Syndromes

3

GENDER AND SEX There is a difference between the terms gender and sex. They are not interchangeable. Sex is defined as “the classification of living things, generally as male or female according to their reproductive organs and function assigned by the chromosomal complement” (Hurley & Adams, 2008). Gender is defined as “a person’s self-representation as male or female, or how society reacts to that person on the basis of the individual’s gender presentation” (Hurley & Adams, 2008). Sex, by definition, is considered to be more related to the physical differences between men and women. Gender, on the other hand, has more psychological, environmental, and sociological effects, including society’s acceptance of a person presenting as a man or woman (Greenspan et al., 2007; Racine et al., 2012a).

PREVALENCE OF WOMEN’S PAIN SYNDROMES There are some basic differences between pain in women versus pain in men, with some pain syndromes more prevalent in women. In general, women: ■ Report pain that is more severe in intensity ■ Have more frequent episodes of pain ■ Have pain that is more diff use and longer lasting than males with the same condition ■ Have pain that is more frequently visceral or musculoskeletal in origin ■ Experience more pain related to autoimmune disorders (Hurley & Adams, 2008) ■ Have a higher incidence of pain catastrophizing (Greenspan, Craft, & LeResche, 2007) What types of painful conditions are more prevalent in women than men? Overall, women seem to have higher odds of developing chronic pain conditions (Fillingim & Gear, 2004). General findings from chronic pain studies indicate that women have higher intensities of pain, more frequent pain, higher levels of pain-related negative effects, and higher pain-related levels of disability than men (Filligim, 2010). Although some conditions such as osteoarthritis affect both men and women, some conditions have more females than males in the patient groups. The conditions that affect more females than males include: ■ Autoimmune diseases: rheumatoid arthritis, lupus erythematosus, and multiple sclerosis ■ Diseases of visceral origin: chronic constipation, irritable bowel syndrome, proctalgia fugax, esophagitis pain, and postcholecystectomy pain

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4 1. The Problem of Pain in Women ■

■

Extremity pain: carpal tunnel syndrome, Raynaud’s disease, complex regional pain syndrome (CRPS) type I, scleroderma, chronic venous insufficiency, peroneal muscle atrophy, and piriformis syndrome Types of head pain: chronic tension headache, migraine with aura, postdural puncture headache, cervicogenic headache, temporal arteritis, occipital neuralgia, odontalgia, burning mouth, trigeminal neuralgia, temporomandibular disorder (TMJ) (Hurley & Adams, 2007)

OTHER PHYSIOLOGIC DIFFERENCES IN PAIN BETWEEN MEN AND WOMEN Is there a difference in pain threshold, tolerance, and response to experimental versus clinical pain between men and women? The preliminary data on sex-related differences in the pain experience were first generated by experimental rodent studies and later moved to human research. It is very difficult to export findings to clinical pain management when using animal- and laboratory-invoked pain stimuli. Many of the early studies used experimental pain stimuli such as thermal or pressure pain rather than clinical presentations. In the rodent studies, findings indicated that female rodents had a lower pain threshold when the research involved hot thermal, chemical, inflammatory, and mechanical pain stimuli (Hurley & Adams, 2008). The results for response to type of pain, neuropathic or visceral, had inconsistent findings. Overall, a review study indicated that female rodents were more sensitive to noxious stimuli than male rodents, and females had lower levels of endogenous analgesia (Mogil & Chanda, 2005). These rodent studies also eliminate the confounding variables of societal, environmental, and psychological influences that humans experience. Pain studies in humans present different challenges. The subjects are able to verbalize pain, but creating a pain stimulus for research purposes alone creates an ethical question. Additionally, the results of an experimental pain stimulus are not easy to transfer to a clinical practice. In experimental studies using human subjects less than 60 years of age and deemed as healthy, female participants reported higher pain severity at

Clinical Pearl

Pain threshold: Ability of the nervous system to fi rst iden fy a sensa on as pain. Pain tolerance: Amount of pain that the person will tolerate.

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Medication Response Differences

5

lower thresholds. Females also had less tolerance for noxious stimuli than males, with differences being seen when mechanical pain or pressure pain was used (Hurley & Adams, 2008). When observing patients with pain induced by immersion in a hot water bath, correlation of increased heart rate to pain was present in men but not women (Tousignant-Laflamme, Rainville, & Marchand, 2005). Conversely, when cold was used as a pain stimulus, females tolerated less pain than male subjects, while data indicated little difference in pain threshold (Racine et al., 2012a). In a review of 122 studies, results seem to indicate that females and males have comparable detection thresholds for cold and ischemic pain, while females tolerate less pressure and thermal pain (Racine et al., 2012a). Since the research on male versus female pain is scant and based on experimental pain, it is hard to make firm conclusions. Most of the current research has been done in animal models or with healthy subjects, and some studies have very small sample sizes given the type of research being done. Hopefully, as the science progresses, clinical studies in patients with painful conditions can yield more applicable data that can be used for patient care.

MEDICATION RESPONSE DIFFERENCES The potency of opioids varies according to sex affected by different types of opioid receptor agonists, mu or kappa, and gonadal hormone levels (Dahan, Kest, Waxman, et al., 2008). Overall, males tend to have a better analgesic response to mu binding opioids such as morphine. Women, on the other hand, tend to have a greater analgesic response to kappa receptor agonist drugs such as buprenorphine. This is especially true for a specific variant of melanocortin-1 receptor (MC1R), a protein linked to the traits of red hair and fair skin (Mogil et al., 2003). This indicator seems to predict that there are different pathways for some medications such as kappa agonist drugs where greater analgesia is produced in women but not in men (D’Arcy, 2011b; Fillingim & Gear, 2004; Gear et al., 1996). Men had more activation of endogenous opioids when deep tissue stimulation was used as a pain stimulus (Zubieta et al., 2002) A comprehensive review of opioid differences between genders found that men reported less efficacy from analgesia than did women. In order to achieve analgesia, men required higher doses of analgesics, from 24% to 40% more (Miaskowski & Levine, 2004). However, when patient-controlled analgesia (PCA) was used as the medication administration modality, the question was then reduced to opioid consumption and did not address analgesic effect (Mogil & Kest, 2011).

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6 1. The Problem of Pain in Women In a review of 18 studies where PCA was used to administer opioids to postoperative surgical patients, findings indicated that women used less opioid in 10 of the studies, and 8 of the studies found no difference in consumption by sex (Miaskowski, Gear, & Levine, 2000). These findings seem to provide conflicting data from other opioid studies, which further complicates the issue of which sex responds more fully to opioid analgesics. Although these differences in analgesic effect are interesting, what holds more promise is the development of specific medications and methods to provide analgesia to both women and men. This area of research is new and novel and merits attention if we are to improve pain relief for both sexes. More information on differences in opioid medication response can be found in Chapter 11, Effect of Opioid Polymorphisms.

THE ESTROGEN EFFECT As previously noted, estrogen effect was felt to be a variable that most researchers did not want to deal with in pain research. However, excluding females from research studies did not completely control for the effect of hormones, since male subjects also have hormonal testosterone variations, especially over the life span as they age. Gender differences in pain tend to appear during adolescence when hormonal changes occur (Le Resche, 2011). In one group of female patients undergoing in vitro fertilization, despite fluctuations in estrogen levels across the treatment session, there was little effect on pain perception. The control groups in a study that included men had similar positive findings for cold pain perception changes as did the study population. The indication was that variations in pain perception as a result of cold pain stimulus were more related to time across the treatment sessions rather than any hormonal effect from estrogen (Stening et al., 2012). On the cellular level there are mechanisms that indicate estrogen does have more of a role in creating pain. Estrogen is found in nociceptors and estrogen receptors are located in areas of the central and peripheral nervous system that modulate nociception (Chaban, 2012). Estrogen has been found to affect the function of the primary afferent neurons, modulation of voltage gated channels, and purinoreceptor function (Chaban, 2012). Estrogen can also have a very potent preinflammatory effect with women noted to have a more intense inflammatory response when compared to males (Manson, 2011). Estrogen levels tend to fluctuate over the

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Types of Pain

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women’s life span. High levels of estrogen tend to inhibit inflammation such as during the early adult years while lower levels have no effect or a proinflammatory presentation in the perimenopausal years (Manson, 2011). Although not usually studied, the male hormone testosterone can also have an effect on pain in male patients, and research should be developed to further advance the knowledge base of hormonal effect on pain.

TYPES OF PAIN There are several different types of pain that can be experienced by both females and males. Acute pain can be the result of surgery, tissue injury, or treatment. It is a type of pain that occurs suddenly and reflects tissue injury. The patient can expect that this type of pain will not last long. It serves the purpose of letting the body know it has been injured (APS, 2008). Chronic pain is pain that lasts for more than 3 months. This type of pain really is a result of tumor growth or treatment-related pain, such as chemotherapy-related neuropathy (APS, 2008). It is a type of pain that can cause anxiety and depression as time goes on, and if relief is not adequate the patient becomes less certain that relief can be achieved. Neuropathic pain is pain that is the result of damage to the nervous system. Nerve damage can result in physiologic changes that activate higher levels of pain facilitation such as neuronal plasticity and wind-up, activation of N-methyl-D-aspartate (NMDA) receptors that heighten pain response, and allodynia and hyperalgesia. More in-depth information on neuropathic pain will be provided in the chapter on neuropathic syndromes.

Clinical Pearl

Allodynia is the produc on of a painful response to a normally nonpainful s mulus or sensa on, such as a hug. Hyperalgesia is a heightened painful response to a s mulus that is painful; for example, extreme pain with an intravenous catheter inser on.

Determining any sex-related difference between neuropathic and nociceptive pain has been difficult to achieve. There is no evidence to support a higher rate of allodynia or hyperalgesia in female patients.

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8 1. The Problem of Pain in Women

TRANSMISSION OF PAIN

3

Brain processes the message and alerts the body of pain.

Brain

Spinal cord

Nerves

2

Nerves pick up the injury and send the message to the brain.

• Dashed line shows message flow from pain site to brain. • Dotted line shows message going from brain to pain site.

1

Injury occurs in the body.

Figure 1.1 ■ Pain transmission. Source: Used by permission of Anatomical Charts, Park Ridge, IL.

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Transmission of Pain

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The Concept of Nociception How is pain really felt? The concept of nociception can help us determine just how pain moves through the nervous system and it can also provide us with ideas about how we can interfere with pain facilitation and inhibition. Nociception is defined as the perception of pain by sensory pain receptors called nociceptors, located in the periphery (Sorkin, 2005). In the theory of nociception there are four stages of pain transmission. 1. Transduction—A noxious stimulus converts energy into a nerve impulse, which is detected by sensory receptors called nociceptors. 2. Transmission—The neural pain signal moves from the periphery to the spinal cord and brain. 3. Perception—The pain impulse is transmitted to the higher areas of the brain, where it is identified as pain. 4. Modulation—Facilitating and inhibitory input from the brain modulates or influences the sensory transmission at the level of the spinal cord (Berry, Covington, Dahl, Katz, & Miaskowski, 2006; D’Arcy, 2011a). The transmission of pain is basically the passing along of a pain stimulus from the peripheral nervous system into the central nervous system, where it is translated and recognized as pain (Figure 1.1). The afferent nerve fibers are the means of moving the stimulus along the neuronal pathways. Nociception can come from various locations: visceral organs where pain is identified as crampy or gnawing pain; or somatic, pain from skin, muscles, bones, and joints identified by patients as sharp pain (Berry et al., 2006). There are several different types of receptors that can trigger a pain response: ■ Mechanoreceptors —activated by pressure ■ Thermal receptors —activated by heat or cold ■ Chemoreceptors —activated by chemicals, such as inflammatory substances (ASPMN, 2010)

Peripheral Pain Transmission Pain can be first experienced by free nerve endings or nociceptors located in the periphery of the body. When a person cuts a hand or fractures an extremity, the pain stimulus is first perceived in the nerves closest to the injury. In order for a pain stimulus to be created, the sodium ions on the nerve fiber must depolarize, causing the pain stimulus to be produced and passed along the neural circuitry. There are two main types of nerves that transmit pain impulses or stimuli: ■ A-delta fibers are medium-sized, thinly myelinated nerve fibers that can transmit a nerve impulse rapidly, creating the so-called “first pain.” The

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10 1. The Problem of Pain in Women pain transmitted on an A-delta fiber is easily localized and the patient may describe the pain as sharp or stabbing. ■ C fibers are small and unmyelinated, therefore the pain impulse is conducted at a much slower rate, creating “second pain.” Pain that is produced by C fibers is identified by patients as achy or burning in nature (ASPMN, 2010; Sorkin, 2005). Two primary substances can help facilitate the transmission of pain from the periphery. Substance P is a neurotransmitter secreted by the free nerve endings of C fibers, which work to speed the transmission of the pain impulse. Bradykinin is a second type of neurotransmitter, which participates in the inflammatory response and hyperalgesia (ASPMN, 2010). Nociception can stimulate both A-delta and C fibers for pain transmission. Other substances that participate in the facilitation of pain include: ■ Histamine—a substance released from mast cells, produced in response to tissue trauma ■ Serotonin—released from platelets, and produced in response to tissue trauma, causing pain in the periphery ■ COX products—prostaglandins E2 and thromboxane E2 act to sensitize and excite C fibers, causing hyperexcitability ■ Cytokines—interleukins and tumor necrosis factor (TNF) can sensitize C fiber terminals and participate in the inflammatory and infection process involving mast cells ■ Calcitonin gene-related peptides (CGRP)—located at C-fiber nerve endings and produce local cutaneous vasodilatation, plasma extravasation, and skin sanitization in collaboration with substance P production (ASPMN, 2010; Berry et al., 2006; Sorkin, 2005). Once transduction takes place, the nerve impulse is passed from the peripheral nervous system to the central nervous system through a synaptic junction. This synaptic junction has a variety of functions and substances being secreted. Some medications, for example, pregabalin, act at the synaptic junction by blocking calcium channels. This in turn can reduce the amount of neuronal firing and decrease the passage of pain stimuli to the second-order neuron. The synapse is between the first-order (peripheral) neuron and the second-order neuron in the central nervous system.

Central Nervous System Pain Transmission As the pain stimulus is passed from the peripheral nervous system into the central nervous system, the signal passes through the dorsal root ganglion to a synaptic junction in the substantia gelatinosa located in the dorsal horn of the spinal cord. As the stimulus pushing the pain impulse forward overcomes any opposing or inhibiting forces, the “gate” is opened,

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Transmission of Pain

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allowing the pain impulse to proceed up the spinal cord to the brainstem, thalamus, limbic system, and cerebral cortex. The opening of the “gate” in the central nervous system is controlled by a summing of all the forces involved in the conduction of the pain impulse. If the facilitating forces, neural excitability, and pain-facilitating substances such as Substance P predominate, the pain impulse is passed on. If pain-inhibiting forces predominate, the signal is blocked and the gate does not open. If by chance the pain impulse is perceived as potentially life-threatening, a reflex arc across the spinal cord will fire, causing an immediate response to protect the affected area. For example, touching a hot surface causes the body to retract and remove the hand from the hot surface. This event can take place before any central processing (awareness) of the neural signal (Cervaro, 2005). Centrally active pain-facilitating and -inhibitory substances include: Facilitating substances ■ Substance P ■ Glutamate—responsible for communication between the peripheral and central nervous systems (Rowbotham, Kidd, & Porreca, 2006). Also plays a role in activating the NMDA receptors (Mersky, Loeser, & Dubner, 2005) ■ Aspartate ■ Cholecystokinin ■ CGRP ■ Nitric oxide Inhibitory substances ■ Dynorphin, an endogenous opioid ■ Enkephalin ■ Norepinephrine ■ Serotonin (note: serotonin is facilitative in the peripheral nervous system, but inhibitive in the central nervous system) ■ B-endorphin—an endogenous opioid ■ Gamma-aminobutyric acid (GABA) (ASPMN, 2010; Sorkin, 2005) Also performing an inhibitory role are the opioid receptors located both presynaptically and postsynaptically, which are available for binding opioid substances such as morphine and producing analgesia. Although there are opioid receptors located at other sites in the body, those that are located inside the spinal cord have the most information available about how they function. As the pain impulse passes through the dorsal horn of the spinal cord, it passes across the spine to the lateral spinothalamic tracts, which then allow the pain impulse to proceed up to the thalamus and limbic system, activating the emotions and memories associated with pain.

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12 1. The Problem of Pain in Women The pain impulse then travels on to the cerebral cortex, where the pain impulse or stimulus is recognized as pain. Although this process seems complicated, the body can conduct a pain impulse in only milliseconds. Within the limbic system two pain substances, norepinephrine and serotonin, are active. Current drug therapies such as tricyclic antidepressants (TCAs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) are aimed at this process and use the substances to reduce the amount of norepinephrine available to activate neuronal firing at synaptic junctions. The synaptic junctions have such a variety of functions that they are important not only for passing on the pain impulse, but also for serving as critical sites for modulating pain by controlling the production of painfacilitating substances and actions. Once the pain stimulus reaches the cerebral cortex, the aff erent pathway is completed. At that time, the eff erent nerve fibers are used to pass the neuronal response identified as pain back to the periphery or affected area. Descending nerve fiber from the locus coeruleus and periaqueductal gray matter are activated. Interpretation of the pain stimulus is then passed back down the efferent pathway where a response to the pain stimulus is produced, such as moving the affected area away from the pain stimulus. It is important to remember that pain transmission not only takes place when a stimulus is created and ascends the spinal cord, but that the descending neural pathways can also function to inhibit or limit the pain stimulus. This is called descending modulation of pain. In the case of neuropathic pain, the descending pathways do not inhibit the pain response and the pain is more difficult to control. An example of this phenomenon is fibromyalgia, where the descending pathways do not stop the pain stimulus in the descending pathways, allowing for high levels of pain to be created.

BARRIERS TO TREATING PAIN IN WOMEN Although women have been noted to seek help for pain more frequently than men, there is still not enough information to make definitive statements about the sex and gender differences in pain and analgesic response. It is difficult to correlate research findings to clinical settings. Research is also trying to differentiate ethnic and genetic difference in pain response and analgesic efficacy. Given the wide range of topics for research studies and the limited ability of researchers to provide answers to the questions of sex and gender differences in pain response to both stimulus and analgesics, it will be some time before we can say with certainty that there is an identifiable difference in the sexes with the experience of pain.

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References

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Case Study Amanda, 48 years of age, is being admitted for an abdominal hysterectomy. She has had surgery in the past and reports difficulty with anesthesia and prolonged nausea and vomiting after surgery. She also has a history of fibromyalagia. She tells the anesthesiologist that the surgical drugs just don’t agree with her. When you speak to Amanda she reports that she has had problems with her postoperative pain as well. She had orthopedic surgery not too long ago and reports that her pain was very severe and that the medications just “didn’t work too well.” You ask what types of medications she was given and she responds that she had a morphine PCA, and Percocet as oral medication when the PCA was discontinued. You note that Amanda is slightly overweight, is red-headed, and has a very fair complexion. You reassure Amanda that you will work with her to provide better analgesia than during her last surgery.

Questions to Consider 1. Does the fact that Amanda is female, red-headed, and fair make it more difficult to control her pain postoperatively? 2. What type of medication would you consider for Amanda after her surgery, considering that morphine was not effective during her last hospitalization? 3. Does the fact that Amanda has fibromyalgia make a difference in how she will respond to her surgical pain? 4. Would Amanda be a patient who could experience hyperalgesia or allodynia?

REFERENCES American Pain Society. (2008). Principles of analgesic use in acute and cancer pain. Glenview, IL: Author. American Society for Pain Management Nursing. (2010). Core curriculum for pain management nursing (2nd ed.). Dubuque, IA: Kendall Hunt Publishing Company. Berry, P. H., Covington, E., Dahl, J., Katz, J., & Miaskowski, C. (2006). Pain: Current understanding of assessment, management, and treatments. Reston, VA: National Pharmaceutical Council.

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14 1. The Problem of Pain in Women Cervaro, F. (2005). The gate control theory, then and now. In H. Mersky, J. Loeser, & R. Dubner (Eds.), Paths of pain. Seattle, WA: IASP Press. Collett, B., & Berkley, K. (2007). The IASP Global Year Against Pain in Women. Pain, 132, S1–S3. Chaban, V. (2012). Estrogen and visceral nociception at the level of primary sensory neurons. Pain Research and Treatment, 2012, 1–6. Dahan, A., Kest, B., Waxman, A. R., & Sarton, E. (2008). Sex-specific response to opiates: Animal and human studies. Anesthesia & Analgesia, 107(1), 83–95. D’Arcy, Y. (2011a). Compact clinical guide to chronic pain management. New York, NY: Springer Publishing Company. D’Arcy, Y. (2011b). Women’s pain management issues. Pain Management Nursing, 12 (1), S1–S3. Fillingim, R. (2010). Individual differences in pain: The roles of gender ethnicity, and genetics. In S. Fishman, J. Ballantyne, & J. Rathmell (Eds.). Bonica’s management of pain (pp. 86–90). Philadelphia PA: Lippincott Williams & Wilkins. Fillingim, R., & Gear, R. (2004). Sex differences in opioid analgesia: Clinical and experimental findings. European Journal of Pain, 8, 413–425. Gear, R. W., Miaskowski, C., Gordon, N. C., Paul, S. M., Heller, P. H., & Levine, J. D. (1996). Kappa-opioids produce significantly greater analgesia in women than in men. Nature Medicine, 2, 1248–1250. Greenspan, J., Craft, R., LeResche, L., Arendt-Nielsen, L., Berkley, K., Filligim, R., & Traub, R. (2007). Studying sex and gender differences in pain and analgesia: A consensus report. Pain, 132 (Suppl. 1), S26–S45. Hurley, R., & Adams, M. (2008). Sex, gender and pain: An overview of a complex field. Pain Mechanisms, 107(1), 309–317. Le Resche, L. (2011). Defining gender disparities in pain management. Clinical Orthopaedics and Related Research, 469, 1871–1877. Manson, J. (2011). Pain: sex differences and implications for treatment. Metabolism Clinical and Experimental , 59 (Suppl. 1), S16–S20. Mersky, H., Loeser, J., & Dubner, R. (2005). The paths of pain. Seattle, WA: IASP Press. Miaskowski, C., Gear, R. W., & Levine, J. D. (2000). Sex-related differences in analgesic response. In R. B. Fillingim (Ed.), Sex gender & pain (pp. 209–239). Seattle, WA: IASP Press. Miaskowski, C., & Levine, J. (2004). Sex differences in pain perception, response to treatment, and clinical management. In R. H. Dworkin & W. S. Breitbart (Eds.), Psychosocial aspects of pain: A handbook for healthcare providers (pp. 607–621). Seattle, WA: IASP Press. Mogil, J. (2009). Animal models of pain: Progress and challenges. Nature Reviews Neuroscience, 10 (4), 283–294. Mogil, J., & Chanda, M. (2005). The case for inclusion of female subjects in basic science studies of pain. Pain, 117, 1–5. Mogil, J., & Kest, B. (1999). Sex differences in opioid analgesia: Of mice and women. Pain Forum, 8 (1), 48–50. Mogil, J., Wilson, S., Chesler, E., Rankin, A., Nemmani, K., Lariviere, W., . . . Fillingim R. (2003). The melnocortin-1 receptor gene mediates female-specific mechanisms of analgesia in mice and humans. PNAS, 100 (8), 4867–4872.

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Additional Resources

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Racine, M., Tousignant-LaFlamme, Y., Kloda, L., Dion, D., Dupuis, G., & Choiniere, M. (2012a). A systematic literature review of 10 years of research on sex/gender and experimental pain perception—Part 1: Are there really differences between women and men? Pain, 153, 602–618. Racine, M., Tousignant-LaFlamme, Y., Kloda, L., Dion, D., Dupuis, G., & Choiniere, M. (2012b). A systematic literature review of 10 years of research on sex/gender and pain perception—Part 2: Do biopsychosocial factors alter pain sensitivity differently in women and men? Pain, 153, 619–635. Rowbotham, M., Kidd, B., & Porreca, F. (2006). Role of central sensitization in chronic pain: Osteoarthritis and rheumatoid arthritis compared to neuropathic pain. In H. Flor, E. Kalso, & J. Dostrovsky (Eds.), Proceedings of the 11th World Congress on Pain. Seattle, WA: IASP Press. Sorkin, L. (2005). Nociceptive pain. In M. S. Wallace & P. S. Staats (Eds.), Pain medicine & management. New York, NY: McGraw-Hill. Stening, K., Berg, G., Hammar, M., Voster, H., Eriksson, O., Amundson, A., & Blomquist, A. (2012). Influence of estrogen levels on thermal perception, pain thresholds and pain tolerance: Studies on women undergoing in vitro fertilization. Journal of Pain, 13 (5), 459–466. Tousignant-LaFlamme, Y., Rainville, P., & Marchand, S. (2005). Establishing a link between heart rate and pain in healthy subjects: A gender effect. Journal of Pain, 6(6), 341–347. World Health Organization website. Retrieved from http://www.who.int/cancer/en Zubieta, J., Smith, Y., Bueller, J., Xu, Y., KIlbourn, M., Jewett, D., . . . Stohler, C. (2002). Mu-opioid receptor mediated antinociceptive responses differ in men and women. Journal of Neuroscience, 22 (12), 5100–5107.

ADDITIONAL RESOURCES Fillingim, R., King, C., Ribiero-Dasilva, M., Rahim-Williams, B., & Riley, J. (2009). Sex, gender, and pain: A review of recent clinical and experimental findings. The Journal of Pain, 10 (5), 447–485. Fillingim, R., & Ness, T. (2000). Sex-related hormonal influences on pain and analgesic responses. Neuroscience and Biobehavioral Reviews, 24, 485–501.

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2 The Art and Science of Pain Assessment

Assessing pain in women can be difficult due to their focus on functionality and pain’s impact on daily functioning. Although women seek help from health care providers more frequently than men, they can downplay their pain if it will negatively impact work or family life. When assessing pain in patients it is important for health care providers to ensure that the female patient feels that the person assessing the pain values the information and responds to it appropriately. Because there are several different types of pain, nurses need to learn how to help the patient identify each type of pain for assessment. Questions related to the quality of pain, and descriptors such as burning or tingling, may reveal the cause as neuropathic pain, which can affect treatment options. Careful questioning about how long the pain has been problematic, how it affects daily life, and how the patient has tried to relieve the pain can yield helpful information for planning care. Breakthrough pain in women with chronic pain can also have several sources, such as end-of-dose failure or sudden onset of a new pain in a patient with well-controlled pain, so careful identification of when and how often the pain occurs is needed to differentiate from the patient’s baseline pain (D’Arcy, 2011b). From the patient perspective, pain is also something that tends to be minimized or not reported, fearing a negative response from a health care provider. For each health care provider who assesses the patient there must be an awareness of these issues so that the patient will feel comfortable talking about pain management concerns with all members of the health care group. Accurate pain assessment has been problematic for nurses and other health care professionals because it relies on the patient’s self-report. In a recent survey of 3,000 nurses and another survey with 400 nurse practitioners, pain assessment was cited as a major source of concern and knowledge deficit (D’Arcy, 2008, 2009). Many of the nurses who responded to the

17

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18 2. The Art and Science of Pain Assessment survey felt that they were not getting a pain assessment that was accurate. In the nurse practitioner survey, the respondents indicated that they felt their nurse practitioner education had not prepared them to treat or assess pain in patients with chronic pain (D’Arcy, 2009). There were repeated requests in the comments section of the survey for education on performing an accurate pain assessment and how to assess pain in patients with chronic pain and/or a history of substance abuse. Despite the years of education on pain assessment that has been provided to nurses and other health care professionals, pain assessment still remains difficult because of its subjectivity. Pain assessment is problematic because: ■ It relies on patient self-report ■ Health care providers have difficulty trusting the patient’s report of pain ■ The assessment process uses an objective scale to convey a subjective experience ■ The health care provider comes to the patient interaction with bias as a result of family and personal values and beliefs about pain (American Society for Pain Management Nursing [ASPMN], 2009; D’Arcy, 2007) Pain assessment is the core component to developing and implementing care and providing adequate pain management for patients. Choosing a medication to treat pain is driven by the assessment process. Additionally, adjustments to the patient’s plan of care are based on the patient’s response to the intervention as determined by pain assessment and reassessment (Ackely, Ladwig, Swan, & Tucker, 2008; Berry, Covington, Dahl, Katz, & Miaskowski, 2006). If pain is not assessed well, it can result in undertreated or untreated pain that can have a significant effect on the patient. For acute pain, untreated or undertreated pain can limit mobility, which can result in a serious complication such as pneumonia or deep vein thrombosis. It can also delay discharge or impair recovery, and it may in some cases result in a difficult-to-treat chronic pain condition such as complex regional pain syndrome (CRPS) (American Pain Society [APS], 2008; D’Arcy, 2007). For chronic pain, untreated or undertreated pain can limit functionality, increase the potential for disability, cause suffering, and decrease the patient’s quality of life by causing anxiety, fear, depression, anxiety, and uncertainty (Berry et al., 2006). For all pain patients, but especially for women, pain assessment is challenging because of the multifaceted nature of the pain. In the past, women were seen as having a more emotional response to pain than men. It may be that women are more open to sharing their feelings about the pain as well as the objective information that most health care providers use for assessment. The patient comes to the experience with not only physiological pain, but also psychological responses such as depression, changes in relationships,

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The Art and Science of Pain Assessment

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potential impact on lifestyle related to the inability to work, and emotional needs. To fully convey those varied elements of the pain experience in a single number is not a reasonable expectation. Multidimensional pain assessment scales or interviews are needed to assess all aspects of the pain experience. For patients with chronic pain, such as female patients with osteoarthritis, fibromyalgia, or vulvodynia, functionality may be a better indicator of pain relief than a change in numeric intensity pain ratings (Ackely et al., 2008; D’Arcy, 2007; Jensen, 2011). Some patients do not understand the term “functionality.” The concept of “impact on daily activity” might be better understood. Questions that can provide good insight into the patient’s ability to perform the needed tasks of daily living include: ■ How far can you walk independently? With assistance? ■ Who does the cooking/washing/cleaning at your house? ■ How many stairs can you climb before you need to stop? ■ Do you go to the movies/church/visit family? ■ Can you go grocery shopping? ■ What can’t you do now that you could do 3 months ago? ■ For patients with younger children, who provides the majority of the child care? ■ Can you maintain an intimate relationship with your partner? If possible, it is always good to observe the patient while walking or moving from one position to another. For example, if the patient is sitting in a chair and is called into the health care provider’s office, does the patient need several attempts to get into a standing position? Does she use the arms of the chair to push herself up? Does the patient need assistive devices such as a walker to move? Does the patient limp or favor one extremity over another? All of these examples can indicate that pain is significantly limiting the patient’s ability to move freely or function. For patients with fibromyalgia, fatigue will have a significant impact on functionality. The health care team should be aware of differentiation between the impact of pain and the effect of fatigue.

Clinical Pearl

W hen assessing a pa ent with chronic daily pain, always ask the pa ent to iden fy her best and worst daily pain levels. Set a pain goal that refl ects a pain level that is achievable in comparison to the best and worst pain ra ngs the pa ent provides. Some pa ents with chronic pain can func on with pain levels that would be prohibi ve for other individuals.

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20 2. The Art and Science of Pain Assessment Many of the original pain assessment tools were designed for research and were one-dimensional, only measuring the intensity of the pain. Because of the complexity of chronic pain, multidimensional pain assessment tools are needed to assess chronic pain. These more comprehensive tools include a pain intensity rating but also include questions about the effectiveness of pain medications, the patient’s mood, quality of the pain, and impact on activity (functionality). For patients who cannot use self-report, such as obtunded, intubated, critically ill patients or end-of-life, demented, or cognitively impaired elderly, behavioral scales have been developed to help assess pain. The following sections of the chapter will discuss specific pain assessment tools and techniques.

ASSESSMENT Assessing pain is a subjective process; it is more an art than a science. In the past, the pain response for women has been viewed as more emotional. Using a pain intensity rating combined with other assessment tools such as an interview-type assessment can provide a better picture of the pain and its impact on daily life. For verbal patients, self-report is the standard for assessing pain. To perform a standard pain assessment, the nurse asks the patient to rate pain intensity using a simple one-dimensional scale such as the numeric rating scale (NRS). The NRS is an 11-point Likert-type scale, with 11 numbers ranked from 0, no pain, to 10, worst possible pain, to indicate pain severity. The higher the number selected by the patient, the more severe the pain intensity. This type of assessment is most useful for assessing pain intensity and medication efficacy. The basic elements of a pain assessment for verbal patients include: Location — Have the patient point to the area on the body that is painful. For multiple painful areas, have the patient locate each one individually and indicate when the pain occurs at that location. If one area is more painful than the next, make sure the most painful area is clearly identified. If there is a radiation of pain, e.g., down a leg or arm, make sure the area is clearly defi ned so that the correct treatment options can be determined. A body diagram (Figure 2.1 is an example) can be helpful when the patient is trying to locate the pain. Using colors for pain in different parts of the body can also help determine any differences in pain intensity. Red can indicate a more severe level of pain while blue can indicate pain that is less intense. Patients like to use different ways to communicate the exact location and intensity of the pain they are experiencing.

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Assessment

21

Figure 2.1 ■ Body pain diagram.

Duration — Ask the patient “When did you first feel this pain?” and “How long does the pain last?” Explore any potential sources or causes of the pain. Ask if the pain intensity varies during different times of the day and how long the periods of higher intensity pain last. Intensity — Use the NRS to have the patient rate the intensity of the pain. If the patient has any times of the day or night when the pain intensity is more or less severe, ask if the prescribed medication reduces the intensity of the pain. If the patient is taking pain medication, determine how effective the patient feels it is at decreasing the pain intensity. Other options for determining pain intensity if the patient cannot use the NRS are to use the terms mild, moderate, or severe to see if a range for pain intensity can be determined. Quality/description — Have the patient describe the quality of the pain. This may be one of the most important items in the assessment process. If the patient uses words like burning, tingling, or painful numbness, it may indicate a neuropathic source for the pain. It is important to allow the patient to describe the pain in her own words so it is most accurately represented.

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22 2. The Art and Science of Pain Assessment Alleviating/aggravating factors — Like all American health care consumers, patients have some form of home treatment for pain and they most often will attempt to treat their pain before they seek health care with over-the-counter medications like acetaminophen, gels or creams such as Icy Hot or Ben Gay, or plain ice packs. If the patient has tried some form of pain relief, ask if it made the pain better or worse. Ask the patient if activity made the pain worse or if rest improved the pain. Ask the patient if any one position is better than the other for relieving the pain. Ask about stress levels and what the patient does to reduce stress. Pain management goal — For most patients with pain, achieving a pain-free state is not a valid goal. Surgical patients will need to recover to significantly reduce the immediate pain of the procedure. Patients with chronic pain will need to determine what level of pain is acceptable since removing all the persistent pain is not a real possibility. Work with the patient to set a goal that is reasonable and achievable. Ask the patient what pain intensity is acceptable and then tailor pain interventions to achieve the patient’s expectations. Consistent pain reassessment will track progress toward the goal that has been set. Function goal — Pain is dynamic and increases with activity (Dahl & Kehlet, 2006). Ask the patient how the pain interferes with her activities of daily living. Assess the patient for sleep disturbances that can affect the patient’s ability to function. By setting a functionality goal, progress can be tracked at each subsequent visit. Including the patient in the assessment process gives the patient a feeling of validation and encourages him or her to work toward the pain and functional goal. Providing maximum pain relief, the highest quality of life, and the highest functionality are the goals of any pain-relief treatment (Ackley et al., 2008; ASPMN, 2009; D’Arcy, 2003, 2007, 2011a; Joint Commission on Accreditation of Healthcare Organizations [JCAHO], 2000). The above elements work well for patients who are able to self-report their pain. Using the Hierarchy of Pain Assessment can help delineate the assessment process for patients who are not able to report pain. Using this technique is especially helpful for patients at the end of life or who have baseline dementia.

Hierarchy of Pain Assessment ■ ■ ■ ■ ■

Attempt a self-report of pain. The patient’s self-report is the best way to assess for pain Search for potential causes of the pain Observe patient behaviors Use surrogate reporting Attempt an analgesic trial (Herr, Bjoro, & Decker, 2006a)

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Assessment

23

In addition to the Hierarchy of Pain Assessment, using the basic elements below in practice can help standardize the assessment process for these patients. ■ Use the Hierarchy of Pain Assessment techniques ■ Establish a procedure for pain assessment ■ Use behavioral pain assessment tools, when appropriate ■ Minimize emphasis on physiologic indicators ■ Reassess and document (Herr, 2006a) The most critical aspect of the pain assessment process for the nurse and other members of the health care team is to believe the patient’s report of pain. Patients do the very best they can to provide you with an accurate picture of the complex pain they are experiencing. Some women may have had a bad experience previously, where they felt their pain report was not believed or not valued. They may seem closed or distant when questioned about pain levels. It is extremely important for the nurse to respect the patient’s report of pain as presented and then in good faith act to help relieve the pain. If the health care provider doubts or diminishes the patient’s report of pain, trust will be lost and the patient will not be open to believing that the health care provider is interested in treating and managing the pain. This lack of trust can sabotage even the best plan of care. Telling the patient that you believe she has pain can be one of the most powerful statements you can make to the patient. Approach the assessment process with a nonjudgmental attitude and a willingness to believe and invest time in helping the patient with her pain. This personal connection with the patient will yield tremendous benefits in creating a trusting relationship that can be so useful in the long-term treatment plan for pain. The use of in-depth questions to collect all the salient information during the assessment process will help to determine the kind of interventions that will be most helpful in providing the best possible pain relief for the patient. Using a reliable and valid pain assessment tool provides objective criteria for pain assessment and provides a means of tracking progress toward patient goals. Clinical Pearl

I n order to set up open communica on with the pa ent, encourage the pa ent to report the pain to the best of her ability. Acknowledge that it is o en diffi cult to describe pain. Value the pa ent’s report of pain and make clear that you believe she is in pain. Failure to believe the pa ent’s report of pain can result in a faulty assessment process, which can lead to nega ve outcomes.

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24 2. The Art and Science of Pain Assessment

PAIN ASSESSMENT TOOLS Many of the first pain assessment tools were developed for assessing pain in experimentally induced pain, chronic pain, or oncology pain (Jensen, 2011). The multidimensional scales are extensions of the one-dimensional scales and were developed to assess more complex pain, including measurements of mood and psychological elements. Today there are a wide variety of valid and reliable pain assessment tools. More recently, as The Joint Commission required that all patients have their pain assessed and adequately treated, tools for assessing pain in special populations such as the cognitively impaired, nonverbal patients, and infants have been developed to meet the needs of these patients.

ONEDIMENSIONAL PAIN SCALES Although unidimensional pain assessment tools are limited in scope, they are most helpful for determining if pain medication or a pain intervention is reducing the intensity of the pain. Although these tools seem very simple and the information obtained is limited, there is definitely a place for these tools in pain assessment. In order to get a more complete picture of the patient’s pain, use the intensity rating as a starting point, with additional questions adding more depth to the pain report. In a review of 164 journal articles on pain assessment, single-item ratings of pain intensity were reported as valid and reliable indicators of pain intensity (Ackely et al., 2008; Jensen, 2003). As an indication of efficacy, Farrar, Young, Lamoreaux, Werth, and Poole (2001) determined that a 2-point or 30% reduction in pain intensity on the NRS is a clinically significant change.

Visual Analog Scale (VAS) 0 No Pain

10 Worst Possible Pain

Figure 2.2 ■ The Visual Analog Scale (VAS).

The VAS (Figure 2.2) is a 100-mm line with no pain at one end (0 mm) and the worst pain possible at the other end (100 mm). The tool was designed to be used for research, where a mark could easily be measured to ascertain the intensity of the pain. To use the VAS, the nurse asks the patient to mark on the line where the pain intensity she is feeling is best represented. If the patient marks

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One-Dimensional Pain Scales

25

the line at the 50-mm position, the pain would be said to be 5/10 when compared to the NRS, or moderate-level pain. The VAS is one of the most basic scales and has some limitations for using it clinically. Limitations of this scale include: ■ Some older adult patients have difficulty marking on the line, and place the mark above or below the 100-mm line (Herr & Mobily, 1993) ■ Reassessment and comparison options are limited

Verbal Descriptor Scale (VDS) No Pain

Mild Pain

Moderate Pain

Severe Pain

Very Severe Worst Possible Pain Pain

Figure 2.3 ■ The Verbal Descriptor Scale (VDS).

The purpose of the VDS (Figure 2.3) is to provide a method for patients to use word descriptors to rate their pain. The scale is anchored on one end with no pain, with the opposite-end anchor indicating high-intensity pain and labeled as the worst possible pain. The scale uses words such as mild, moderate, and severe to measure pain intensity. To use the scale the nurse asks the patient to select the word that best describes the pain she is experiencing. Clinically, some patients prefer to use a word to describe their pain rather than a number. Although normally used for cognitively intact patients, Feldt, Ryden, and Miles (1998) found a 73% completion rate with the VDS in cognitively impaired patients. Limitations of this pain scale include: ■ Patient must be able to understand the meaning of the words ■ Reassessment and comparisons are difficult

Numeric Rating Scale (NRS) 0 No Pain

1

2

3

Mild Pain

4

5

6

Moderate Pain

7

8 Severe Pain

9

10 Worst Possible Pain

Figure 2.4 ■ Numeric Rating Scale (NRS).

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26 2. The Art and Science of Pain Assessment The NRS (Figure 2.4) is the most commonly used one-dimensional pain scale. It is an 11-point Likert-type scale where 0 means “no pain” and 10 means “worst possible pain.” To use the scale, the nurse asks the patient to rate her pain intensity. The higher the number is, the more intense the pain. Mild pain is considered to be pain ratings in the 1 to 3 range Moderate pain is considered to be pain ratings in the 4 to 6 range Severe pain is considered to be pain ratings in the 7 to 10 range Although there is discussion about whether a single-number rating of pain is accurate, the data indicate that single-item ratings can be useful. For many chronic pain conditions that women experience, the pain intensity rating is only one of many ways that their pain will be assessed. There is no good or bad, wrong or right number for the patient to report. It is important to believe the report of pain that the patient provides. Patient self-report is still considered to be the gold standard for pain assessment (APS, 2008). Limitations: ■ Only measures one aspect of pain Strengths: ■ Allows for reassessment and comparison of pain scores ■ Simple format that is easy for most patients to use ■ Can be used to help determine the efficacy of medication and other pain interventions

Combined Thermometer Scale Some patients do better with pain assessment when they can see a graphic pain scale. The Combined Thermometer Scale (Figure 2.5) combines onedimensional scales: the VDS and the NRS. The original thermometer scale was developed for research studies at the University of Iowa. Some patients do well with this scale and like the vertical orientation where the numbers increase from the bottom upward. The changes in color also highlight the changing pain intensity as the color merges from blue to red. (The Combined Thermometer Scale appears in color on the inside front cover.) Strengths: ■ Able to replicate pain ratings for reassessment ■ Simple, easy-to-use format ■ Oriented on a vertical axis with low pain ratings at the bottom and higher pain ratings higher up

MULTIDIMENSIONAL PAIN SCALES Multidimensional scales are used to assess patients with chronic and cancer pain who can have a variety of pain conditions. The two scales that are

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Multidimensional Pain Scales

27

Pain Distress/Intensity Scale

Agonizing

10 9

Horrible

8 7

Dreadful

6

Worst Possible Pain Very Severe Pain Severe Pain

5 Uncomfortable

4 3

Annoying

2

Moderate Pain Mild Pain

1 None

0

No Pain

Figure 2.5 ■ Combined Thermometer Scale.

most often used in the clinical setting are the McGill Pain Questionnaire (MPQ) (Figure 2.6) and the Brief Pain Inventory (BPI) (Figure 2.7). The difference between the one-dimensional and multidimensional scales is the combination of indexes in the multidimensional scale that can measure: ■ Pain intensity ■ Mood ■ A body diagram to locate pain ■ Verbal descriptors ■ Medication efficacy questions When the patient rates her pain using a multidimensional pain scale, there is the opportunity for the patient to more completely convey the pain experience to the health care provider. The mood scales on some multidimensional scales can help define the impact of the continued pain on the patient’s personal life and relationships.

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28 2. The Art and Science of Pain Assessment These scales are meant to be used to measure chronic and cancer pain either for research or for clinical use.

McGill Pain Questionnaire (MPQ) McGill Pain Questionnaire (MPQ)–Short Form PATIENT’S NAME: ______________________________________

DATE: ___________________

NONE

MILD

MODERATE

SEVERE

THROBBING

0) ______

1) ______

2) ______

3) ______

SHOOTING

0) ______

1) ______

2) ______

3) ______

STABBING

0) ______

1) ______

2) ______

3) ______

SHARP

0) ______

1) ______

2) ______

3) ______

CRAMPING

0) ______

1) ______

2) ______

3) ______

GNAWING

0) ______

1) ______

2) ______

3) ______

HOT/BURNING

0) ______

1) ______

2) ______

3) ______

ACHING

0) ______

1) ______

2) ______

3) ______

HEAVY

0) ______

1) ______

2) ______

3) ______

TENDER

0) ______

1) ______

2) ______

3) ______

SPLITTING

0) ______

1) ______

2) ______

3) ______

TIRING/EXHAUSTING

0) ______

1) ______

2) ______

3) ______

SICKENING

0) ______

1) ______

2) ______

3) ______

FEARFUL

0) ______

1) ______

2) ______

3) ______

PUNISHING/CRUEL

0) ______

1) ______

2) ______

3) ______

VAS

NO PAIN

WORST POSSIBLE PAIN

PPI 0 1 2 3 4 5

NO PAIN MILD DISCOMFORTING DISTRESSING HORRIBLE EXCRUCIATING

© R. Melzack 1984

The short-form McGill Pain Questionnaire (SF-MPQ). Descriptors 1–11 represent the sensory dimension of pain experience and 12–15 represent the affective dimension. Each descriptor is ranked on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The Present Pain Intensity (PPI) of the standard long-form McGill Pain Questionnaire (LF-MPQ) and the visual analogue scale (VAS) are also included to provide overall intensity scores. Source: Reprinted with permission from R. Melzack. © R. Melzack, 1984.

Figure 2.6 ■ McGill Pain Questionnaire.

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Multidimensional Pain Scales

29

The MPQ is a multidimensional tool designed to measure pain in patients with complex pain conditions such as chronic pain. This pain scale has been used to assess some of the following conditions: ■ Experimentally induced pain ■ Postprocedural pain ■ Various medical–surgical conditions The tool contains a VAS scale, a present pain intensity (PPI) scale, and a set of verbal descriptors used to capture the sensory aspect of the pain experience. The tool has been widely used in a variety of settings, has been found to be reliable and valid, and has been translated into a number of foreign languages (Chok, 1998; MacIntyre, Hopkins, & Harris, 1995; McDonald & Weiskopf, 2001; Melzack, 1975, 1987; Mystakidou et al., 2002; Graham et al., 1980; Wilkie, Savedra, Holzmer, Tesler, & Paul, 1990) Strengths: ■ High level of reliability and validity Limitations: ■ Difficulty scoring and weighting the verbal descriptor section ■ Difficulty translating the verbal descriptor section into words that indicate syndromes (Gracely & Dubner, 1987; Graham et al., 1980) ■ Cannot be used in cognitively impaired patients

Brief Pain Inventory (BPI) Originally, the BPI (Figure 2.7) was first used with oncology patients to assess long-term oncology pain. With further use it has been found to be reliable and valid for assessing pain in patients with chronic pain (Daut, Cleeland, & Flannery, 1983; Raiche, Osborne, Jensen, & Cardenas, 2006; Tan, Jensen, Thornby, & Shanti, 2004; Tittle, McMillan, & Hagan, 2003; Williams, Smith, & Fehnel, 2006), and has been translated into a variety of languages (Ger, Ho, Sun, Wang, & Cleeland, 1999; Klepstad et al., 2002; Mystakidou et al., 2002; Radbruch et al., 1999). It has a simple, easy-to-use format that can be used as an interview or as a self-report that is completed by the patient. The BPI includes: ■ A pain intensity scale ■ A body diagram to locate the pain ■ A functional assessment ■ Questions about the efficacy of pain medications Strengths: ■ High level of reliability and validity Limitations for the BPI include: ■ The patient must be cognitively intact to answer questions related to her individual pain condition

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30 2. The Art and Science of Pain Assessment

STUDY ID #:_ _ _ _ _ _ _ _ _ _

HOSPITAL #: _ _ _ _ _ _ _ _ _ _

DO NOT WRITE ABOVE THIS LINE

Brief Pain Inventory (Short Form) Date: _ _ _ _ / _ _ _ _ / _ _ _ _ Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Time: _ _ _ _ _ _ _ ___________________ ______________

Last

First

Middle Initial

1.

Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?

2.

On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most.

1.

Yes

2.

Front Right

3.

4.

5.

6.

No

Back Left

Left

Right

Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours. 0 1 2 3 4 5 6 7 8 9 10 No Pain as bad as Pain you can imagine Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours. 0 1 2 3 4 5 6 7 8 9 10 No Pain as bad as Pain you can imagine Please rate your pain by circling the one number that best describes your pain on the average. 0 1 2 3 4 5 6 7 8 9 10 No Pain as bad as Pain you can imagine Please rate your pain by circling the one number that tells how much pain you have right now. 0 No Pain

1

2

3

4

5

6

7

8

9

10 Pain as bad as you can imagine

Page 1 of 2

Figure 2.7 ■ Brief Pain Inventory. Source: Used with permission of the author.

(continued)

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Multidimensional Pain Scales

STUDY ID #:_ _ _ _ _ _ _ _ _ _

HOSPITAL #: _ _ _ _ _ _ _ _ _ _

DO NOT WRITE ABOVE THIS LINE

Date: _ _ _ _/ _ _ _ _ / _ _ _ _ Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Time: _ _ _ _ _ _ _ _ ___________________ ______________

Last

First

Middle Initial

7.

What treatments or medications are you receiving for your pain?

8.

In the last 24 hours, how much relief have pain treatments or medications provided? Please circle the one percentage that most shows how much relief you have received.

9.

31

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% No Complete Relief Relief Circle the one number that describes how, during the past 24 hours, pain has interfered with your: A. General Activity 0 1 2 3 Does not Interfere B. Mood 0 1 2 Does not Interfere

3

C. Walking Ability 0 1 2 3 Does not Interfere

4

5

6

7

8

9

10 Completely Interferes

4

5

6

7

8

9

10 Completely Interferes

4

5

6

7

8

9

10 Completely Interferes

D. Normal Work (includes both work outside the home and housework) 0 1 2 3 4 5 6 7 8 9 10 Does not Completely Interfere Interferes E. Relations with other people 0 1 2 3 4 5 Does not Interfere F. Sleep 0 1 2 Does not Interfere

3

G. Enjoyment of life 0 1 2 3 Does not Interfere

6

7

8

9

10 Completely Interferes

4

5

6

7

8

9

10 Completely Interferes

4

5

6

7

8

9

10 Completely Interferes

Copyright 1991 Charles S. Cleeland, PhD Pain Research Group All rights reserved

Page 2 of 2

Figure 2.7 ■ Brief Pain Inventory, continued.

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32 2. The Art and Science of Pain Assessment

THE BRIEF PAIN IMPACT QUESTIONNAIRE BPIQ Some women may find a tool like the BPIQ (Exhibit 2.1) a better way to assess pain, especially for the intake visit. The tool was developed as a quick and easy way to assess pain using a series of questions in an interview format. The information provided covers pain intensity, functional impairment, health status, and alcohol use. Since this tool uses a simple interview format, it can pinpoint problem areas such as functional impairment very quickly. It can also open up a discussion if the health care provider sees the patient has difficulty answering a question. Exhibit 2.1 Brief Pain Impact Questionnaire (BPIQ) ■ How strong is your pain, right now, and at its worst or average over

the past week? ■ How many days over the past week have you been unable to do what

you would like to do because of your pain? ■ Over the past week, how often has pain interfered with your ability

■

■

■ ■ ■ ■ ■ ■ ■ ■

to take care of yourself, for example, with bathing, eating, dressing, or going to the toilet? Over the past week, how often has your pain interfered with your ability to take care of your home-related chores such as grocery shopping, preparing meals, paying bills, or driving? How often do you participate in pleasurable activities such as hobbies, socializing with friends, or travel? Over the past week, how often has pain interfered with these activities? How often do you do some type of exercise? Over the past week, how often has pain interfered with your ability to exercise? Does pain interfere with your ability to think clearly? Does pain interfere with your appetite? Have you lost weight? Does pain interfere with your ability to sleep? How often over the last week? Has pain interfered with your energy, mood, personality, or relationship with other people? Over the past week, have you taken pain medications? Has your use of alcohol or other drugs ever caused a problem for you or those close to you? How would you rate your health at the present time? (Weiner, Herr, & Rudy, 2002)

Source: Used with permission from the author.

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Behavioral Pain Scales

33

BEHAVIORAL PAIN SCALES As of 2001, The Joint Commission created pain standards for inpatient care that have set a standard for outpatient practice as well. One of the biggest focus areas in The Joint Commission standards was pain assessment for all patients, which included assessing pain in individuals who could not self-report their pain. Many women survive their spouses and live to old age, needing care in extended living facilities. The American Geriatrics Society (AGS, 2002) has found that the prevalence of pain in nursing homes and extended care facilities is estimated to be as high as 80% of the patient population (AGS, 2002). However, levels of dementia may limit pain reporting in this group of patients. To facilitate the process, a group of pain assessment tools have been developed to use for assessing pain in the nonverbal patient. Behavioral scales for pain assessment is one of the newest and more challenging areas of pain assessment research; as such, the tools may not be as completely developed or refined as self-report scales that have been used for many years. Some of the tools are designed to be used for specific populations such as cognitively impaired patients or intubated, critically ill patients. These tools may be useful with critically ill, intubated patients, demented nursing home patients, or patients with aphasia from strokes who may be unable to communicate the extent of their pain. In order to use a behavioral scale, it is important to identify those behaviors that indicate pain. The original research in this area was to develop a list of behaviors that were indicative of pain, the Checklist of Nonverbal Pain Indicators (CNPI). From the studies comparing pain in cognitively intact patients and similar pain experiences in patients who were cognitively impaired, a list of six behaviors was developed that were determined to indicate the presence of pain (Feldt, 2000; Feldt et al., 1998). The six behaviors were identified as: ■ Vocalizations ■ Facial grimacing ■ Bracing ■ Rubbing ■ Restlessness ■ Vocal complaints (Feldt, 2000) Additional behaviors that were determined to be indicative of pain were listed in the AGS guidelines for treating persistent pain in older persons. These behaviors include: ■ Verbalizations: Moaning, calling out, asking for help, groaning ■ Facial expressions: Grimacing, frowning, wrinkled forehead, distorted expressions

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34 2. The Art and Science of Pain Assessment ■

Body movements: Rigid/tense body posture, guarding, rocking, fidgeting, pacing, massaging the painful area ■ Changes in interpersonal interactions: Aggression, combative behavior, resisting care, disruptive, withdrawn ■ Changes in activity patterns or routines: Refusing food, appetite changes, increase in rest or sleep, increased wandering ■ Mental status changes: Crying, tears, increased confusion, irritability, or distress (AGS, 2002) When attempting to assess pain in a nonverbal patient, the important elements are: ■ Attempt a self-report (a self-report can be valid, even in advanced dementia, with use of a “yes” or “no” question) ■ Search for the potential causes of pain ■ Observe patient behaviors ■ Use surrogate reporting by family or caregivers indicating pain and/or behavior/activity changes ■ Attempt an analgesic trial (Herr et al., 2006) In order to use behaviors to identify pain, tools have been developed that use the behaviors and that format the assessment in several different styles for use in different patient populations.

PAIN ASSESSMENT IN ADVANCED DEMENTIA PAINAD Persons with dementia are some of the most difficult patients to assess for pain, as many are nonverbal. The PAINAD (Figure 2.8) is a pain assessment tool created to assess pain in patients with advanced dementia and Alzheimer’s disease (Warden, Hurley, & Volicer, 2003). The PAINAD uses five behaviors common to patients with dementia who have pain: ■ Breathing ■ Negative vocalizations ■ Facial expression ■ Body language ■ Consolability To use the tool, the five behaviors are rated as: ■ 0—normal, no symptoms or pain behaviors ■ 1—occasional, slightly affected, such as occasional pacing, occasional moans ■ 2—positive behaviors, such as hyperventilation, body rigidity, repeated moaning, or striking out

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Pain Assessment in Advanced Dementia (PAINAD)

35

After determining the extent of the behaviors they are rated and a score is derived, providing a numeric rating for the pain. Using this tool can provide a more consistent approach to assessing pain in these patients. The tool has been found to be simple and easy to use in the clinical setting (Hutchinson, Tucker, Kim, & Gilder, 2006). It has also resulted in increased detection of pain (Hutchinson et al., 2006).

0 Breathing

Normal

1

2

Occasional labored Noisy, labored breathing, short breathing, long period of hyperperiod of hypervenventilation tilation, CheyneStokes respirations

Negative None Vocalization

Occasional moan/ groan, low-level speech/negative or disapproving quality

Repeated troubled calling out, loud moaning or groaning, crying

Facial Expression

Smiling

Sad, frightened, frowning

Facial grimacing, inexpressive

Body Language

Relaxed

Tense, distressed, Rigid, fists clenched, pacing, fidgeting knees pulled up. Pulling or pushing away, striking out

Consolability

No need to console

Distracted or reas- Unable to console, sured by voice or distract, or reassure touch

Total Score ___________ Source: Developed at the New England Geriatric Research Education and Clinical Center, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA. Warden, V., Hurley, A. C., & Volicer, L. (2003). Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) Scale. Journal of the American Medical Directors Association, 4, 9–15.

Figure 2.8 ■ PAINAD.

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36 2. The Art and Science of Pain Assessment Limitations include: The caregiver assesses for pain, and caregiver assessments may not correlate well with pain ■ Numeric conversion of observation can be questionable ■ Less comprehensive than needed for full assessment of pain (Herr et al., 2006) There are other tools that can be used in this patient population to assess pain, but the PAINAD has been used more widely. ■

PAYEN BEHAVIORAL PAIN SCALE BPS Item

Description

Facial Expression

Relaxed Partially tightened (brow lowering) Fully tightened (eyelid closing) Grimacing No movement Partially bent Fully bent with finger flexion Permanently retracted Tolerating movement Coughing but tolerating ventilation for most of the time Fighting ventilator Unable to control ventilator

Upper Limbs

Compliance With Ventilation

Score 1 2 3 4 1 2 3 4 1

2 3 4

Payen, J. F., Bru, O., Bosson, J. L., Lagrasta, A., Novel, E., Deschaux, I., Lavagne P., Jacquot, C. (2001). Assessing pain in critically ill sedated patients by using a behavioral pain scale. Critical Care Medicine, 29(12), 1–11. Used by permission of the authors.

Figure 2.9 ■ Behavioral Pain Scale (BPS).

Critically ill, intubated patients may not be able to self-report pain, especially if sedated. Many of the procedures that are performed on these patients are painful. In a large multisite study, Thunder II, pain ratings for a number of patient procedures were determined. Even so simple a task as turning a patient in bed can result in moderate-intensity pain (Puntillo et al., 2001).

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The Owestry Disability Index

37

When these patients have baseline chronic pain, the new pain the patient experiences is more significant and will result in higher intensity pain. To assess pain in these patients requires a tool that can detect pain behaviors, such as brow furrowing, and give an indication of pain intensity. The Payen BPS (Figure 2.9) is designed specifically for unresponsive critically ill intubated patients and includes a section that is designed to assess compliance with ventilation. The three assessment categories for this scale include: ■ Facial expression ■ Upper limb movement ■ Compliance with ventilation To score each category, a 4-point scale is used, ranging from 1—relaxed, no movement; to 4—the highest rating, indicating grimacing, retracted limbs, and unable to control ventilation. In the original validation study, 30 critically ill, intubated patients were divided into three groups based on sedation levels; mild, moderate, or heavy. Findings from the study indicate that in each of the groups there was a sufficient correlation with the NRS when a pain stimulus such as a turn in bed was performed (Payen et al., 2001; Purdum & D’Arcy, 2005). The effect of the sedation was apparent but there was still a fair correlation with the NRS, even in the group of heavily sedated patients. The tool is reliable and valid for assessing pain in this patient population. A replication study by Aissaoui et al. (2005) had similar results. There are other critical care pain assessment tools such as the Gelinas Critical Care Pain Observation Tool (CPOT) that use behavioral observation to estimate pain intensity (Gelinas, Fillion, Puntillo, Viens, & Fortier, 2006). Although these tools are not perfected, they do provide a means of assessing pain in patients who were once thought to be unassessable (Hutchinson et al., 2006).

MEASURES OF FUNCTIONALITY Because success with chronic pain treatment plans relies so heavily on functionality, it is important to get a baseline measure of functionality and continue to track progress throughout the treatment period. There are two measures that are used most often for both research and clinical practice: the Owestry Disability Index and the SF-36, or its shorter version the SF-12.

THE OWESTRY DISABILITY INDEX This tool is a reliable and valid measure of functionality. It was designed for use as a functional outcome measure for patients with low back pain. The tool consists of 10 sections with six questions per section that relate to

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38 2. The Art and Science of Pain Assessment pain intensity, ability to perform personal care, sleeping, sitting, and social life, to name a few. Each section has a series of questions that indicate how long the person can sustain the activity, such as sitting, medication use for pain relief, or level of activity, for example, traveling. The patient completes the assessment tool and selects the answer that most closely represents her pain or limitation within the last week or two. If two answers seem to fit the best response, the patient is instructed to select the answer with the highest point value for that question. Disability is calculated by taking the point total, dividing by 50, and multiplying by 100 to equal percent disability. After scoring, the tool disability is ranged from 0% indicating minimal disability and 100% indicating bedbound.

SF36 OR SF12 QUESTIONNAIRES The original form of the SF questionnaire was the 36-item survey that assessed eight domains of health, including physical functioning, bodily role limitation, and social functioning. It is a generic measure that determines the burden of disease for an individual patient. A shorter version of the SF-36, the SF- 12, uses 12 items taken from the original 36-question format. The shorter form still has the questions from the eight domains and it can reproduce the physical and mental health summary measures with at least 90% accuracy (IQOLA website, www.iqola.org/instruments, retrieved July 24, 2013). Using either of these tools allows the health care practitioner to screen individual patients, and assess health and relative burden of disease while differentiating the benefits of various treatment options.

ASSESSING PAIN IN SPECIALTY POPULATIONS There are some patient populations in which pain assessment is more difficult: children, older adults, and patients with a history of substance abuse. These patients have special needs and understanding when it comes to assessing pain, and there are some tools and concepts that are helpful for these groups of patients.

ASSESSING PAIN IN OLDER ADULTS Older patients have experienced pain before. They have any number of chronic pain conditions, such as osteoarthritis or angina, and comorbidities, such as chronic renal failure or atrial fibrillation on warfarin, that can

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Assessing Pain in Patients With a Substance Abuse History

39

make selecting pain medication difficult. In many cases, the older patient is reluctant to be perceived as a complainer and may fear adding costly pain medications to an already crowded medication regimen (Bruckenthal & D’Arcy, 2007). To get a good pain assessment in older patients, make sure that any assistive devices such as glasses and hearing aids are in place. Convey to the patient that you have an interest in her pain, would like to help relieve the pain, and have the time to talk with her. Educate the patient about pain assessment. Help the patient to understand that a good pain assessment is the best way to determine what medications and inter ventions could be helpful for pain relief. Include the family when it is appropriate.

ASSESSING PAIN IN PATIENTS WITH A SUBSTANCE ABUSE HISTORY Illicit substance abuse and prescription drug abuse and misuse has been steadily increasing at an alarming rate. Patients who have a history of substance abuse are difficult to assess for pain, as they often will report continued levels of high-intensity pain despite efforts to control the pain. It can be very frustrating for a nurse to give large doses of pain medication to these patients and have the patient continue to report high-intensity pain. Some of this response is related to alterations in the patient’s physiology that are created with continued use of opioid medications or illicit substances, which cause the patient’s body to become more sensitive to pain. This heightened sensitivity to pain is called opioid-induced hyperalgesia, and it can occur as soon as 1 month after opioid use/abuse begins (Chu et al., 2006). It would then be expected that these patients would report higher pain levels and require more pain medication to control their pain. To perform a pain assessment in a patient who is actively using illicit substances or has a history of substance abuse, it is important to remember that: ■ A nonjudgmental approach is best. In order to get accurate information, the patient should feel that she can trust you with the information and will not be judged ■ Determine when the patient last used an illicit substance ■ Determine what the substance is and how much the patient uses every day ■ Assess for any cosubstance abuse, such as combinations of alcohol, heroin, marijuana, cocaine, and so on ■ Reassure the patient that you need this information to help determine what types of medication or interventions will help to control the pain

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40 2. The Art and Science of Pain Assessment ■ ■

Reassess the patient pain at regular intervals to determine if the pain medication has been effective in reducing pain Remember that these patients may have had bad experiences with other health care providers and try to gain trust so that the patient feels comfortable talking to you about her pain

BARRIERS TO PAIN ASSESSMENT There are some barriers that make accurate pain assessment challenging for nurses: ■ Bias ■ Cultural influences ■ Family values ■ Belief systems (Harrison, 1991) Research indicates that nurses still have difficulty accepting a patient’s report of pain as valid and credible (Berry et al., 2006; D’Arcy, 2008, 2009; Drayer et al., 1999; Donovan et al., 1987; Grossman et al., 1991; Paice et al., 1991). In order to minimize the effects of these factors on pain assessment, it is important for the nurse to recognize these factors and consciously work to derive as accurate a pain assessment as possible. Today’s nurses are being held accountable for the quality of their pain management, including assessment. It is incumbent on each nurse who performs a pain assessment to attempt to get as accurate a pain assessment as possible. When pain assessment is poorly done it can affect the patient’s plan of care and adversely impact outcomes. Focusing on pain relief as the primary end to the assessment process and treatment selection will help control fears and bias that can negatively affect patient care. Accepting and believing the patient’s report of pain is essential to performing a good pain assessment. Using a recognized, reliable, and valid pain assessment tool; believing the patient; and accepting the patient’s report of pain in a nonjudgmental fashion will provide the patient with the best chance for adequate pain relief.

Case Study Rita J. is a 24-year-old patient who keeps complaining of pain “all over.” She relates that the pain in her shoulders, hips, and knee makes it impossible for her to work long periods of time. She has some tingling in her feet but it never gets so bad that it is worse than her usual pain. On her best days, Rita reports that the pain is a 4 out of 10,

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References

41

but on her worst days she describes it as 9 out of 10. She has gone to physicians specializing in joint pain but finds they treat her as if her pain is not that important, and give her the impression that they feel she could do better if she wanted to. The last time she saw a health care provider she was asked to see a psychologist. She reports that her sleep is never very good, she is awake most nights, and subsequently feels very fatigued all the time. She tells you she is reluctant to talk about her pain anymore, but it still makes her feel miserable and it limits her ability to work and support herself.

Questions to Consider 1. What is the best tool to use to assess the pain Rita is having? 2. Rita is diagnosed with fibromyalgia, a centrally mediated pain syndrome. Which clues in her description would lead you to her diagnosis? 3. What are the indicators that some of her pain is neuropathic? 4. What would the advantage be of using the BPIQ for assessing Rita’s pain? 5. What elements of Rita’s description of her past health care provider experience influence her ability to provide a good pain history? 6. As her health care provider, what one statement could you make to Rita to help develop a therapeutic relationship with her?

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42 2. The Art and Science of Pain Assessment Pharmaceutical Council and The Joint Commission on Accreditation of Healthcare Organizations. Bruckenthal, P., & D’Arcy, Y. (2007). Assessment and management of pain in older adults: A review of the basics. Topics in Advanced Practice Nursing ejournal 2007 (1). Retrieved September 17, 2009, from http://www.medscape.com/viewarticle/556382 Chok, B. (1998). An overview of the visual analogue scale and McGill pain questionnaire. Physiotherapy Singapore, 1(3), 88–93. Chu, L., Clark, D., & Angst, M. (2006). Opioid tolerance and hyperalgesia in chronic pain patients after one month of oral morphine therapy: A preliminary prospective study. The Journal of Pain, 7(1), 43–48. Dahl, J. B., & Kehlet, H. (2006). Postoperative pain and its management. In S. B. McMahon & M. Kolzenburg (Eds.), Wall & Melzack’s textbook of pain (5th ed.). Philadelphia, PA: Churchill Livingstone. D’Arcy, Y. (2007). Pain management: Evidence-based tools and techniques for nursing professionals. Marblehead, MA: HCPro. D’Arcy, Y. (2008). Nursing 2008 pain management survey report. Nursing, 38 (6), 42–49. D’Arcy, Y. (2009). Be in the know about pain management. Results of the pain management survey. Nurse Practitioner Journal, 34(4), 43–47. D’Arcy, Y. (2011a). Compact clinical guide to chronic pain management. New York, NY: Springer Publishing Company. D’Arcy, Y. (2011b, December). Breakthrough pain in cancer. Pain Medicine News. Daut, R. L., Cleeland, C. S., & Flannery, R. (1983). Development of the Wisconsin brief pain questionnaire to assess pain in cancer or other diseases. Pain, 17, 197–210. Donovan, M., Dillon, P., & McGuire, L. (1987). Incidence and characteristics of pain in a sample of medical-surgical inpatients. Pain, 30(1), 69–78. Drayer, R., Henderson, J., & Reidenberg, M. (1999). Barriers to better pain control for hospitalized patients. Journal of Pain and Symptom Management, 17(6), 434–440. Farrar, J. T., Young, J. P., Lamoreaux, L., Werth, J. L., & Poole, R. M. (2001). Clinical importance of changes in chronic pain intensity measured on an 11 point numerical pain rating scale. Pain, 94, 149–158. Feldt, K. S. (2000). The checklist of non-verbal pain indicators (CNPI). Pain Management Nursing, 1(1), 13–21. Feldt, K. S., Ryden, M. B., & Miles, S. (1998). Treatment of pain in cognitively impaired compared with cognitively intact older patients with hip fractures. Journal of the American Geriatrics Society, 46 , 1079–1085. Gelinas, C., Fillion, L., Puntillo, K., Viens, C., & Fortier, M. (2006). Validation of the critical care pain observation tool in adult patients. American Journal of Critical Care, 15(4), 420–427. Ger, L., Ho, S., Sun, W., Wang, M., & Cleeland, C. (1999). Validation of the brief pain inventory in a Taiwanese population. Journal of Pain and Symptom Management, 18 (5), 316–322. Gordon, D., Pellino, T., Miaskowski, C., McNeill, J. A., Paice, J., Laferriere, D., & Bookbinder, M. (2002). A 10-year review of quality improvement monitoring in pain management: Recommendations for standardized outcome measures. Pain Management Nursing, 3 (4), 116–130.

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Gracely, R. H., & Dubner, R. (1987). Reliability and validity of verbal descriptor scales of painfulness, Pain, 29, 175–185. Graham, C., Bond, S., Gerkovich, M., & Cook, M. (1980). Use of the McGill questionnaire in the assessment of cancer pain: Replicability and consistency. Pain, 8, 377–387. Grossman, S., Sheidler, V., Sweeden, K., Mucenski, J., & Piantadosi, S. (1991). Correlation of patient and caregiver ratings of cancer pain. Journal of Pain and Symptom Management, 6(2), 53–57. Harrison, A. (1991). Assessing patient’s pain: Identifying reasons for error. Journal of Advanced Nursing, 16, 1018–1025. Huchinson, R., Tucker, W., Kim, S., & Gilder, R. (2006). Evaluation of a behavioral assessment tool for the individual unable to self-report pain. American Journal of Hospice and Palliative Medicine, 23 (4), 328–331. Herr, K., Bjoro, K., & Decker, S. (2006a). Tools for assessment of pain in nonverbal older adults with dementia: A state-of-the-science review. Journal of Pain and Symptom Management, 31(2), 170–192. Herr, K., Coyne, P., Key, T., Manworren, R., McCaffery, M., Merkel, S., … Wild, L. (2006b). Pain assessment in the nonverbal patient: Position statement with clinical practice recommendations. Pain Management Nursing, 7(2), 44–52. Herr, K., & Garand, L. (2001). Assessment and measurement of pain in older adults. Clinics in Geriatric Medicine, 17(4), 1–22. Herr, K. A., & Mobily, P. (1993). Comparison of selected pain assessment tools for use with the elderly. Applied Nursing Research, 6(1), 39–46. International Quality of Life Assessment. IOQLA. Retrieved from http://www.ioqol.org/ instruments. Last accessed 7/24/2013. Jensen, M. P. (2003). The reliability and validity of pain measures in adults with cancer. Journal of Pain, 4(1), 2–12. Jensen, S. (2011). Nursing health assessment: A best practices approach. New York, NY: Lippincott Williams & Wilkins. Joint Commission on Accreditation of Healthcare Organizations. (2000). Pain assessment and management: An organizational approach. Oakbrook Terrace, IL: Author. Klepstad, P., Loge, J. H., Brchgrevink, P. C., Mendoza, T. R., Cleeland, C., & Kaasa, S. (2002). The Norwegian brief pain inventory questionnaire: Translation and validation in cancer pain patients. Journal of Pain and Symptom Management, 2495, 517–525. MacIntyre, D. L., Hopkins, P. M., & Harris, S. R. (1995). Evaluation of pain and functional activity in patellofemoral pain syndrome: Reliability and validity of two assessment tools. Physiotherapy of Canada , 47(3), 164–170. McDonald, D. D., & Weiskopf, C. S. (2001). Adult patients’ postoperative pain descriptions and responses to the short form McGill Pain Questionnaire. Clinical Nursing Research, 10 (4), 442–452. Melzack, R. (1975). The McGill pain questionnaire: Major properties and scoring methods. Pain, 1, 277–299. Melzack, R. (1987). The short form McGill pain questionnaire. Pain, 30, 191–197. Mystakidou, K., Mendoza, T., Tsilika, E., Befon, S., Parpa, E., Bellos G., . . . Cleeland, C. (2001). Greek brief pain inventory: Validation and utility in cancer pain. Oncology, 60 (1), 35–42.

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44 2. The Art and Science of Pain Assessment Mystakidou, K., Parpa, E., Tsilika, E., Kalaidopoulou, O., Georgaki, S., Galanos, S., & Vlahos, L. (2002). Greek McGill pain questionnaire: Validity and utility in cancer patients. Journal of Pain and Symptom Management, 24(4), 370–387. Paice, J., Mahon, S., & Faut-Callahan, M. (1991). Factors associated with adequate pain control in hospitalized postsurgical patients diagnosed with cancer. Cancer Nursing, 14(6), 298–305. Payen, J. F., Bru, O., Bosson, J. L ., Lagrasta, A ., Novel, E ., Deschaux, I., & Jacquot, C. (2001). Assessing pain in critically ill sedated patients by using a behavioral pain scale. Critical Care Medicine, 29 (12), 1–11. Puntillo, K., White, C., Morris, A., Purdue, S., Stanik-Hutt, J., Thompson, C., & Wild, L. (2001). Patients’ perceptions and responses to procedural pain: Results of the Thunder II project. American Journal of Critical Care, 10(4), 238–251. Purdum, A., & D’Arcy, Y. (2005). A comparison of two behavioral pain scales with intubated intensive care (ICU) patients. San Antonio, TX: American Pain Society. Radbruch, L., Liock, G., Kiencke, P., Lindena, G., Sabatowski, R., Grond, S., . . . Cleeland, C. (1999). Validation of the German version of the brief pain inventory. Journal of Pain and Symptom Management, 18 (3), 180–187. Raiche, K., Osborne, T., Jensen, M. P., & Cardenas, D. (2006). The reliability and validity of pain interference measures in persons with spinal cord injury. Journal of Pain, 7(3), 170–186. Tan, G., Jensen, M. P., Thornby, J., & Shanti, B. (2004). Validation of the brief pain inventory for chronic non-malignant pain. Journal of Pain and Symptom Management, 5(2), 133–137. Tang, N. K ., & Crane, C . (2006). Suicidality in chronic pain: A review of the prevalence, risk factors and psychological links. Psychological Medicine, 36(5), 575–586. Tittle, M. B., McMillan, S., & Hagan, S. (2003). Validating the brief pain inventory for use with surgical patients with cacner. Oncology Nursing Forum, 30 (2), 325–330. Warden, V., Hurley, A. C., & Volicer, L. (2003). Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) Scale. Journal of the American Medical Directors Association, 4, 9–15. Weiner, D. K., Herr, K., & Rudy, T. (2002). Persistent pain in older adults: An interdisciplinary guide for treatment. New York, NY: Springer Publishing Company. Wilkie, D., Savedra, M., Holzmer, W., Tesler, M., & Paul, S. (1990). Use of the McGill pain questionnaire to measure pain: A meta-analysis. Nursing Research, 39 (1), 36–41. Williams, V. S., Smith, M., & Fehnel, S. (2006). The validity and utility of the BPI interference measures for evaluating the impact of osteoarthritis pain. Journal of Pain and Symptom Management, 31(1), 48–57.

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SECTION II: COMMON MEDICATIONS AND TREATMENT OPTIONS FOR PAIN MANAGEMENT

3 Nonopioid Medications

Drug treatment is the mainstay of pain management (World Health Organization [WHO], 1996). Most patients who go to a health care provider for pain management expect to come away with a prescription for a medication to treat the pain. In the past, many patients expected opioids to be the choice of the prescriber, but in today’s climate of conservative prescribing and an awareness of potential prescription drug abuse, nonopioid medications are becoming more common. There are also a large number of nonopioid pain relief medications available for purchase over the counter (OTC). Before they seek help for pain management, patients may try to self-treat the pain with any one of the wide variety of OTC pain-relief medications such as acetaminophen or ibuprofen. However, these medications are seen by patients as less potent than medications that need a prescription. Some nonopioid medications such as ketorolac (Toradol), an intravenous nonsteroidal anti-inflammatory drug (NSAID) commonly used for postoperative pain relief, has the potential for significant additive pain relief, but there are concerns for breastfeeding women. Since some medications can cross the placental barrier prior to birth or be secreted in breast milk, there are special considerations for medications such as Toradol (discussed later in this chapter). In a Cochrane review with 19 studies and 2,863 women, opioids were found to provide superior pain relief for labor pain, while nonopioid medications were found to be superior to placebo (Othman, Jones, & Neilson, 2012). Overall, the findings did not support the use of nonopioid medications alone to treat the pain of childbirth (Othman et al., 2012). These findings show that nonopioid medications such as NSAIDs may have a specific type of pain, such as inflammatory pain, where they are most effective. For some conditions such as acute low back pain, the current recommendation by national pain societies is acetaminophen/NSAIDs

45

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46 3. Nonopioid Medications and continued activity, rather than opioids and bedrest (Chou et al., 2009). About 15% of the patients who have acute low back pain progress to chronic low back pain. This is when medication management is recommended and a plan of care that includes medications along with other therapies such as physical therapy and counseling is developed (D’Arcy, 2009c). Opioids currently are reserved in most cases for severe pain that is impairing functionality (Chou et al., 2008). This change in thinking may frustrate some patients who think that the correct treatment for their acute low back pain is bedrest with opioids for pain relief. To treat pain with any medication requires a pain assessment, history and physical, examination, and medication review that includes OTC medications, herbal supplements, and vitamins (WHO, 1996). Some patients who have been treated with pain medications have information and personal experience with opioids or nonopioid medications. When patients have information about medications that are effective for relieving their pain, consider this to be information that is similar to what diabetics provide about their daily insulin doses to a new health care provider. Clinical Pearl

B eware of ”labeling” a pa ent as a drug seeker just because she can provide informa on on what medica on works best for her or knows specifi c doses.

There are genetic factors that influence the effectiveness of pain medications in a specific individual, so when a patient says, “the only medication that works for me is morphine,” it may really be a reflection of how her genetic make-up has reacted to medications tried in the past. The patient should never be penalized or labeled for providing information on how specific medications have worked in the past. In fact, this information may just be the best clue about how to effectively manage the patient’s pain. This section of the book will provide information about using pain medications of various types—NSAIDs, opioids, and other coanalgesics such as antidepressants. The information will be taken from current guidelines developed by the American Pain Society (APS), the American Geriatrics Society (AGS), the WHO, the American Academy of Pain Medicine (AAPM), and other national organizations. The topics of addiction, dependency, and tolerance will be discussed in other chapters. Information on integrative therapies that can be combined with medication management will be provided in Chapter 6.

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General Guidelines

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GENERAL GUIDELINES All patients have the right to have their pain treated, and most health care providers make honest efforts at getting the patient’s pain to a tolerable level (Brennan, Carr, & Cousins, 2007). Most chronic patients with acute or surgical pain realize that “pain-free” is not a reasonable goal to set and that a risk-benefit analysis is used to determine what type of medication management will provide the best outcome for the patient. Combining nonopioid medications, opioid analgesics, and coanalgesics in conjunction with interventional treatments may make dealing with pain a more intensive endeavor, but it will provide better outcomes in the long run. Most prescribers have very little concern when opioids are needed for short-term pain management, but when opioid therapy is required long term, their concern increases and fears of addicting the patient or fear of increased regulatory oversight can affect the prescriber’s willingness to continue providing opioid medications to the patient with chronic pain (D’Arcy, 2009a). For acute pain, this issue is not as significant, but there are still some health care providers who feel that they are contributing to addiction when opioids are used in the acute care setting. This can lead the prescriber to consider the nonopioid medications as a first-line treatment when an opioid may be indicated. Alternatively, the prescriber may try an opioid that he or she perceives as having a lower potential for abuse or addiction, such as acetaminophen with codeine, even though the patient may be reporting severe pain. Selecting a medication that will be effective for the patient’s pain complaint can be trial and error until the right medication and dose are found. Some patients who have acute pain will progress to chronic pain management. All patients who are being considered for chronic opioid therapy (COT) should be screened for risks, including opioid misuse, development of aberrant medication-taking behaviors, and addiction (Chou et al., 2008). The development of a comprehensive treatment plan that includes the use of various medications is extremely important to the success of pain management (Institute for Clinical Symptoms Improvement [ICSI], 2008). If long-term opioids are being considered, an opioid agreement may be created that outlines when the medications will be refilled, the risks and benefits of the medications, the use of random urine screens, and the consequences of violating the agreement (Trescot et al., 2008). A sample opioid agreement can be obtained at the website of the American Academy of Pain Medicine or www.painedu.org, a pain management website. At the other end of the spectrum, the undertreatment of pain can produce a plethora of unwanted side effects, especially with older patients. Some of the significant consequences of undertreated pain include:

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48 3. Nonopioid Medications ■ ■ ■ ■ ■ ■ ■ ■ ■

Depression Impaired cognition Sleep disturbances Poorer clinical outcome Decreased functional ability Decreased quality of life Anxiety Decreased socialization Increased health care utilization and costs (AGS, 2002; Brennan et al., 2007; D’Arcy, 2007; Karani, 2004) In a recent survey conducted by Stanford University, 40% of the respondents in the survey reported that chronic pain interfered with enjoyment of life and pleasurable activities, plus chronic pain adversely affected their mood (Stanos, Fishbain, & Fishman, 2009). Although 63% of the survey respondents indicated that they had gone to their health care provider while in pain, only 31% of the patients reported that they had either complete or a great deal of pain relief, with less than 50% reporting a lot of control over their pain. What this tells us about pain that progresses to chronic pain and its management is that the problem is very big and the health care provider’s ability to control the pain is limited. Among pain specialists, there is currently a movement toward considering chronic pain as a disease in and of itself (Brennan et al., 2007). There is also evidence to support the idea that untreated or undertreated acute pain can lead to more difficult-to-treat chronic pain syndromes. The effect of chronic pain on the patient is so profound that it constitutes a major threat to health and wellness. Unrelieved chronic pain can affect many different physiologic systems. This includes: ■ Reduced mobility ■ Loss of strength ■ Disturbed sleep ■ Decreased immune function ■ Increased susceptibility to disease ■ Dependence on medications for pain relief ■ Depression and anxiety (Brennan et al., 2007) Because of the magnitude of the problem of pain and the impact on the individual patient’s well-being, health care providers need to become proficient in prescribing and dosing medications for pain of all types. It is distressing for the patient who finds himself or herself in daily chronic pain after surgery, injury, or chronic disease progression. The WHO developed an analgesic ladder that can provide guidance to prescribers about their choices of pain medications (Figure 3.1). Although the ladder was originally developed for cancer pain, it has been adapted for use in many areas of pain management to include acute pain.

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Level II Medications: Moderate to Severe Pain: Pain Intensity 4–6

49

WHO Step Approach to Cancer Pain Severe Pain

3 2 1

Strong opioid ± nonopioid

± Adjuvant

Moderate to Severe Pain Weak opioid and/or nonopioid analgesia • Codeine • Tramadol

± Adjuvant

Mild to Moderate Pain Nonopioid analgesia • Acetaminophen • COX-2 Inhibitors • NSAIDs

± Adjuvant

Figure 3.1 ■ Analgesic ladder.

LEVEL I MEDICATIONS: MILD TO MODERATE PAIN: PAIN INTENSITY 13 Medications on the first step of the ladder, mild to moderate pain, include acetaminophen; NSAIDs, both selective and nonselective; and adjuvant medications, or coanalgesics. These adjuvant and coanalgesic medications can add to pain relief although they are not primarily classed as pain medications. These medications include antidepressants, anticonvulsants, muscle relaxants, and topical medications.

LEVEL II MEDICATIONS: MODERATE TO SEVERE PAIN: PAIN INTENSITY 46 Moderate to severe pain medications such as opioid-combination medications, including hydrocodone or oxycodone and acetaminophen, are located on the middle step of the ladder. Tramadol and tapentadol, mixed mu agonists, and selective serotonin reuptake inhibitors (SSRIs) are also included in this level of medications for moderate pain. Adjuvant medications for this level could include muscle relaxants and antidepressants of the lower level, but acetaminophen or NSAIDs of the lower level could also be continued at this point for additional pain relief.

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50 3. Nonopioid Medications

LEVEL III MEDICATIONS: SEVERE PAIN: PAIN INTENSITY 710 Patients who are reporting severe pain require strong opioid medications for pain relief. Included in this group are opioids such as morphine, fentanyl, hydromorphone, and methadone. As with the other steps, adjuvant medication should be continued here to help reduce opioid needs and provide additional pain relief. Clinical Pearl

Although the analgesic ladder provides some guidance with the choice of medica ons, the overall assessment, source of the pain, and physical history, including comorbidi es and o rgan func ons, need to be considered when selec ng a medica on for pain (Adapted from D’Arcy, 2007).

It is important to remember that the patient’s report of pain is more than a number. Using the numeric rating scale to determine pain intensity only provides information on a single component of the pain experience. This type of pain intensity rating can be used to determine the efficacy of a medication or intervention so that the plan of care can be adjusted accordingly. It does not provide any information on the effect of the pain on the patient’s functioning or psychological impact. There are many pieces of the patient puzzle that need to fit together just right to find an effective method for pain relief. Although the severity ratings of the analgesic ladder are a guide to choosing the correct medication, because there is a group of medications in each level, the practitioners can individualize the medication selection. The efficacy of the medication is an individualized response based on the patient’s report of decreased pain or increased functionality (D’Arcy, 2007).

NONOPIOID ANALGESICS FOR PAIN ACETAMINOPHEN AND NSAIDs Although acetaminophen and NSAIDs are considered to be weaker medications for pain, they can provide a good baseline of relief that can help decrease the amount of opioid required to treat pain. Many women are used to taking these medications for headache or menstrual pain relief. Both acetaminophen and NSAID medications are seriously overlooked and underutilized as coanalgesics when higher intensity pain is reported. Multimodal analgesia, which is recommended for complex pain needs and for postoperative pain relief, may consist of any combination of medications that may include the use of acetaminophen and NSAIDs.

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Acetaminophen (Acetyl-Para-Aminophenol [APAP], Paracetamol)

51

However, there are some important considerations when adding these medications into a pain regimen. These medications are not benign and have risk potential for adverse effects that should be considered prior to use in all patients. Patients may have coagulopathies that make the use of NSAIDs difficult. These types of medications also have maximum dose levels that create a ceiling and limit dose escalations.

ACETAMINOPHEN ACETYLPARAAMINOPHENOL APAP, PARACETAMOL Acetaminophen is used the world over to treat pain. Known as paracetamol in Europe, it is associated with the Tylenol brand in the United States and is widely added to many OTC pain relievers such as Excedrin, Midol, and the various Tylenol products. It is available as tablets, gel caps, elixirs, and as pediatric formulations. The newest Food and Drug Administration (FDA)-approved form is intravenous acetaminophen provided as an infusion called Ofirmev. It is dosed as 1,000 mg every 6 to 8 hours. This is helpful for patients who cannot take oral medications, postoperative patients, or patients with resistant nausea and vomiting. Most home medicine chests have some type of acetaminophen compound that the family uses for relief of minor aches and pains. Because it is so popular and easy to obtain, some 24.6 billion doses were sold in 2008 (Pan, 2009). Acetaminophen is classed as a para-acetaminophen derivative (Nursing 2014 Drug Handbook, 2014) and it has a similar pain relief profile to aspirin without the potential to damage the gastric mucosa (APS, 2008). Pain relief is superior to placebo, but slightly less than NSAIDs (APS, 2008). The action of the medication is thought to be inhibition of prostaglandins and other pain-producing substances (Nursing 2014 Drug Handbook, 2014). It is entirely metabolized in the liver and can cause blood pressure elevations (Buvenendran & Lipman, 2010). Advantages of acetaminophen over NSAIDs include: ■ Fewer GI adverse effects ■ Fewer GI complications In general, acetaminophen is safe and effective when used according to the directions and labeling on OTC preparations and any prescriptionstrength medication information. There are serious concerns today about acetaminophen overdose, intentional and unintentional. Because of these concerns, the FDA has been holding hearings and is considering reducing the recommendations for the daily total dose from 4,000 mg per day to a lower limit. They are also considering making the 500 mgstrength tablets, currently available OTC, prescription only and limiting the number of doses in each package (Alazraki, 2009).

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52 3. Nonopioid Medications Clinical Pearl

Pa ents need to be aware of the total daily doses they are inges ng from all combina on medica ons, such as hydrocodone and acetaminophen, when Tylenol is also being used as a coanalgesic.

The concerns underlying these fears are related to some very serious statistics about the increase in liver disease related to acetaminophen use. There is a clear connection between acetaminophen overuse and liver disease and failure. Total acetaminophen doses should not exceed 4,000 mg per day, including any combination medication being taken by the patient that may include acetaminophen (ASIPP, 2008). Even at this dose there is an associated risk of hepatotoxicity (APS, 2008). From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States (Alzaraki, 2009). Between 1990 and 1998, there were 56,000 emergency department visits, 26,000 hospitalizations, and 458 deaths reportedly connected to acetaminophen overdoses (Alazraki, 2009). Many of these overdoses were unintentional and caused by a knowledge deficit about the “hidden” acetaminophen found in combination medications. Some of the most common prescription-strength combinations with acetaminophen include: ■ Tylenol #3 ■ Vicodin ■ Percocet ■ Ultracet Other OTC medications that can contain hidden acetaminophen include: ■ Alka-Seltzer Plus ■ Cough syrups such as NyQuil/DayQuil cold and flu relief ■ OTC pain relievers such as Pamprin and Midol maximum-strength menstrual formula Care should be taken with older patients, patients with liver dysfunction, and any patient who consumes alcohol regularly (AGS, 2009; APS, 2008). In these cases, acetaminophen doses should not exceed 2,000 mg/day or it should not be used at all (AGS, 2009). The risk of liver failure is very real. It is imperative for all patients who are taking Tylenol products to read and understand the medication administration guidelines and recommendations. Exceeding daily recommended doses of acetaminophen can have deadly consequences. One little-known effect is the effect of acetaminophen on the anticoagulant warfarin. Careful monitoring of anticoagulation should take place when a patient is taking both acetaminophen and warfarin, since acetaminophen is an underrecognized cause of overanticoagulation when both medications are being used concomitantly (APS, 2008).

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The NSAID Debate

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ASPIRIN ASA ASA is one of the oldest pain relievers known to man. It is classed as a salicylate (Nursing 2014 Drug Handbook, 2014). Before the beginning of modern medicine, salicylate-rich willow bark was used as one of the earliest forms of pain relief. Most Americans use ASA for minor aches and pains, and because of its action on platelet activity it has been promoted for early in-the-field treatment for patients who are experiencing a heart attack. It was traditionally used for pain relief of osteoarthritis, rheumatoid arthritis, and for other inflammatory conditions, but has been replaced by other newer NSAIDs (APS, 2008; Nursing 2014 Drug Handbook, 2014). ASA is available in many different doses, but the most common dose is 500 to 1,000 mg every 4 or 6 hours, with a maximum dose of 4,000 mg per day (APS, 2008). It is available as buffered, sustained-release, and chewable formulations. Despite its easy availability and widespread use, there are some serious adverse events connected with regular ASA use. These include: ■ GI distress ■ GI ulceration and bleeding ■ Prolonged bleeding times ■ Reye syndrome ■ ASA hypersensitivity These reactions to ASA are quite serious and in some cases life-threatening. GI ulceration and bleeding can cause death. ASA is not recommended for children under the age of 12 due to the potential for Reye syndrome, which can develop when a child has a viral illness and ASA is given for pain relief (APS, 2008). ASA hypersensitivity reactions can be minor or very severe. A minor reaction presents as a respiratory reaction with rhinitis, asthma, or nasal polyps. A smaller group of patients can get more serious reactions that include: ■ Urticaria ■ Wheals ■ Angioneurotic edema ■ Hypotension ■ Shock and syncope (APS, 2008) Although ASA seems like a very simple analgesic, care should be taken with any ASA use.

THE NSAID DEBATE NSAIDs of all types are commonly used for pain that is mild to moderate in intensity (Exhibit 3.1). They can be used for inflammatory pain, as an analgesic for low-level pain, or as a coanalgesic. They are available in many different combinations in both prescription strength and OTC preparations.

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54 3. Nonopioid Medications One of the newest ways to use NSAIDs is via the topical formulations that can be used at the site of the pain. This method significantly reduces the potential for gastric adverse events. Oral NSAIDs have a maximum dose that limits dose escalation beyond the maximum dose ceiling. Exhibit 3.1

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

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The NSAID Debate

Exhibit 3.1

55

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (continued)

NSAIDs have two different types of actions, selective and nonselective. Nonselective NSAIDs affect all types of prostaglandins found in the stomach, kidneys, heart, and other organs of the body ■ Selective NSAIDs protect the prostaglandins that coat the stomach lining but do affect the other types of prostaglandins found elsewhere in the body The most common use of NSAIDs is to treat pain that is caused by inflammation such as arthritis or common musculoskeletal injuries (APS, 2008; D’Arcy, 2007). ■

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56 3. Nonopioid Medications NSAIDs have long been a standard for pain relief in older patients. Relatively cheap, they are easily accessible at most supermarkets or drug stores. They are available as OTC formulations and in prescription strength as well. The most common use is for arthritis pain, headaches, or minor sprains and strains. There are two basic classes of NSAIDs, nonselective and selective NSAIDs (COX-2 selective medications). The nonselective NSAIDs such as ibuprofen (Motrin, Advil), naproxen (Naprosyn), and ketoprofen (Orudis) affect production of the prostaglandins that coat and protect the lining of the stomach and other organs of the body such as the kidneys and the heart. The only COX-2 medications available at this time are celecoxib (Celebrex) and meloxicam (Mobic), which spares the stomach prostaglandins and does not affect platelet aggregation, so blood clotting is not affected. Research from the FDA and the American Heart Association (AHA) indicates that all NSAIDs, not only the COX-2 selective medications such as Celebrex, have the potential for increased cardiovascular risk, renovascular risk, stroke, and myocardial infarction (Bennett et al., 2005). GI bleeding with NSAIDs continues to be a significant risk, and for those patients who are taking ASA as a cardiac prophylaxis, the risk increases several-fold with concomitant NSAID and ASA use (D’Arcy, 2007)

GI Risks With NSAIDs One of the major risks with nonselective NSAIDs is gastric ulceration. Gastric ulcers develop within a week in about 30% of patients started on nonselective NSAIDs (Wallace & Staats, 2005). Most patients with these ulcers are asymptomatic and only seek medical care when the bleeding becomes obvious with tarry stools or hematemesis. In an effort to lessen the risk of GI bleeding, some practitioners use a proton pump inhibitor (PPI) such as omeprazole (Prilosec), which only provides protection for the upper GI system. Patient adherence to taking a PPI for protection is also suspect. A recent study found that by the time the patients received three prescriptions for a PPI as NSAID prophylaxis, the nonadherence rate for patients with PPIs was high, at 60.8% (Sturkenboom, 2003). Since many older patients are also using ASA daily for cardioprotective effect, adding the incidence of ulcer formation with ASA to the NSAID risk only increases the potential for GI bleeding. Higher doses and older age are associated with a higher incidence of GI side effects (Perez-Gutthann, 1997). Additionally, chronic alcohol use with NSAIDs increases the risk for GI bleeding and ulceration. Whether GI issues are a consideration depends largely on the individual patient’s history and medical situation.

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Special Considerations for Ketorolac (Toradol)

57

Cardiovascular Risks With NSAIDs There are certain patient groups at higher risk for cardiovascular events and for whom NSAIDs are not recommended, including those patients who have had recent heart bypass surgery, patients with heart disease, and patients who have had transient ischemic attacks (TIAs) or strokes. In a sample of chronic NSAID users (n = 882) and intermittent users (n = 7,286) in hypertensive patients with coronary artery disease, NSAID use was associated with an increased risk of adverse events such as cardiovascular mortality (Bavry et al., 2011). For patients with multiple cardiac risk factors in a study of 23,728 patients, no association was found between NSAID use and myocardial infarction, cardiovascular death, or stroke, but there was an increased risk profile for patients with stable atherothrombosis (Barthelemy et al., 2011). For these at-risk patients, an alternate form of analgesic is recommended. When trying to determine which NSAID to offer a patient, consider that there are indications that naproxen interferes with the inhibitory effect of ASA (Capone et al., 2005), and the same effect may be seen with concomitant use of ibuprofen, acetaminophen, and diclofenac (Catella-Lawson, 2001). Overall, for patients taking ASA as a prophylactic there is an increased risk for GI events, and using NSAIDs may decrease the effectiveness of the ASA. In general, the recommendations for using NSAIDs for pain relief indicate that the medication should be used at the lowest dose for the shortest period of time (Bennett et al., 2005). That being the case, older patients should be aware that continuing to take NSAIDs long term for arthritis or other chronic conditions could cause serious, life-threatening effects.

SPECIAL CONSIDERATIONS FOR KETOROLAC TORADOL As a nonopioid, ketorolac (Toradol) has special appeal when patients presents with mild to moderate pain. It has been reported to provide similar analgesia as morphine or meperidine and it has a significant opioid-sparing effect (He & Hersch, 2012; Moodie, Brown, Bisley, Weber, & Bynum, 2008). Toradol is the only NSAID medication that can be given intravenously or intramuscularly. There is also an oral form of the medication that is less commonly used. A new nasal form of the medication was recently introduced, called SPRIX (He & Hersh, 2012). Toradol is a true NSAID that is classed as a cyclo-oxygenase inhibitor for both COX-1 and COX-2, so it is classed as a nonselective NSAID. Cyclo-oxygenase is an enzyme that metabolizes arachidonic acid to prostaglandins, prostacyclin, and thromboxanes (He & Hersch, 2012). Prostaglandins are found in many organs of the body, including the

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58 3. Nonopioid Medications heart, kidney, and stomach, and inhibition of these substances can cause life-threatening adverse events such as GI bleeding, myocardial infarction, or stroke. Although the anti-inflammatory effect of Toradol is highly analgesic, a risk-benefit analysis should be performed before the medication is used for a patient. Since the medication is cleared through the renal system it is not recommended for patients with elevated creatinine or kidney dysfunction. Doses of Toradol range from 15 to 30 mg IV every 6 hours, to be used for no more than 5 days. After day 1, when 150 mg can be given, the maximum daily dose is 120 mg (APS, 2008). Intranasal SPRIX (ketorolac tromethamine) is dosed as one spray (15.75 mg) to each nostril every 6 to 8 hours, with a maximum dose of 126 mg per day. Both forms of the NSAID need to have reductions in doses for small or elderly patients (APS, 2008). Unfortunately, even though it is more convenient and SPRIX provides excellent analgesia, it also has a profile for the same contraindications for GI, renal, and cardiac risk factors as other NSAIDs, as described previously. Toradol in all forms is listed as a pregnancy Category C drug, which means that the medication affects fertility and can harm an unborn baby. Taking the medication during labor can increase the risk of bleeding, and the medication also passes into breast milk. Based on the prostaglandin inhibition, Toradol is not recommended by the manufacturer for use in breastfeeding women, but the opinion of the American Academy of Pediatrics differs in this respect (www.drugs.com/pregnancy/ketoralac .com, last accessed 1/11/2013). Nursing mothers will need to consult their health care providers for guidance if they are considering the use of Toradol while breastfeeding.

NEW DEVELOPMENTS WITH NSAIDs Other new forms of NSAIDs have come to market recently. These types of NSAIDs are called targeted topical medications and are applied directly at the site of pain. Some of the medications are applied as liquids, while others have been made into patches. The newest formulation is a liquid made of diclofenac sodium, a topical solution called Pennsaid. The liquid can be applied directly to the knees for osteoarthritis patients. Diclofenac also comes as a 1% gel formulation (Voltaren gel) that is rapidly absorbed and is recommended for use on joints with osteoarthritis. The patient will need to apply the solution or gel to the affected joint 4 times per day.

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New Developments With NSAIDs

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A patch containing diclofenac epolamine 1% (Flector) has been used successfully for minor orthopedic injuries such as strains and sprains. The patch should be applied directly to the site of the injury. Despite the topical application, each medication has recommendations to use the smallest dose possible for the shortest period of time, and GI effects, though rare, cannot be excluded. In a Cochrane review comprising 47 studies comparing all types of targeted topical NSAID preparations, topical diclofenac, ibuprofen, ketoprofen, and piroxicam all had efficacy, but indomethacin and benzydamine had no better results than placebo (Massey, Derry, Moore, & McQuay, 2010). The number needed to treat to achieve 50% pain relief was 4.5 for 6 to 14 days. The Cochrane review concluded that the use of topical NSAIDs could provide a good level of pain relief without systemic adverse effects associated with NSAID use, with results limited to the treatment of acute musculoskeletal conditions (Massey et al., 2010). Case Study Sally J., 30 years of age, is a long-distance runner who recently has been experiencing some difficulty running her full daily schedule because of ankle and knee pain. She has tried Tylenol for pain relief but she cannot continue to run the distances she needs. She is considering trying NSAIDs for her pain, but is unsure if she should combine the two medications. She worries that taking all that medication can have a bad effect on her body. She is rating her pain at 7/10 when she finishes her run and notes some swelling and redness over her knees. What can you tell Sally about using a nonopioid medication for pain?

Questions to Consider 1. What type of pain is Sally having? Overuse injury–musculoskeletal, inflammatory, or a mixed presentation? 2. What are some of the risks for Sally using either Tylenol or NSAIDs long term for pain relief so she can continue to run? 3. Would you consider any of the new targeted medications such as a Flector patch, gel, or liquid? 4. If Sally continues to take these medications, what should you tell her about any side effects that she should be concerned about? 5. Would using a gastric prophylactic such as omeprazole protect Sally from developing any gastric side effects with NSAID use?

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60 3. Nonopioid Medications

REFERENCES Alazraki, M. (2009). The risk of over the counter meds: How many Tylenols have you taken today? Daily Finance. Retrieved July 1, 2009, from http://www.dailyfinance .com/2009/06/30 American Geriatrics Society. (2002). Persistent pain in older persons. Journal of the American Geriatrics Society, 50, S205–S224. American Geriatrics Society. (2009). The pharmacological management of persistent pain in older persons. Journal of the American Geriatrics Society, 57, 1331–1346. American Pain Society. (2008). Principles of analgesic use in the treatment of acute pain and cancer pain. Glenview, IL: Author. Barthelemy, O., Limberg, T., Collet, J., Beygai, F., Silvain, J., Belleman-Appaix, A., . . . Montalescot, G. (2011). Impact of non-steroidal anti-inflammatory drugs (NSAIDs) on cardiovascular outcomes in patients with stable atherothrombosis or multiple risk factors. International Journal of Cardiology, 163, 266–271. Bavry, A., Khlaiq, A., Gong, Y., Handberg, E., Coooper-DeHoff, R., & Pepine, C. (2011). Harmful effects of NSAIDs among patients with hypertension and coronary artery disease. American Journal of Medicine, 124, 614–620. Bennett, J. S., Daugherty, A., Herrington, D., Greenland, P., Roberts, H., & Taubert, K. A. (2005). The use of non-steroidal anti-inflammatory drugs (NSAIDs): A science advisory from the American Heart Association. Circulation, 111(13), 1713–1716. Brennan, F., Carr, D., & Cousins, M. (2007). Pain management: A fundamental human right. Anesthesia & Analgesia, 105(10), 205–221. Buvanendran, A., & Lipman, A. (2010). Nonsteroidal anti-inflammatory drugs and acetaminophen. In Bonica’s management of pain (4th ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Capone, M. L., Sciulli, M. G., Tacconelli, S., Grana, M., Riciotti, M., Randa, G. . . . Patrignani, P. (2005). Pharmacodynamic interaction of naproxen with low dose aspirin in healthy subjects. Journal of the American College of Cardiology, 45(8), 1295–1301. Catella-Lawson, F., Reilly, M., Kapoor, S., Cucchairia, A., DeMarco, S., Tournier, B. . . . Fitzgerald, G. (2001). Cyclooxygenase inhibitors and the anti-platelet effect of aspirin. New England Journal of Medicine, 345(25), 1809–1817. D’Arcy, Y. (2007). Pain management: Evidence based tools and techniques for nursing professionals. Marblehead, MA: HCPro. D’Arcy, Y. (2009a). Be in the know about pain management. Nurse Practitioner, 34(4), 43–47. D’Arcy, Y. (2009b). Opioid therapy: Focus on patient safety. American Nurse Today, 495, 18–22. D’Arcy, Y. (2009c). Treating low back pain with evidence-based options. Nurse Practitioner, 9, 17–18. Drugs.com. Toradol, ketorolac pregnancy and breastfeeding warnings. Retrieved January 11, 2013, from http://www.drugs.com/pregnancy/ketorolac.html Fine, P., & Portnoy, R. (2007). A clinical guide to opioid analgesia. New York, NY: Vendome Group Healthcare Division. He, A., & Hersch, E. (2012). A review of intranasal ketorolac tromethamine for the shortterm management of moderate to moderately severe pain that requires analgesia at the opioid level. Current Medical Research and Opinion, 28 (12), 1873–1880.

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References

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Karani, R., & Meirer, D. (2004). Systemic pharmacologic postoperative pain management in the geriatric orthopedic patient. Clinical Orthopaedics and Related Research, (425), 26–34. Institute for Clinical Systems Improvement. (2008). Assessment and management of chronic pain. Bloomington, MN: Author. Retrieved from www.guideline.gov Massey, T., Derry, S., Moore, R. A., & McQuay, H. (2010). Topical NSAIDs for acute pain in adults. Cochrane Database of Systematic Reviews, (6), CD007402. Moodie, J., Brown, C., Bisley, E., Weber, H., & Bynum, L. (2008). The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesthesia & Analgesia , 107(6), 2015–2031. Nursing 2010 Drug Handbook. (2009). Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins. Othman, M., Jones, L., & Neilson, J. P. (2012). Non-opioid drugs for pain management in labour (Review). The Cochrane Collaboration. The Cochrane Library, (7), CD009223. Perez-Gutthann, S., Garcia Rodriguez, L., & Raiford, D. S. (1997). Individual nonsteroidal anti-inflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology, 8, 18–24. Stanos, S., Fishbain, D., & Fishman, S., (2009). Pain management with opioid analgesics: Balancing risk and benefit. Physical Medicine & Rehabilitation, 88 (3, Suppl. 2), S69–S99. Sturkeboom, M. C., Burke, T. A., Tangelder, M. J., Deileman, J. P., Walton, S., & Goldstein, J. L. (2003). Adherence to proton pump inhibitors or H2-receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Alimentary Pharmacology and Therapeutics, 18(1-12), 1137–1147. Trescot, A., Helm, S., Hansen, H., Benyamin, R., Glaser, S., Adlaka, R., . . . Manchikanti, L. (2008). Opioids in the management of chronic non-cancer pain: An update of the American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician, 11(2S), S5–S62. Veterans Health Administration, Department of Defense. (2003). VADOD clinical practice guideline for the management of opioids therapy for chronic pain. Washington, DC: Author. Wallace, M., & Staats, P. (2005). Pain medicine and management. New York, NY: McGraw-Hill. World Health Organization. (1996). Cancer pain relief (2nd ed.). Geneva, Switzerland: Author.

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4 Opioid Medications

WOMEN AND OPIOIDS As discussed in Chapter 1, until 1993 women were excluded from early research and medication trials based on their child-bearing potential (Miaskowski, Gear, & Levine, 2000). In order to ensure safety for women in medication trials, the Food and Drug Administration (FDA) imposed guidelines on these trials that addressed: ■ The effect of the menstrual cycle and menopausal status on the pharmacokinetics of a drug ■ The effects of estrogen and oral contraceptives on the effectiveness of the drug (Miaskowski et al., 2000) By imposing these constraints it was hoped that more women could participate in drug trials and still have their reproductive safety preserved. There is a difference in the way women and men respond to opioids, and there are issues surrounding long-term opioid use in women. Over the past years, opioid prescribing for both women and men has increased dramatically, but women have issues that differ from men in that women can become pregnant and have estrogen fluctuation over the life span, and there are gender differences in prescription opioid use and abuse (Back, Lawson, Singleton, & Brady, 2011; Green, Serrano, Licari, Nudman, & Nutler, 2009). It is estimated that 4.7 million individuals 12 years of age and older used prescription opioids for nonmedical purposes within the previous month, with approximately 1.7 million individuals meeting criteria for dependence or abuse (Substance Abuse and Mental Health Services Administration [SAMHSA], 2009). Overall, the use of opioids has become a topic of great discussion, with prescribers experiencing pressure to decrease numbers of pills prescribed per month or to decrease opioid prescribing, which can seriously affect quality of life, especially for those patients with chronic pain. This information is salient for two reasons: women receive more prescriptions for opioid medications than men, and women tend to have higher rates of prescription opioid abuse (Back et al., 2011; Darnell & Stacy, 2012). Couple these facts with the reality that when women become pregnant and have pain, the prenatal effect on the fetus is a big concern. 63

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64 4. Opioid Medications Research has indicated that opioids are more likely to be prescribed to women and are prescribed at higher doses (Cicero et al., 2009). Several reasons seem to contribute to this phenomenon: ■ Women are at higher risk for developing a variety of chronic pain conditions ■ Women experience higher pain intensities than men ■ Inadvertent misprescribing of opioids for conditions common in women such as fibromylagia, osteoarthrtitis, or headaches where opioids are nonbeneficial (Darnell & Stacey, 2012). As discussed in Chapter 1, women and men have differing pain medication pathways that produce different responses, the major difference is that women have a better response to mixed agonist-antagonist medications. With opioids, men are seen as having a better response to morphine, but in fact, only the medication onset is faster. Even though the onset of action is slower in women, morphine can provide effective analgesia in women as well. However, women tend to: ■ Have more side effects such as nausea and vomiting from opioid use ■ Have an estrogenic effect that can increase certain types of pain such as inflammatory pain and modulate the pain response, while certain conditions such as fibromyalgia can alter and limit the binding capacity of opioids There are some distinct physiologic effects with continued opioid use. Morphine can affect temperature and circulating hormone levels by action in the hypothalamus. Continued use of morphine can lower body temperature and inhibit corticotrophin-releasing hormone (CRH) and gonadotrophin-releasing hormone (GnRH), which results in decreases in leutinizing hormone (LH), follicle-stimulating hormone (FSH), and adrenocorticotrophic hormone (ACTH). Conversely, prolactin and antidiuretic hormones are increased (Inturrisi & Lipman, 2010). These changes can affect fertility in women. When testosterone is affected in men due to chronic opioid therapy, a condition called opioid-induced androgen deficiency (OPIAD) results. When this condition occurs, pain worsens, depression is common, and efforts to treat the pain become very difficult. This phenomenon can also occur in women as the result of progesterone suppression (Inturrisi & Lipman, 2010). The research on differences in opioid response between men and women is very scant. It is an area that is just becoming a topic for research, with the focus of some studies on animal versus human response, so findings may not translate into human clinical practice. What is clear is that some medications seem to work better for women than men, and the full rationale behind these differences has yet to be uncovered.

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Opioid Medications

65

There are some seminal research studies that indicate there is a genetic component to the differences in opioid therapy, but the focus is on binding capacity rather than sex-related differences. In a review of postoperative pain, gender emerged as the biggest predictor for opioid consumption, with females consuming far fewer opioids, 23.5%, 37.5%, 43%, for postoperative days 1, 2, and 3, respectively. This is correlated with less pain than males overall, indicating that in the postoperative period women were experiencing less pain and requiring less opioid medication (Fillingim & Gear, 2004). Another study found that men had less binding site availability as a result of endogenous opioid activity, suggesting that women might have a greater response to exogenous opioids (Fillingim & Gear, 2004). As of the date of this publication, there is no definitive answer to the question of sex-related differences in opioid therapy. It is a rich area for research where more studies may yield important information that can be used clinically to improve pain relief for women.

OPIOID MEDICATIONS Today’s opioids can be delivered by a variety of routes, including oral, nasal, sublingual, intravenous, subcutaneous, intrathecal, and rectal. Additionally, there are many more opioid formulations to use for analgesia than just morphine, which for many years was considered to be the best medication for analgesia. This chapter will provide information on a wide variety of opioids that can be used to treat pain. The term opiate denotes a class of medications that are derived from the latex sap of the Papaver somniferum or opium poppy. The term opioid refers to synthetic or semisynthetic analogs to these natural substances. Opioids are any compounds that bind to an opiate receptor. Opium has a two-sided history: one as a potent analgesic and the other as a recreational drug; for example, it was smoked for its euphoric effect in the opium dens of China. Early herbalists recognized the painrelieving potential of opium and used it to treat many different types of pain in their patients. Morphine was first isolated in Germany in 1895, where the medication was thought to be useful as a cure for opium addiction (Fine & Portnoy, 2007). The development of the hypodermic syringe in the mid19th century gave medical practitioners another route for delivering opioid medications, which they injected directly into the site of the pain. By the 20th century, opioid use was not only seen as beneficial for treating pain, but it had also become problematic as opioid abuse increased.

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66 4. Opioid Medications The United States passed the first two acts for controlling the use of these substances: the Pure Food and Drug Act of 1906 and the Harrison Narcotics Act of 1914. These were the first two attempts at controlling the use and prescribing of opioid substances. As late as 1970, the Federal Controlled Substances Act provided standards for monitoring, manufacturing, prescribing, and dispensing of opioids and created the five-level division of controlled substances that we use today. Today the FDA has issued a requirement that all long-acting (LA) opioids need to have a Risk Evaluation and Mitigation Strategy (REMS) for prescribers who write prescriptions for LA opioids and rapid-acting fentanyl medications. Natural derivatives of opium include morphine, codeine, and heroin. Synthetic analogs such as fentanyl (Sublimaze) and meperidine (Demerol) were developed much later as attempts to perfect compounds for better pain relief. Several things that these compounds all have in common are: ■ They activate by binding sites in the body called mu receptors to produce analgesia. Mu receptors are found in many places in the body, including the brain and spinal column neurons ■ Their main action is analgesia ■ Side effects such as sedation, constipation, and nausea are common with all members of the drug class ■ They all have the potential for addiction

THE VARIOUS FORMS OF OPIOIDS Some opioids are used in the natural form, such as morphine and heroin. Other natural opium alkaloids include codeine, noscapine, papaverine, and thebaine (www.opiates.com). These alkaloids can be further reduced into more common analgesic compounds. The alkaloid thebaine is used to produce semisynthetic opioid morphine analogs such as oxycodone (Percocet, Percodan), hydromorphone (Dilaudid), and hydrocodone (Vicodin/Lortab). Other classes of morphine analogs include the 4-diphenylpiperidines, such as meperidine (Demerol), and diphenylpropylamines, such as methadone (Dolophine) (www.opiates.com). Each of these compounds was developed to either increase analgesic effect or reduce the potential for addiction. Although all of the opioid substances can be classed as analgesics, they vary as to potency. Each drug in the morphine group has a piperidine ring in the chemical configuration, or a greater part of the ring must be chemically present to be classed as a morphian (www.opiates.com). The main binding sites for opioids are receptor sites called mu receptors (Holden, 2005). These receptors are found in: ■ Brain cortex ■ Thalamus

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■ ■

Periaqueductal gray matter Spinal cord-substantia gelatinosa (Fine & Portnoy, 2007) Other secondary binding sites include the kappa and delta sites. Kappa sites are found in the brain-hypothalamus, periqueductal gray matter, claustrum and spinal cord-substantia gelatinosa (Fine & Portnoy, 2007). The delta receptors are located in the pontine nucleus, amygdala, olfactory bulbs, and the deep cortex of the brain (Fine & Portnoy, 2007). Recently, an opioid receptor-like site was discovered and called opioid receptor-like 1 (ORL1; Figure 4.1). The activity at this site is thought to be related to central modulation of pain but does not appear to have an effect on respiratory depression (Fine & Portnoy, 2007) When an opioid is introduced into a patient’s body, it looks for the binding site that conforms to a specific protein pattern that will allow the opioid to bind to the receptor site and create an agonist action, analgesia. At one time the binding action for opioids was felt to be a simple lock-andkey effect; that is, inject the medication, the medication goes to the receptor binding site, binds, and thus creates analgesia. Today we know that the process is much more specific and is more sophisticated than previously understood. Once the opioid molecule approaches the cell, it looks for a way to bind. On the exterior of each cell are ligands, or cellular channel mechanisms connecting the exterior of the cell with the interior, which convey the opioid molecule into the cell. The ligands are affiliated with the exterior

nerve terminals

morphine opiate receptors

cell membrane

Figure 4.1 ■ Opioid receptor-like 1 site.

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68 4. Opioid Medications receptor sites and can contain a variety of G-proteins. These G-proteins couple with the opioid molecule and mediate the action of the receptor (Fine & Portnoy, 2007). “One opioid receptor can regulate several G proteins, and multiple receptors can activate a single G protein” (Fine & Portnoy, 2007). As efforts progress to better identify the process, greater than 40 variations in binding site composition have been identified (Pasternak, 2005). These differences explain some of the variation in patient response to opioid medications. The body also has natural pain-facilitating and pain-inhibiting substances. These include: ■ Facilitating: Substance P, bradykinin, and glutamate ■ Inhibiting: Serotonin (central), opioids—natural or synthetic, norepinephrine, and GABA (D’Arcy, 2007) When these substances are activated or blocked, pain relief can be enhanced or decreased. These more complex mechanisms are difficult to clarify and trying to link them to a specific mechanism of analgesia and opioid effect can be misguided. In women, the hormonal effect of estrogen has a powerful painregulating effect. Estrogen receptors are widely located throughout the body and located near nociceptive center creating strong pro- and antinociception (Craft, 2007). Estrogen has been highly associated with producing inflammatory pain (Cairns & Gazerani, 2009; Craft, 2007). In younger women inflammatory pain may be more common, as estrogen levels are higher. However, as women go through menopause, both the estrogen and anti-inflammatory effects lessen. This explains in some part the incidence of pain in women who have osteoarthritis as well as other musculoskeletal and stress-related conditions such as migraines. Research today is focusing on glial cell activity and identifying substances that are active in opioid mechanisms.

FORMULATIONS OF OPIOID MEDICATIONS Opioid medications are very versatile in that they can be given as standalone medications, such as oxycodone, or combined with another type of nonopioid medication such as a nonsteroidal anti-inflammatory drug (NSAID); e.g., oxycodone combined with ibuprofen (Combunox), or oxycodone combined with acetaminophen (Percocet). Opioids can be formulated as elixirs (such as morphine [Roxanol]) or as suppositories (such as hydromorphone [Dilaudid]). Since the morphine elixir form can be very bitter, adding a flavoring available at most pharmacies can help the patient tolerate the taste of the medication.

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Oral short-acting preparations are usually listed as having a duration of 4 to 6 hours, but each patient has an individual response and ability to metabolize medications. For example, the duration of action of shortacting morphine may be 3 to 7 hours (Quill et al., 2010). Most of the combination medications are categorized as short acting, and the combination of other dose-limited medications such as acetaminophen limits the amount of medication that can be taken in a 24-hour period. Those that are combined with acetaminophen follow the recommended maximum dose for daily acetaminophen intake of 4,000 mg/day (American Pain Society [APS], 2008). Many opioids are created in LA, sustained-release (SR), and extendedrelease (ER) formulations that can be dosed every 12 to 24 hours (e.g., oxycodone SR [OxyContin], oxymorphone ER [Opana ER], or morphine [Kadian, Avinza]). These ER medications are particularly helpful for patients when pain is present throughout the day. They are not designed to be used in patients who are opioid naïve, but for those that have been taking short-acting medications regularly to control their pain. Some LA opioid medications such as the fentanyl (Duragesic) patch have specific short-acting medication requirements before they can be started. For example, before initiating fentanyl 25 mcg/hour patch, the patient must have been using a total daily dose of at least 60 mg morphine, 30 mg oxycodone, or 8 mg hydromorphone by mouth per day for 2 weeks prior to patch application (Janssen prescribing information available at www.janssen.com). Every patient who uses an ER opioid medication for pain should have a short-acting medication available to take for worsening pain. Referred to as breakthrough pain, this is increased intensity of pain that occurs spontaneously, with increased activity, or from end-of-dose failure of the LA agent (APS, 2008). Clinical Pearl

Opioid naïve: Pa ents who are not chronically taking opioid medica ons on a daily basis Opioid tolerant: Pa ents who take opioid medica on regularly for 1 week or longer, in these doses or more (FDA, 2011; NCCN, 2011; Stokowski, 2010): • 60 mg oral morphine/day • 25 mg transdermal (TD) fentanyl/hour • 30 mg oral oxycodone/day • 8 mg oral hydromorphone/day • 25 mg oral oxymorphone/day • An equianalgesic dose of any other opioid

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70 4. Opioid Medications No matter what type or form of opioid medication is being considered for use, the health care prescriber should be aware of the risks and benefits of each medication and weigh the options carefully. A full history and physical should be performed. A detailed risk assessment for possible opioid misuse should also be done. Information on opioid prescribing safety will be provided in Chapter 12 of this book.

SHORTACTING COMBINATION MEDICATIONS Short-acting pain medications last for several hours at the recommended doses. For most patients, a short-acting medication is appropriate when pain is less severe and does not last throughout the day or night. Some patients do not have high levels of pain, and short-acting opioids may sufficiently control the pain. Patients with more severe pain intensities and consistent daily pain require a more complex medication regimen to control their pain effectively. Most short-acting medications are oral, as either pills or elixirs. Some patients may have difficulty swallowing pills but can tolerate an elixir, either swallowed or by the sublingual route. Intramuscular (IM) administration of opioids is no longer recommended because the IM route causes irregular absorption and tissue sclerosis. Therefore, most national guidelines have removed the IM route from their recommendations (APS, 2008; ASPMN, 2009). Most short-acting opioid medications are designed for moderate to severe pain intensities. Onset of action is usually 10 to 60 minutes with a short duration of action, 2 to 6 hours (Katz, McCarberg, & Reisner, 2007). Overall advantages to short-acting medications include a synergistic effect if combined with acetaminophen or ibuprofen to improve pain relief and provide a better outcome. However, if patients have liver impairment from their disease, the use of acetaminophen products is discouraged.

Medications Morphine: Immediate-release morphine sulfate (MSIR), Roxanol elixir Morphine is the gold standard for pain relief. It is the standard for equianalgesic conversions and has a long history of use in many different forms for pain control. It is available is many different forms: pill, elixir, intravenous, and suppository. It is indicated for severe pain. The biggest drawback to morphine is the side effect profi le: constipation, nausea/ vomiting, delirium, and hallucinations are some of the most commonly reported adverse effects.

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Oxycodone-containing medications: Oxycodone, Percocet, Roxicet, Percodan, Oxifast Medications with oxycodone are designed for treating moderate pain. They are commonly used for patients with higher pain intensities and for patients with chronic pain. Percocet is a combination medication with 5 or 10 mg of oxycodone and 325 mg of acetaminophen. (Percodan is oxycodone combined with aspirin. If the patient requires a higher dose of medication for pain control, combining an oxycodone 5-mg tablet with a combined form such as Roxicet (oxycodone 5 mg/acetaminophen 325 mg), or using a tablet with the dose of 10 mg of oxycodone with 325  mg of acetaminophen, will provide additional pain relief but still maintain the acetaminophen dose at 325 mg. To help patients tolerate the medication without nausea, giving the medication with milk or after meals is recommended (Nursing 2014, 2014). Oxymorphone-containing medications: Opana Opana is medication designed to treat moderate to severe pain. The medication has a more extended half-life than other medications of the same class, resulting in a decreased need for breakthrough medications (Adams et al., 2004; Adams & Abdieh, 2005). The medication should be taken 1 hour before or 2 hours after a meal (Nursing 2014, 2014). Hydromorphone: Dilaudid Dilaudid is an extremely potent analgesic and is designed to treat severe pain. In the oral form it comes in 2-mg, 4-mg, and 8-mg tablets. It also comes in a suppository form. In the IV form, 0.2 mg of Dilaudid is equal to 1 mg of IV morphine. Because of the strength of this medication, it is possible to give small amounts, get good pain relief, and potentially have fewer side effects. It is not available in combination form with acetaminophen. Therefore, doses can be titrated as needed to achieve adequate pain relief. Fentanyl transmucosal: Actiq, Fentora, Onsolis, Lasanda There is no oral formulation for fentanyl. The route of administration is either transdermal, buccal, nasal, or intravenous. When used buccally for breakthrough pain in opioid-tolerant patients, the transmucosal medications can be rubbed across the buccal membrane and absorbed directly into circulation. The fast absorption makes this medication a risk for oversedation, so the indication is only for breakthrough pain in opioid-tolerant cancer patients who take opioid medications on a daily basis. If the entire dose of an Actiq oralet is not used it should be placed in a childproof container and disposed of. This medication is not meant to be used for acute or postoperative pain (Nursing 2014, 2014). It also is not

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72 4. Opioid Medications meant to be used in opioid-naïve patients since serious oversedation can occur (Fine & Portnoy, 2007). Hydrocodone-containing medications: Vicodin, Lortab, Norco, Lortab elixir Hydrocodone-containing medications are designed to be used for moderate pain. They usually contain 5 to 10 mg of hydrocodone with 325 mg or 500 mg of acetaminophen. Many patients tolerate the medication very well for intermittent or breakthrough pain. It has an elixir form that is very effective and can be used in patients who have difficulty swallowing pills or patients with enteral feeding tubes. Norco has a higher dose of hydrocodone per tablet.

Other Drugs Tramadol (Ultram, Ultracet), Tapentadol Tramadol and tapentadol are a unique class of drug with weak (tramadol) or moderate (tapentadol) mu agonist (opioid-like) and SSRI-selective serotonin reuptake inhibitors properties (APS, 2008). It is designed for use with moderate pain. Doses should be reduced for patients with increased creatinine levels, cirrhosis, and in older patients. These drugs may increase the risk for seizures and serotonin syndrome (Nursing 2014, 2014). Patients should be instructed to taper off the medication gradually when discontinuing. It should not be stopped suddenly (Nursing 2014, 2014). Because of the chemical structure with similarities to SSRI, tramadol or tapendadol use is not recommended in patients receiving active chemotherapy.

EXTENDEDRELEASE MEDICATIONS PAIN RELIEF FOR CONSISTENT PAIN AROUNDTHECLOCK PAIN RELIEF ER medication can give a consistent blood level of medication that can provide a steady comfort level. This may increase functionality and improve quality of life, enhance sleep, and let the patient participate in meaningful daily activities. ER medications have a slower onset of action (30 to 90 minutes), with a relatively long duration of action (up to 72 hours; Katz et al., 2007). When a patient has pain that lasts throughout the day and the patient has reached the maximum dose limitations of opioid short-acting medications, the prescriber should consider switching the patient to an ER or LA medication. Some of the short-acting medications have an ER formulation, such as Opana ER, Ultram ER, Oxycontin, Kadian, Avinza, and MS Contin. Most are pure mu agonist medications such as morphine with an ER action that allows the medication to dissolve slowly in the GI tract. Some ER medications are encapsulated into beads that allow gastric

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secretions to enter the bead and force the medication out. Other ER formulations have a coating around an ER plasticized compound that keeps the medication from dissolving too quickly. When ER medication is being initiated, the patient should be instructed on the important aspects of the medications. Important information includes: ■ ER medications of all types should never be broken, chewed, or degraded in any way to enhance the absorption of the medications. To do so may result in all the medication being given at one time, which creates a high risk for potentially fatal oversedation. Most ER medications are being formulated in tamper-resistant formulations to decrease the potential for misuse. ■ Most ER medications should not be taken with alcohol. To do so modifies the ER mechanism and allows for a faster absorption, which can cause potentially fatal oversedation. ■ ER medications are not meant to be injected. ■ ER medication should not be crushed and inserted into enteral feeding tubes. This would release the total dose of the tablet at one time ■ Enteral administration of LA morphine (Kadian ER) is an option when a 16-F or larger gastrostomy tube is present. Kadian ER capsules are filled with pellets. The capsules are opened and mixed into 10 mL of water. This solution is poured into the gastrostomy tube through a funnel, followed by a 10 mL flush of water (Kadian Package Insert, 2010). Both Kadian ER and Avinza ER pellets may also be sprinkled onto applesauce if the patient can swallow some food. These brandname formulations are more expensive. ■ ER medications are meant to be used on a scheduled (not an “as-needed”) basis (APS, 2008). ■ If the patient experiences end-of-dose failure several hours before the next dose of medication is due, the interval should be shortened (e.g., every 8 hours instead of every 12 hours) or the dose should be increased (APS, 2008). When switching a patient from short-acting medications, the rule of thumb is: ■ If the medication is the same (oxycodone short-acting and oxycodone SR), the equivalent doses of the medication can be prescribed. For example, if the patient is taking oxycodone 5 mg tablet, 4 to 6 tablets per day, the patient can be safely started on oxycodone SR (OxyContin) 10 mg twice a day. ■ If the medication is a different drug, such as oxycodone short acting to morphine CR (MS Contin), the daily dose should be calculated using the equianalgesic conversion table (see Appendix B) and reduced, usually by 30%. To ensure adequate pain relief is maintained, additional doses of breakthrough medication should be prescribed—about 5% to 15% of the total daily dose, to be taken every 2 hours as needed (APS, 2008).

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74 4. Opioid Medications Because these ER medications are potent, the use of tamper-resistant formulas is highly recommended. Some ER medication now will dissolve into a gum-like substance when there is an attempt to crush the medication for abuse. This does not allow the opioid component to be released. Other formulas contain a mu antagonist medication such as naltrexone that will activate and neutralize the opioid effect of the medication when tampering is attempted. Methadone: Dolophine Methadone is considered to be a LA medication because it has an extended half-life of 15 to 60 hours (APS, 2008). However, pain relief for the oral form is less extended at 6 to 8 hours (Nursing 2014, 2014). Therein lies the danger. If the half-life is long and the pain relief is shorter, dosing must be done carefully to avoid oversedating the patient, which may become apparent only a day or two after the doses are given. Dose escalation should be done no more often than every 5 to 7 days (APS, 2008). Methadone can be prescribed for pain relief by physicians, nurse practitioners (NPs), and physician assistants (PAs) in primary care and oncology. It is also used for opioid substitution therapy (e.g., methadone maintenance) to control addiction in heroin and other opioid addicts. A special license is required to prescribe methadone for addiction management. The addiction program has no connection to prescribing methadone for pain management. However, since there is such a high risk of adverse events with this medication, the current recommendation by the APS is that only pain management practitioners or those skilled and knowledgeable about the use of methadone prescribe the drug (APS, 2009; D’Arcy, 2009). An additional risk factor for methadone is the potential for QTc interval prolongation. This puts the patient at risk of the potential deadly ventricular arrhythmia of torsades de pointes (APS, 2008). Health care providers are advised to obtain a baseline ECG with periodic follow-up monitoring for patients who are receiving methadone for long term pain management. At a QTc prolongation of >450, consideration should be given to reducing the dose of methadone or switching to another drug (APS, 2008). Combinations of drugs that increase the risk of QTc prolongation require more careful monitoring. Fentanyl TD patch: Duragesic Fentanyl patches can provide a high level of pain relief and are used for a variety of chronic pain conditions. They are the only TD opioid treatments available for use. The fentanyl TD (Duragesic) patch is a delivery system that contains a specified dose of fentanyl in a gel formulation. It is designed for use among opioid-tolerant patients and should never be used for acute pain or with opioid-naïve patients.

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The fentanyl TD patch should be applied to clean, intact, nonhairy skin. It delivers the specified amount of medication for 72 hours, for example, 25 mcg per hour (D’Arcy, 2007). The systemic medication effect begins after the medication depot develops in the subcutaneous fat, which can occur 12 to 18 hours after application ( D’Arcy, 2007, 2009). It can also take up to 48 hours for steady-state blood levels to develop, so when the fentanyl TD patch is being started, the patient may need additional short-acting pain medication to control breakthrough pain (D’Arcy, 2009). There are some safety concerns with fentanyl TD (Duragesic) patch use. There have been more than 100 patients who have died related to fentanyl patch use and misuse. When a TD patch is prescribed for pain relief, patient education should include: ■ Do not cut the patch. Doing so will result in a dose-dumping effect where all the medication is released at one time, resulting in an overdose. ■ Do not apply heat over the patch. Use of heating pads will result in accelerated medication delivery that could result in an overdose. ■ Dispose of the patch properly. Since there is medication left in the patch, safe disposal is necessary to avoid diversion. Seal in a baggy with kitty litter or used coffee grounds. Bag the garbage and put it in an outside garbage receptacle immediately. There is about 16% of the dose remaining in the patch after use, and an animal or small child could remove the patch and chew or place it on themselves, resulting in overdose (D’Arcy, 2009). ■ Fentanyl patches should only be started on an opioid-tolerant patient. In order to place a 25 mcg fentanyl patch, the patient should be taking one of the following: 30 mg of oxycodone per day for 2 weeks, 8 mg of hydromorphone per day for 2 weeks, or 60 mg of oral morphine per day for 2 weeks (Janssen prescribing information available at www.Janssen.com). Rapid-acting fentanyl products for breakthrough cancer pain: Onsolis, Lasanda, Oralets ■

Fentanyl (Actiq) oralets are a form of rapid-onset fentanyl. These are rubbed against the buccal membrane, releasing the prescribed dose of medication. The oralets come in 200, 400, and 800 mcg. The oralet may be used up to four times per day. Patients must be taught to “paint” the buccal surface with the oralet, and keep it in constant motion. They should not “suck” on the oralet as a candy sucker. It takes about 15 to 20 minutes to use the medication. Unused medicine should be dissolved under very hot water. Partially used oralets must be destroyed and not left lying around, as a child or pet could die from ingestion of leftover medicine.

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■

■

Fentanyl (Onsolis) buccal film is a small strip that is applied to the buccal membrane and slowly releases the prescribed dose of medication. The starting dose of Onsolis is 200 mcg, which is equivalent to 200 mcg Actiq. Fentanyl (Lasanda) nasal spray uses a pectin base that has an extremely rapid onset of action (15 minutes) and is well tolerated by patients. The starting dose of Lasanda is 100 mcg. Fentanyl (Fentora) buccal tablet is a dissolvable tablet of fentanyl that rapidly dissolves when placed against the buccal membrane. The starting dose of Fentora is 100 mcg, which is equivalent to 200 mcg Actiq.

Medications That Are No Longer Recommended There are two pain medications that are no longer recommended for use due to toxic metabolites, poor pain relief, or high profile for side effects. Codeine-containing medications: Codeine, Tylenol #3 (Codeine 30 mg combined with acetaminophen 325 mg) Codeine use is discouraged. It is effective only for mild pain, and causes significant nausea and constipation. In addition, many authors believe that, unlike other opioids, codeine has an analgesic ceiling (meaning that higher doses of the drug do not provide more analgesia). In addition, the number needed to treat is high, at 11. This means you would see the first effective analgesic effect in the 12th patient who was given the medication for pain relief. About 10% of the people lack the enzyme needed to convert codeine to the active metabolite of morphine (APS, 2008). Meperidine Meperidine (Demerol) has also fallen out of favor. It is no longer considered a first-line pain medication (APS, 2008; D’Arcy, 2007). Meperidine has a toxic metabolite, normeperidine, that accumulates with repetitive dosing (APS, 2008). This metabolite can cause tremors and seizures. Other drawbacks include the need to use high doses to achieve an analgesic effect, often accompanied by sedation and nausea (D’Arcy, 2007). If meperidine is going to be used, the following recommendations should be made: ■ Meperidine should never be used with children and infants ■ It should never be used in patients with renal impairment, for example, sickle cell, multiple myeloma, or older patients ■ A potentially fatal hyperpyrexic syndrome with delirium can occur if meperidine is used in patients who are taking monoamine oxidase inhibitors ■ If used, it should never be for more than 1 to 2 days at doses not to exceed 600 mg/24 hours (APS, 2008)

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Mixed Agonist/Antagonist Medications This class of medication can provide good pain relief for women, though not for men. This is the result of a pain pathway that is active in women but is reduced or inactive in men. These medications have both an agonist and antagonist action at the various binding sites throughout the body. For this reason these medications are termed mixed agonist/antagonist medications. These medications include: ■ Buprenophrine (Buprenex injection or sublingual Temgesic, Butrans TD patch) ■ Nalbuphine (Nubain) ■ Pentazocine (Talwin) These medications act at the kappa receptor sites, so the potential for respiratory depression is felt to be less. Since these medications have both an agonist and antagonist action, they have the potential for reversing the opioid effect of pure opioid agonists such as morphine. If a patient is taking morphine, giving a mixed agonist/antagonist medication will reverse the effect of the morphine and pain relief is lessened. This group of medications also has a high profile for adverse side effects such as confusion and hallucinations, and has dose ceilings that limit dose escalations (APS, 2008). Use of pentazocine is no longer recommended due to a high incidence of adverse effects. Buprenorphine (Butrans), a TD buprenorphine patch, has been promoted for use in chronic pain, that is, osteoarthritis and low back pain. Its action is partial agonism at the mu receptor sites with antagonist activity at the kappa receptor (Plosker, 2011; Plosker & Lyseng-Williamson, 2012). The risk of respiratory depression with buprenorphine is low unless used concomitantly with other central nervous system depressants (Plosker, 2011). The Butrans patch comes in doses of 5, 10, and 20 mcg and is administered once every 7 days (Plosker, 2011; Plosker & Lyseng-Williamson, 2012) with a recommended starting dose of 5 mcg per hour. The recommended application sites are the upper outer arm, upper chest, upper back, and side of the chest, with rotation of sites required (Plosker, 2011). In an observational study with 4,263 patients using Butrans (67% being women), initial pain scores of 6.9 on the NPI scale were reduced to 2.9 over an 8-week period of time (Plosker, 2011). In a study with 246 osteoarthritis patients comparing sublingual buprenorphine tablets and Butrans, both medications reduced pain and improved quality of life. The Butrans patch had analgesic effect for the full 7 days and it is expected that medication compliance is improved by use of a 7-day medication rather than repeated sublingual dosing, especially in older patients (James, O’Brien, & McDonald, 2010).

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78 4. Opioid Medications

Selecting an Opioid Selecting an opioid for an individual patient can involve a trial and error process. Each individual has a genetic preference for one or more types of opioids. The challenge is determining which opioid works best for the patient. Many patients have tried opioids before for surgery or acute pain from injuries. They may know which one works best and which ones don’t work at all. If the patient can provide you with information on the efficacy of pain medications, it should not be considered drug seeking or potential addiction. If the patient has used a medication successfully, starting with one that was effective will in many cases provide the best outcome. Conversely, if the patient tells you that she has tried a medication but it didn’t work, get more information about when, for what indication, and what doses were tried. In many cases patients with pain have been underdosed with medications and they then feel the medications are “not working” or are ineffective. If the correct dose of medication had been provided, the medication could have provided good pain relief. It is always wise to revisit the use of a medication that has been underdosed, this time using appropriate doses for treating pain, unless there are side effects that would contraindicate the use of the drug.

RISK EVALUATION AND MITIGATION STRATEGIES REMS Although REMS is a new concept for opioids, it has been used for years for medications such as thalidomide for multiple myeloma treatment to give prescribers the knowledge to prescribe medications with special risk factors. For opioids, LA formulations and newer medications such as some of the rapid-acting fentanyls have been identified as having higher risks. As a result, the FDA has asked the manufacturers to develop REMS programs for their medications. Most REMS programs consist of an educational component that the prescriber must complete correctly to be allowed to prescribe the medication. This has a two-sided effect. One side is the extra education that these prescribers get about the medication they are prescribing. The other side is the need to have a REMS certificate to prescribe these medications, making it easier for the prescriber to use other non-REMS–cited medications such as short-acting opioids. In the best scenario, the prescriber will deem the extra education helpful in ensuring that these potent medications are prescribed correctly. In the worst-case scenario, REMS may limit the prescribing practice of health care providers. Overall, the use of REMS should make prescribing practice safer for both the health care provider and the patient.

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Opioids in the Older Patient

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OPIOIDS IN THE OLDER PATIENT Older patients have a large number of conditions such as osteoarthritis and other painful comorbidities. Choosing a medication to treat pain in these patients is more of a challenge. The myth that older patients do not tolerate pain medications is just that—a myth. Older patients can use opioid medication to manage pain with good effect if careful dosing and titration take place. In 2009, the American Geriatrics Society (AGS) updated their pain management guidelines for persistent noncancer pain in older patients. These guidelines indicate that opioids are an option for the older patient when moderate to severe pain is present. For older patients, pain is experienced in the same way as younger patients but aging can change the way the nervous system perceives the pain and transmission may be altered (Huff man & Kunik, 2000; McLennon, 2005). Aging can also change the way the older patient’s body processes pain medications, and can increase the potential for adverse effects. Some of the reasons an older patient may experience adverse effects from opioids include: ■ Muscle-to-fat ratios change as a patient ages, causing the body fat composition to be altered ■ Poor nutrition can decrease protein stores, which in turn can decrease the binding ability of some medications ■ Because of the changes in the protein-binding mechanisms, drugs may need to compete for binding sites, making one or more of patient’s medications ineffective ■ Aging affects the physiologic functions of metabolism, absorption, and medication clearance, including a slowed gastrointestinal motility, decreased cardiac output, and glomerular filtration rate ■ Baseline changes in sensory and cognitive perception can serve as an increased risk for side effects among some patients, such as sedation and confusion related to opioid use ■ Drug excretion and elimination are reduced by 10% for each decade after 40 because of decreased renal function (Bruckenthal & D’Arcy, 2007; D’Arcy, 2009; Horgas et al., 2003). The old adage of “start low and go slow” still applies to starting opioid therapy in older adults. Older patients are not all the same, and bodies age in different ways. Using conservative doses and monitoring the patient carefully for side effects can help ensure that opioids are being used to provide the highest possible pain relief but also that the medication is being used safely.

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80 4. Opioid Medications

TIPS FOR STARTING ANALGESIC MEDICATION IN THE OLDER PATIENT Since the older patient has pain needs yet requires more monitoring of dosing and adverse effects, starting new medications can be somewhat complicated. Recommendations for pain medications for the older adult include: ■ Reduce the maximum daily acetaminophen dose from 4,000 mg to 1,000 to 2,000 mg per day. ■ Decrease acetaminophen doses even further or do not use at all if the patient has a history of alcohol use/abuse, or liver or renal impairment (AGS, 2002, 2009). ■ Reduce beginning opioid doses by 25% to 50% to decrease the potential for oversedation. ■ Scheduling medication may provide better pain relief and reduce the likelihood of needing increased doses for uncontrolled pain. ■ Monitor older adults being started on opioid therapy daily, if not more frequently, since organ impairment may decrease the elimination of the medication. ■ For older patients, avoid the use of the following medications because of unwanted side effects and/or toxic metabolites: meperidine, pentazocine, indomethacin, and amitriptyline (D’Arcy, 2009; McLennon, 2005).

TREATING OPIOID SIDE EFFECTS All opioids have the potential for side effects. There is no magic opioid or pain medication that does not have the potential for constipation, sedation, or pruritis. When a patient indicates an allergy to a medication, it is important for the prescriber to determine if what the patient perceives as an allergy is just an unwanted side effect. Opioids can be used in the presence of side effects, but treatment options to control the unwanted effects or dose reductions to minimize the side effects should be used. The one important concept to remember here is that adding a medication that is sedating, such as phenergan, can potentiate sedation from an opioid. Before deciding that an opioid is too sedating, look at all sedating medications that are being used concomitantly and try to minimize the use of additional sedating agents.

Constipation Constipation is a common side effect of opioid use. It is the one effect to which the patient will not become tolerant. Every patient who is prescribed an opioid should have a laxative of some type. Stool softeners are also used

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to ease bowel movements. Stimulant laxatives are used to counteract the constipation. Combination stool softener/laxatives are available over the counter in most drug stores. Recommended types of laxatives include: ■ Senna or senna with stool softener (increases bowel motility) ■ Bisacodyl (increases bowel motility) ■ Lactulose (osmotic laxative) ■ Sorbitol (easily found in Sorbee candies; osmotic laxative) ■ Methylnaltrexone (Relistor; approved for opioid-induced constipation for patients with advanced illness or a palliative care-subcutaneous injectable; APS, 2008)

Sedation Sedation occurs most commonly at the beginning of opioid therapy (D’Arcy, 2007). Patients may become sedated when opioids are first started, but they become tolerant to the effect within a period of 2 weeks or less. If sedation persists or reaches high levels, dose adjustments should be made so that serious oversedation does not occur. Patients should be monitored for sedating effects of the opioid and additive sedating effects from medications that are sedating, such as antiemetics, sedatives, antihistamines, muscle relaxants, sleeping medications, benzodiazepines, and so forth. To counteract sedation, stimulants such as caffeine, dextroamphetamine, methylphenidate, or modafinil can be used. The medications listed above are most commonly used for patients with chronic cancer pain. Most patients adjust to the sedating effects of opioids within a few weeks at the longest, but the use of caffeine can be recommended for almost any patient.

Pruritis (Itching) Some patients who are started on opioids or are taking high doses of opioids may develop pruritis (itching). It is the result of a histamine release and it is not an indication of a true allergy. The most common way to counteract the itching is to use an antihistamine such as diphenhydramine (Benadryl). If the itching persists, changing to another opioid may reduce or eliminate this effect.

Delirium/Confusion Many patients, especially older patients, become confused when they are moved from their usual living situation and put into a new situation, or have surgery and start opioids. For patients with opioid dependent chronic pain the incidence of confusion or delirium related to opioid use should

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82 4. Opioid Medications be much less. Delirium can be caused by opioids and is a temporary state. If the patient becomes delirious, changing the opioid, reducing the dose, or stopping the opioid may provide the needed intervention. Some opioids such as morphine have a higher profile for confusion. Changing to another medication such as low-dose Dilaudid may provide adequate pain relief and lessen the potential for confusion.

Nausea/Vomiting Opioids have a high profile for nausea and vomiting. For most opioids, taking the medication with a small amount of food or milk will help to reduce the effect. If the nausea and vomiting don’t resolve, using an antiemetic regularly until the effect abates is the best option. Since all antiemetics are sedating, there will be an additive sedating effect when the medications are combined. Recommended antiemetics include: ■ Ondansetron ■ Phenergan (caution with IV administration; can cause tissue necrosis) ■ Reglan ■ For motion-induced nausea, meclizine or cyclizine ■ For severe cases, scopolamine patches (APS, 2008) Case Study Cindy is a 46-year-old mailperson. She delivers mail and packages on a daily basis to customers in a rural setting. Her job requires a lot of up-and-down movement and some heavy lifting if packages are large. She drives a jeep long distances over uneven roads. Cindy has low back pain from a motor vehicle accident. She had unsuccessful surgery to repair the damage. Recently she has had a shooting pain that goes down her right leg. This limits her ability to drive and to put pressure on the vehicle pedals. She wonders if there is any medication she can take that will help with the pain. She sleeps poorly as the pain has gotten worse and she rates her daily pain at 5/10 and nighttime pain at 7/10. The radiating pain is short lived but she rates that as 10/10 when it occurs. When you ask about her pain medications, Cindy tells you she takes 4 Percocet a day, but they seem to be helping less and less. She wants a pill to help her sleep. This constant pain is making her depressed and she wonders just how long she can continue to deliver mail.

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References

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Questions to Consider 1. Should you begin an ER pain medication—oxycodone ER or morphine ER? Which do you think would be the best one to try? 2. Should you add a neuropathic pain medication? Would you recommend starting with an anticonvulsant (such as gabapentin), or an antidepressant (such as duloxetine or amitriptyline)? 3. Should you continue the oxycodone/acetaminophen for breakthrough pain? Would you consider using a rapid-acting fentanyl product for breakthrough pain? 4. Should you continue the muscle relaxant for muscle spasms? Do you think it makes any difference for the pain related to muscle spasms? 5. What do you think about Cindy driving daily while on opioids? Should she tell her employer that she is taking Percocet daily for pain control? 6. What might be a better option to improve Cindy’s sleep without using a sleeping pill and might also help with her depression?

HELPFUL WEBSITES www.opiates.net/ The Plant of Joy: A Brief History of Opium. opioids.com/opium/history/index Opium: Opium History up to 1858 AD by Alfred McCoy.

REFERENCES Adams, M., & Abdieh, H. (2004). Pharmokinetics and dose proportionality of oxymorphone extended release and its metabolites: Results of a randomized crossover study. Pharmacotherapy, 24(4), 468–476. Adams, M., Pieniaszek, H., Gammaitoni, A., & Abdieh, H. (2005). Oxymorphone extended release does not affect CYP2C9 or CYP34A metabolic pathways. Journal of Clinical Pharmacology, 45, 337–345. American Geriatrics Society. (2002). Persistent pain in the older patient. Journal of the American Geriatrics Society, 50, 205–224. American Geriatrics Society. (2009). The pharmacological management of persistent pain in older persons. Journal of the American Geriatrics Society, 57, 1331–1346. American Pain Society. (2005). Cancer pain in adults and children. Glenview, IL: Author. American Pain Society. (2008). Principles of analgesic use in the treatment of acute pain and cancer pain. Glenview, IL: Author. American Society of Pain Management Nursing. (2009). Core curriculum for pain management nursing. Dubuque, IA: Kendall Hunt Publishing.

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84 4. Opioid Medications Back, S., Lawson, K., Singleton, L., & Brady, K. (2011). Characteristics and correlates of men and women with prescription opioid dependence. Addictive Behaviors, 36 , 829–834. Brukenthal, P., & D’Arcy, Y. (2007). Assessment and management of pain in older adults: A review of the basics. Topics in Advanced Practice Journal, 7(1). Retrieved July 2009 from http://www.medscape.com/viewarticle Cairns, B., & Gazerani, P. (2009). Sex-related differences in pain. Matauritas, 63, 292–296. Cicero, T., Wong, G., Tian, Y., Lynskey, M., Todorov, A., & Isenberg, K. (2009). Co-morbidities and utilization of services by pain patients receiving opioids medications: Data from an insurance claims database. Pain, 144(1–2), 20–27. Craft, R. (2007). Modulation of pain by estrogens. Pain, 132, S3–S12. D’Arcy, Y. (2007). Pain management: Evidence based tools and techniques for nursing professionals. Marblehead, MA: HCPro. D’Arcy, Y. (2009). Avoid the dangers of opioid therapy. American Nurse Today, 4(5), 16–22. D’Arcy, Y. (2009). Pain in the older adult. Indianapolis, IN: Sigma Theta Tau. Darnell, B., & Staacey, B. (2012). Sex differences in long-term opioid use. Archives of Internal Medicine, 172 (5), 431–432. FDA. (2011, October 2). FDA for health professionals. Retrieved from U.S. Food and Drug Administration: http://www.fda.gov Fillingim, R., & Gear, R. (2004). Sex differences in opioid analgesia: Clinical and experimental findings. European Journal of Pain, 8, 43–425. Fine, P., & Portnoy, R. (2007). A clinical guide to opioid analgesia. New York: Vendome Group, LLC. Fine, P. G. (2004). Opioid induced hyperalgesia and opioid rotation. Journal of Pain & Palliative Care Pharmacology, 18 (3), 75–79. Green, T., Serrano, J., Licari, A., Budman, S., & Butler, S. (2009). Women who abuse prescription opioids: Findings from the Addiction Severity Index–Multimedia Version Connect prescription opioid database. Drug and Alcohol Dependency, 103, 65–73. Holden, J., Jeong, Y., & Forrest, J. (2005). The endogenous opioid system and clinical pain management. AACN Clinical Issues, 16(3), 291–301. Huff man, J., & Kunik, M. (2000). Assessment and understanding of pain in patients with dementia. The Gerontologist, 40(5), 574–581. Inturrisi, C., & Lipman, A. (2010). Opioid analgesics. In S. Fishman, J. Ballantyne, & J. Rathmell (Eds.), Bonica’s management of pain (pp. 1172–1180). Philadelphia, PA: Lippincott Williams & Wilkins. James, I., O’Brien, C., & McDonald, C. (2010). A randomized, double blind, double dummy comparison of the efficacy and tolerability of low-dose transdermal buprenorphine (Butrans seven day patches) with buprenorphine sublingual tablets (Temgesic) in patient with osteoarthritis pain. Journal of Pain and Symptom Management, 40 (2), 266–278. Katz, N., McCarberg, B., & Reisner, L. (2007). Managing chronic pain with opioids in primary care. Newton, MA: Inflexxion. McLennon, S. M. (2005). Persistent pain management. National Guidelines Clearinghouse. Retrieved from www.guideline.gov Miaskowski, C., Gear, R., & Levine, J. (2000). Sex-related differences in analgesic response. In R. Filligim (Ed.), Sex, gender and pain (pp. 209–227). Seattle, WA: IASP.

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NCCN. (2011). National Comprehensive Cancer Network guidelines: Adult cancer pain. Retrieved October 1, 2011, from National Comprehensive Cancer Network: http:// www.nccn.org/professionals/physician_gls/f_guidelines.asp Nursing 2010 Drug Handbook. (2009). Philadelphia, PA: Lippincott Williams & Wilkins. Nursing 2014 Drug Handbook. (2014). Philadelphia, PA: Lippincott Williams & Wilkins. Pasternak, G. W. (2004). Multiple opioid receptors. Deja vu all over again. Neuropharmacology, 47(Suppl. 1), 312–323. Pasternak, G. W. (2005). Molecular biology of opioid analgesia. Journal of Pain and Symptom Management, 29 (5S), S2–S9. Plosker, G. (2011). Buprenorphine 5, 10, 20 mcg/hour transdermal patch. Drugs, 71(18), 2491–2509. Plosker, G., & Lyseng-Williamson, K. (2012). Buprenorphine 5, 10, 20 mcg/hour transdermal patch: A guide to its use in chronic non-malignant pain. CNS Drugs, 26(4), 367–373. Quill, T. E., Holloway, R. G., Shah, M. S., Caprio, T. V., Olden, A. M., & Storey, J. C. (2010). Primer of palliative care (5th ed.). Glenview, IL: American Academy of Hospice and Palliative Medicine. Stokowski, L. (2010). Opioid-naive and opioid-tolerant patients. Retrieved October 2, 2011, from Medscape Today: http://www.medscape.com/viewarticle/733067_2 Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies. (2009). Results from the 2008 National Survey on Drug Use and Health: National findings. Office of Applied Studies, NSDUH Series H-36, HHS publication number SMA 09-4434. Rockville, MD: U.S. Department of Health and Human Services.

ADDITIONAL RESOURCES Chou, R., Fanciullo, G., Fine, P., Adler, J., Ballantyne, J, Davies, P., . . . Miaskowski, C. (2009). Opioid treatment guidelines: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. The Journal of Pain, 10 (2), 113–130. Institute for Clinical Systems Improvement. (2008). Assessment and management of chronic pain. Bloomington, MN: Author. Retrieved from www.guideline.gov Livlie, R., et al. (2001). Polymorphisms in CYP2D6 duplication-negative individuals with ultrarapid metabolizer phenotype: A role for the CYP2D6*35 allele in ultrarapid metabolism? Pharmcogenetics, 11(1), 45–55. Niesters, M., Dahan, A., Kest, B., Zacny, J., Stijnen Aaets, L., & Sarton, E. (2010). Do sex differences exist in opioid analgesia? A systematic review and meta-analysis of human experiemental and clinical studies. Pain, 151, 61–68. Snyder, S., & Pasternak, G. (2003). Historical review: Opioid receptors. Trends in Pharmacological Sciences, 24(4), 198–205. Stanos, S., Fishbain, D., & Fishman, S. (2009). Pain management with opioid analgesics: Balancing risk and benefit. Physical Medicine & Rehabilitation, 88 (3, Suppl. 2), S69–S99.

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5 Coanalgesic Medications

COANALGESICS FOR ACUTE PAIN Coanalgesics are a varied group of medications that can provide added pain relief when they are combined with NSAIDs or opioids (American Pain Society [APS], 2008). They can have independent analgesic activity for some types of pain and they can counteract select adverse effects of analgesics (APS, 2008). This group of medications was developed originally to treat a wide variety of conditions, such as seizures or muscle spasms, and they were originally intended to control symptoms of the various conditions. However, in many cases, patients reported pain relief when these medications were prescribed for them, leading health care providers to consider their additional application for pain relief as off label usage. Although some classes of these medications are not used for acute pain, there are some that can be used effectively, such as muscle relaxants. Some of these medications are being used to treat pain on an off-label basis. If pain has been determined to have a neuropathic source, medications such as antidepressants, antiseizure medications, or topical medications such as Lidoderm patches can be tried to see if there is any definitive benefit for relieving the pain. An example of this is neuropathic pain in a patient who has a large amount of tissue damage from surgery or swelling where nerves are being compressed, causing additional pain. Medications that are considered to be coanalgesics for pain management include: ■ Antidepressants ■ Anticonvulsants ■ Muscle relaxants ■ Topical agents ■ Cannabinoids ■ n-methyl-d-aspartate (NMDA) receptor blockers ■ Alpha-2 adrenergic agonists ■ Benzodiazepines ■ Antispasmodic agents ■ Stimulants (APS, 2008) 87

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88 5. Coanalgesic Medications Although these medications were not developed for pain control, they have been used for adjunct pain relief and found to be effective. For some medications such as gabapentin, pregabalin, and duloxetine, the pain application became so prevalent that the manufacturers sought and received Food and Drug Administration (FDA) approval for use in pain management. One condition for which these medications can provide effective primary pain relief is fibromyalgia. Many patients with neuropathic pain benefit significantly from the addition of one or more of these agents to help decrease pain. Since many patients with chronic pain are depressed, the use of antidepressants has improved the quality of pain relief and has enhanced sleep for many of these patients. When the World Health Organization (WHO) Ladder was developed with medication choices for pain management (see Chapter 3), the focus was on dividing different types of opioid medications. However, the ladder also includes adjuvant medications, coanalgesics, on each step of the ladder. The broad classes of these medications are listed, but no specific medications are listed, so the choice of coanalgesic is patient dependent (Dalton & Youngblood, 2000). Trying to group these medications into a single class of coanalgesics is difficult. They all have such different mechanisms of action and applications. These medications can enhance the effect of opioids or other medications being used for pain relief, or they can stand alone as single-agent pain relievers (APS, 2008). Some of the benefits of using these medications include: ■ Enhanced pain relief ■ Allow lower doses of opioids (opioid-sparing effect) ■ Management of refractory pain ■ Reduced side effects of opioids related to opioid sparing (APS, 2008) Commonly used coanalgesics include: ■ Acetaminophen ■ Ibuprofen or naproxen ■ Celecoxib ■ Gabapentin and pregabalin ■ Duloxetine ■ Topical lidocaine and capsaicin ■ Cyclobenzaprine, metaxalone ■ Diazepam, alprazolam (APS, 2008) No matter which medication is selected or combined, each patient’s comorbidities need to be assessed and evaluated before adding a new medication to the pain management medication regimen. The following sections will discuss different classes of coanalgesic that can be used for additional pain relief.

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Antidepressant Medications

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ANTIDEPRESSANT MEDICATIONS Antidepressant medications are classed into several different types: ■ Tricyclic ■ Selective serotonin reuptake inhibitors (SSRI) ■ Selective serotonin norepinephrine reuptake inhibitors (SNRI) Antidepressant medications have several different mechanisms of action. The tricyclic antidepressants (TCAs) such as amitriptyline inhibit presynaptic uptake of norepinephrine and serotonin, as do the SNRIs such as duloxetine. Other less-studied actions for TCAs include mild opioid action at the mu binding sites, sodium and calcium channel blockade, NMDA site antagonism, and adenosine activity (Lynch & Watson, 2006). SSRI medications such as fluoxetine inhibit serotonin at the presynaptic junction site (Ghafoor & St Marie, 2009). The effect of this inhibition decreases the ability of the pain stimulus to be transmitted higher up the central nervous system (D’Arcy, 2007). These medications are most commonly used as adjunct medications for neuropathic pain, such as postherpetic neuralgia, painful diabetic neuropathies, and neuropathic syndromes (Lynch & Watson, 2006). They are also good adjuncts in patients with cancer and neuropathic pain when opioids have provided suboptimal pain relief (APS, 2008). Tricyclic Antidepressants (TCAs) Common TCAs

Starting Dose

Effective Dose

amitriptyline (Elavil)

10–25 mg hs

50–150 mg hs

desipramine (Norpramin)

10–25 mg hs

50–150 mg hs

nortriptyline (Pamelor)

10–25 mg hs

50–150 mg hs

Source: APS, 2008.

The TCAs were at one time the first-line treatment for neuropathic pain such as postherpetic neuralgia or postmastectomy pain syndromes. The starting doses are low, 10 to 25 mg titrated up to 150 mg per day (APS, 2008; Wallace & Statts, 2005). Escalating to higher doses to obtain an additive effect for pain relief should take place every 3 to 7 days (Chen, Lamer, Rho, Marshall & Sitzman, 2004). The pain management doses are lower than the antidepressant doses of 150 to 300 mg per day. Of note, the pain relief action of these medications is independent of any effect there may be on mood (Lynch & Watson, 2006). A meta-analysis of the TCA medications indicates that TCAs are effective for use in treating neuropathic pain (APS, 2008). Elavil is the best known and most studied of the TCAs. It is also a primary recommendation for the treatment of fibromyalgia pain (D’Arcy & McCarberg, 2005).

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90 5. Coanalgesic Medications Analgesic response is usually seen within 5 to 7 days (APS, 2008). Adverse effects for TCAs include: ■ Sedation ■ Dry mouth ■ Constipation ■ Urinary retention ■ Orthostatic hypotension ■ Anticholinergic side effects ■ Caution in patients with heart disease, symptomatic prostatic hypertrophy, neurogenic bladder, dementia, and narrow-angle glaucoma ■ Increased suicide behavior in young adults (Institute for Clinical System Improvement [ICSI], 2008) These side effects make the medications undesirable for use in the elderly, especially when they are used in combination with opioid analgesics. Additionally, TCAs can increase the risk for cardiac arrhythmias in patients with underlying conduction abnormalities. Not indicated for use in children (Nursing 2014, 2014). Although these drugs are cheap and readily available, they do have some very significant adverse effects. At the opposite end of the spectrum, they also have the best profile for use in treating neuropathic pain conditions. However, each patient being considered for TCAs should have a thorough assessment for any risk factors such as cardiac conduction abnormalities. When starting TCA therapy, the current recommendation is to screen all patients over 40 years of age with an electrocardiogram (ECG) to evaluate the patients for conduction abnormalities (APS, 2008). TCA medications are not recommended for use in elderly patients due to the high incidence of undesirable side effects and the potential for increased fall risk related to early morning orthostatic hypotension (American Geriatrics Society, 2002; Lynch & Watson, 2006). The biggest benefits of using TCAs for pain relief are improved sleep (Wilson et al., 1997) and the relief of neuropathic pain; that is, pain that is described by patients as burning, shooting, or painful numbness (D’Arcy, 2007). When caring for a patient who is taking TCAs as adjuvant pain medication, health care providers should be aware of the potential for early morning orthostatic hypotension and caution patients to sit on the side of the bed before trying to stand. Some patients complain of sleepiness with these medications. If this is problematic, the patient should be instructed to take the medication earlier in the evening rather than at bedtime, hoping to decrease the early morning sedation that can be experienced. For the dry mouth associated with TCA use, hard candies or gum can ease the dry feeling.

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Patients should always be told the rationale for prescribing an antidepressant medication for pain so they are comfortable taking the medication. The onset of analgesic effect may take up to 2 weeks, and patients should be encouraged to extend a trial of these medications to this period of time to see if analgesia occurs. Selective Serotonin Reuptake Inhibitors (SSRIs) Common SSRIs

Starting Dose

Effective Dose

paroxetine (Paxil)

10–20 mg daily

20–40 mg daily

citalopram (Celexa)

10–20 mg daily

20–40 mg daily

Source: APS, 2008.

Of all three groups of antidepressants, the SSRI group has the poorest profile for pain relief (APS, 2006). When compared to placebo, these medications did not have any significant advantage for pain relief. Given the lack of efficacy for pain relief of these medications and the profile of side effects—sexual dysfunction, anxiety, sleep disorder, and headache—SSRIs are not medications that should be given unless there is a specific indication for use. The recommended use for this group of medications is for patients who have concurrent depression, anxiety, or insomnia (APS, 2008). Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) Common SNRIs

Starting Dose

Effective Dose

venlafaxine (Effexor)

37.5 mg daily

150–225 mg daily

duloxetine (Cymbalta)

20 mg daily

60 mg daily

Source: APS, 2008.

The pain relief mechanism of the SNRI group of antidepressants is the inhibition of serotonin and norepinephrine at therapeutic doses (APS, 2008). The SNRI medications do not have the same anticholinergic side effect profile as the TCA medications. They are effective for a variety of neuropathic pain conditions such as diabetic neuropathy, postherpetic neuralgia, and atypical facial pain (Lynch & Watson, 2006). Venlafaxine has shown an effect on hyperalgesia and allodynia, both preventing the occurrence and decreasing the pain (APS, 2008; Wallace & Staats, 2005). Effective doses for venlafaxine for pain relief range from 150 to 225 mg, with a starting dose of 37.5 mg. Duloxetine has received FDA approval for treating painful diabetic neuropathy (PDN). For duloxetine, the starting dose of 20 mg per day

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92 5. Coanalgesic Medications may decrease the incidence of side effects, with pain relief being experienced at a dose range from 60 to 120 mg per day. Careful titration of the medications and slow dose increases will help decrease some of the side effects such as somnolence, nausea, and sweating. There have been no identified increased cardiovascular risks associated with the use of duloxetine (APS, 2008). There are some drawbacks with both venlafaxine and duloxetine. There is an increased risk for suicidal ideation and behavior in children and adolescents with major depressive disorders, and Effexor and Cymbalta are not approved for pediatric patients. Care should also be taken with patients who have liver disease or use alcohol consistently (Cymbalta PI, NPPR prescribing information. Nurse Practitioner Prescribing Reference, Winter 2006-2007 available at www.PrescribingReference.com) There is also the potential for the development of sick serotonin syndrome, when patients taking SNRI medications take other medications that affect serotonin production, such as SSRIs. Cardiac changes are also possible with AV block and increases in blood pressure (Lynch & Watson, 2006). Five percent of venlafaxinetreated patients had changes on follow-up ECGs (APS, 2008). As a result, patients who are taking venlafaxine who also have diabetes mellitus, hypertension, hypercholesterolemia, or are currently smoking should have ECG monitoring while on the antidepressant medication (APS, 2008). Patients who are taking these medications for adjunct pain relief should have regular blood pressure screenings and should be assessed regularly for any signs of cardiac changes. Careful dose tapering should take place when these medications are being discontinued to avoid discontinuation syndrome, insomnia, lethargy, diarrhea, nausea, dizziness, or paresthesia (APS, 2008).

ANTICONVULSANT MEDICATIONS Anticonvulsants are commonly used to treat neuropathic pain of many different types, such as postherpetic neuralgia, PDN, and trigeminal neuralgia (APS, 2006). The original premise for use was that if these medications could control the erratic neuronal firing or seizures they could be applied for controlling neuronal discharge from pain stimuli. Research has shown that this is essentially true and one of the primary mechanisms of these medications is to reduce neuronal excitability and spontaneous firing of cortical neurons (APS, 2008). When applied to pain management, these drugs are thought to decrease the neuronal firing after nerve damage for neuropathic pain and to decrease neuronal sensitization (APS, 2008).

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Anticonvulsant Medications Common Anticonvulsants

Starting Dose

gabapentin (Neurontin)

100–300 mg hs

300–1200 mg TID

Effective Dose

pregabalin (Lyrica)

150 mg daily

300–600 mg daily

carbamazepine (Tegretol)

100–200 mg daily 300–800 mg BID

topiramate (Topamax)

25 mg daily

100–200 mg BID

phenytoin (Dilantin)

300 mg hs

100–150 mg TID

Source: APS, 2008.

Anticonvulsant agents are commonly used for treating neuropathic pain. Gabapentin is one of the medications used to treat a multitude of neuropathic pain syndromes but it is particularly effective with postherpetic neuralgia, diabetic neuropathy, phantom limb pain, Guillain–Barré syndrome, neuropathic cancer pain and acute and chronic spinal cord injury (APS, 2008; ICSI, 2008). Syndromes that do not respond to gabapentin are HIV-related neuropathy and painful peripheral chemotherapy-induced neuropathies (APS, 2008). Both gabapentin and pregabalin act by blocking calcium channels on neurons, the alpha 2-delta subunit specifically, thereby reducing the release of glutamate, norepinephrine, and substance P (APS, 2008). Because the drugs are excreted renally, dose reductions are advised for patients with renal impairment. The one drawback to gabapentin is the length of time needed to reach effective dose strength. Since medication response is patient dependent, it may takes weeks or months to reach a dose of gabapentin that will provide pain relief. Pregabalin as an alternate option can provide a faster response for pain relief since therapeutic doses can be given earlier in the treatment. For acute pain, gabapentin (Neurontin) and pregabalin have demonstrated an opioid-sparing effect of up to 60% when the medications are given preoperatively at doses of 300 mg to 1200 mg (Neurontin). The drawback is the increased sedation that has also been reported. Only gabapentin, not pregabalin, should be given at doses of 1200 mg. The older anticonvulsants such as phenytoin (Dilantin) have not been studied for pain relief as fully as the newer gabapentin medications and thus have only weak evidence for their use as coanalgesic medications for pain. There is a need for further research data. In one meta-analysis (McQuay et al., 1995, in APS, 2008), four anticonvulsants including phenytoin, carbamazepine, clonazepam, and valproate determined that these anticonvulsants were effective for relieving the pain of trigeminal neuralgia, diabetic neuropathy, and migraine prophylaxis.

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94 5. Coanalgesic Medications Given the high profi le for serious adverse side effects, the new gabapentin medications are indicated as first-line drugs for treating neuropathic pain (APS, 2008). One of the major drawbacks to anticonvulsant medications is their high profile for adverse side effects. These include: ■ Somnolence ■ Dizziness ■ Fatigue ■ Nausea ■ Edema ■ Weight gain ■ Stevens–Johnson syndrome ■ Increased risk of suicidal behavior or ideation ■ Aplastic anemia and agranulocytosis (ICSI, 2008) The serious nature of the adverse side effects of this class of medications makes it imperative that when starting these medications a full baseline history is taken from the patient. Careful monitoring is required and the patient should be instructed to report the occurrence and severity of any adverse effect if it happens.

TOPICAL ANALGESICS

Lidocaine 5% Patch (Lidoderm) When the patient has a specific tender point or has an area of pain that is limited, it is tempting to use a type of pain relief that will affect only the painful area. The lidocaine patch (5%) is a soft flannel-backed patch with 5% lidocaine that can be applied over the painful area. It has an indication for use with postherpetic neuralgia and has been studied in PDN, complex regional pain syndrome, postmastectomy pain, and HIV-related neuropathy (APS, 2008). The patch is designed to be used for 12 hours on and 12 hours off, though patients have worn the patch for 24 hours with no ill effects (APS, 2008; D’Arcy, 2007) The maximum dose of Lidoderm is up to three patches at one time. The patches should be replaced daily and placed only on intact skin. Active serum levels of lidocaine with patch use are minimal (APS, 2008). Patients tolerate this type of therapy very well, and since it is noninvasive, should the patient not like the feeling of the patch or effect, the patch can be easily removed. The one side effect from the Lidoderm patch that has been reported is rare instances of skin irritation at the site of patch application.

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Muscle Relaxants

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Capsaicin Cream (Zostrix) Capsaicin topical cream, derived from hot peppers, can restructure the way the C-fiber neurons transmit pain stimuli. It is sold over the counter as Zostrix cream and is available in two different strengths. The neuropathic conditions for which this cream has been most helpful include postmastectomy pain, other peripheral neuropathic conditions, and neck and arthritis pain (APS, 2008). When the cream is applied it causes a burning sensation in the application area. The patient should be warned to expect the sensation. Gloves should be used to apply the cream, and other parts of the body, particularly the eyes, should not be touched until all the cream is removed from the hands. Th is treatment technique requires a dedicated patient who is willing to persevere and apply the cream three to four times per day for 2 weeks to see if there is any analgesic benefit. A new 8% capsaicin patch called Quetensa is used for postherpetic neuralgia. It needs to be applied by a health care provider who has been trained in the technique. Local anesthesia is applied over the site of the pain, the patch is applied for 1 hour, and then the patch is removed. This form of capsaicin can provide up to 12 weeks of pain relief.

Targeted Analgesic-Diclofenac Epolamine Patch (Flector) The Flector patch is a nonselective NSAID patch that is applied directly over the site of the pain on intact skin. It is especially useful for strains and sprains. The recommended dose is one patch to the affected area BID (Nursing 2014 Drug Handbook, 2014). Because this is a new use for NSAIDs, the research support is limited and data on systemic absorption are open to change when clinical usage increases. Currently, the medication has the same black box warning of all nonselective NSAIDs. There are compounded gels and over-the-counter NSAID gel formulations as well. These can be very effective if used as directed in the prescribed area. However, with continued use and application over large areas, there is an increased potential for systemic absorption. Patients are advised to use the application card supplied with the medication and wear gloves when applying the gel (Nursing 2014 Drug Handbook, 2014).

MUSCLE RELAXANTS Muscle relaxants are a good addition to a pain regimen, such as for low back pain where muscle spasms occur regularly. They are also useful for conditions such as fibromyalgia, where cyclobenzaprine is used as a first-line

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96 5. Coanalgesic Medications option (APS, 2005; D’Arcy & McCarberg, 2005). The group of medications generically called skeletal muscle relaxants consists of several different groups of medications: benzodiazepines, sedatives, antihistamines, and other centrally acting medications (APS, 2008). Skeletal Muscle Relaxants Common Muscle Relaxants

Starting Dose

Effective Dose

cyclobenzaprine (Fexeril)

5 mg TID

10–20 mg TID

orphenadrine (Norflex)

100 mg BID

100 mg BID

tizanidine (Zanaflex)

2 mg hs

Variable

metaxalone (Skelaxin)

400 mg TID–QID

800 mg TID–QID

methocarbamol (Robaxin)

500 mg QID

500–750 mg QID

antispasmodic (Baclofen)

5 mg TID

10–20 mg TID

benzodiazepine (Diazepam)

1 mg BID

2–10 mg BID-QID

Other:

Source: APS, 2008.

Although there is no indication that these medications relax skeletal muscles, they are commonly used for spasm and muscle tightness (APS, 2008). After 1 to 2 weeks, the action of the medication shifts to a central activity rather than skeletal muscle activity (APS, 2008). The most common side effect of this group of medications is sedation. If they are being use concomitantly with an opioid analgesic the sedative effect is cumulative. There is the potential for abuse in patients who are predisposed to this problem so intermittent or short-term use is advised.

OTHER COANALGESICS There are a variety of other medications that can be used as coanalgesics, ranging from cannabinoids and dronabinol, which are recommended for neuropathic pain from multiple sclerosis, to NMDA receptor blockers, ketamine, dextromethorphan, and amantadine, used for centrally mediated neuropathic pain and hyperalgesia. These agents are not recommended for first- or second-line use, but rather for patients who have failed all other attempts for pain relief. These medications have a high profi le for little research support and more is learned from anecdotal and single-study support.

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These medications also have a high profile for significant adverse side effects. Dronabinol use can cause cognitive impairment, psychosis, and sedation (APS, 2008). The NMDA receptor blockers have significant adverse side effects as well (ketamine-hallucinations, memory problems, abuse potential); amantadine and dextromethorphan have less severe side effects (dizziness, insomnia, and nausea; Nursing 2014 Drug Handbook, 2014). When considering using a coanalgesic, the health care provider needs to fully assess the patient and consider all the comorbidities and potential drug–drug interactions. The use of these medications is highly individual and doses may vary according to the patient’s ability to tolerate the medications. Starting a lower dose and escalating slowly can help reduce the seriousness of the side effects. Since analgesic effect can take time to become apparent, patients should be encouraged to use these medications for at least 2 weeks before deciding they are not effective for pain relief. Case Study Susan is an 86-year-old patient who is admitted with intractable pain after a herpes zoster infection. She is moaning and rocking back and forth, and crying out when you see her. She pleads with you, “Please, please make this pain stop.” When you examine the painful area it is the site of a healed rash across the thorax, on one side. Her family tells you she has not slept in weeks and none of the pain medications work. She can’t even stand to have clothes touch her skin, so she has stopped wearing a bra and blouse. The current pain medications are Vicodin and ibuprofen. Pain is 10/10 in intensity. How will you manage her pain?

Questions to Consider 1. What type of opioids will you use: more orals, IV, patientcontrolled analgesia, or epidural? 2. What is the name of the condition in which pain is experienced when coming into contact with clothing? 3. What types of coanalgesics can you use? 4. Would an interventional pain management option work for Susan? 5. Would you consider using Quetensa?

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98 5. Coanalgesic Medications

REFERENCES American Geriatrics Society. (2002). The management of persistent pain in older persons. Journal of the American Geriatrics Society, 50, S205–S224. American Pain Society. (2006). Pain control in the primary care setting. Glenview, IL: American Pain Society. American Pain Society. (2008). Principles of analgesic use in the treatment of acute and cancer pain. Glenview, IL: Author. Chen, H., Lamer, T., Rho, R., Marshall, K., Sitzman, T., Ghazi, S., & Brewer, R. (2004). Contemporary management of neuropathic pain for the primary care physician. Mayo Clinic Proceedings, 79 (12), 1533–1545. Dalton, J. A., & Youngblood, R. (2000). Clinical application of the World Health Organization analgesic ladder. Journal of IV Nursing, 23 (2), 118–124. D’Arcy, Y. (2007). Pain management: Evidence-based tools and techniques for nursing professionals. Marblehead, MA: HCPro. D’Arcy, Y., & McCarberg, B. (2005). New fibromyalgia pain management recommendations. ACNP Journal for Nurse Practitioners, 1(4), 218–225. Ghafoor, V., & St. Marie, B. (2009). Overview of pharmacology in core curriculum for pain management nursing. Indianapolis, IN: Kendall Publications. Institute for Clinical System Improvement. (2008). Assessment and management of chronic pain. Retrieved from www.guideline.gov Lynch, M., & Watson, C. (2006). The pharmacotherapy of chronic pain: a review. Pain Research & Management: The Journal of the Canadian Pain Society, 11(1), 11–38. Nursing 2014 Drug Handbook. (2014). Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins. Wallace, M., & Staats, P. (2005). Pain medicine & management. New York, NY: McGraw-Hill. Wilson, P., Caplan, R., Connis, R., Gilbert, H., Grigsby, E., Haddox, D., … Simon, D. (1997). Practice guidelines for chronic pain management: A report by the American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section. Anesthesiology, 86(4), 995–1004.

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6 Complementary and Alternative Medicine Techniques for Managing Pain

Complementary and alternative medicine (CAM) and integrative techniques are attractive to patients with all types of pain. These treatment options do not require a prescription, the patient controls their use, and many have no cost or have free classes that are offered in community centers or cancer treatment centers. Women like these techniques because they allow them to add a nonmedication element to pain control. The focus of this type of therapy is to enhance the patient’s quality of life while helping to lessen pain and symptom burden. Some of the therapies provide relaxation while others help patients fight fatigue and control pain. Many patients do not think to tell their health care provider about their use of CAM therapies, and many health care providers do not ask about them. Many women are too shy to tell their physician that they are using something that he or she has not prescribed to lessen pain. A question about CAM can be included in the assessment process if the brief pain impact questionnaire (BPIQ) is being used for pain assessment. This means that CAM is being used more widely than most health care providers know, and there is very little discussion about the use of CAM therapies between health care providers and patients. In order to provide holistic care for patients with pain, discussing the use of a variety of techniques and developing a multimodal plan of care can produce better outcomes and greater patient satisfaction. For many patients, the use of CAM seems very comfortable. The interventions are considered to be gentle and noninvasive, and most patients will supplement their traditional treatments with one or more CAM therapies. While using CAM therapies, the patient is in control of the option and can sense the improvement in physical and mental well-being provided by therapies such as massage, yoga, music, and relaxation therapy.

99

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100 6. Complementary and Alternative Medicine Techniques for Managing Pain

DIFFERENCES IN TYPES OF THERAPY The National Center for Complementary and Alternative Medicine (NCCM) located at the National Institutes of Health (NIH) has started to examine all of the techniques, therapies, and herbal supplements that are being used in CAM therapy. They have reviewed the literature for CAM and determined that in some cases there is not enough evidence to make a solid practice recommendation, while in other cases there is enough research to support recommendation of some CAM practices. Since the positive effects CAM can have on patient outcomes are becoming more evident, more studies are being done to support the use of various CAM therapies. CAM in general is defined as “a group of diverse medical and health care systems, practices, and products not presently considered to be a part of conventional medicine” (American Pain Society [APS], 2006; Stoney, Wallerstedt, Stagl, & Mansky, 2009; Yates et al., 2005). These nutritional supplements, techniques, and therapies are really meant to enhance curative therapy—not replace it. This highlights the need for practitioners to ask patients about their use of CAM and educate patients about the appropriate use of the techniques. Common definitions for CAM include: Complementary: Techniques or additional therapies that are used in conjunction with recognized mainstream medical practices; for instance, using yoga or music with medication. Alternative: This is an approach that forgoes recognized medical therapy and substitutes another form of therapy; for example, a patient who forgoes chemotherapy in favor of nutritional supplements and vitamins. This type of practice can be harmful either directly or indirectly when patients opt to delay or not choose recommended therapies that are backed by research (Cassileth & Gubili, 2009). Integrative: This is a more inclusive term that CAM practitioners understand as the use of pharmacotherapy and nonpharmacologic methods to enhance medical treatment. The term was first used by Dr. Andrew Weil and seems to be the most common term used for CAM therapies (National Center for Complementary and Alternative Medicine [NCCAM], 2004). The inclusion of both sides of the treatment options would be a preferred practice for all patients (Bardia, Barton, Prokop, Bauer, & Moynihan, 2006). The NCCAM has divided CAM therapies into four divisions: 1. Body-based therapies that include the use of massage, yoga, exercise, and acupuncture

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2. Mind–body approaches that include mind–body techniques such as cognitive behavioral approaches, relaxation, biofeedback, meditation, distraction, imagery, and self-hypnosis 3. Energy medicine that includes Reiki, therapeutic touch (TT), and healing touch 4. Diet and nutritional approaches that use diet, herbs, and vitamin supplements Some of the techniques are simple and easy to use and require little cost and training, such as relaxation. Others such as self-hypnosis or yoga require training and practice to be effective adjuncts for pain relief. Some of the more complex therapies require a trained practitioner to administer the treatment, such as Reiki or acupuncture.

USE OF CAM WITH WOMEN CAM is an attractive option for women. Many techniques are costfree and can be used on the patient’s personal schedule. Many gyms or wellness centers provide child care while patients participate in classes. Patients with connective tissue diseases, osteoarthritis, or fibromyalgia can benefit from adding CAM techniques to their treatment regimen. In a systematic review of yoga use in 1,626 patients, yoga was found to be acceptable and safe while it improved pain and functional outcomes (Ward, Stebbings, Cherkin, & Baxter, 2013). Exercise during pregnancy is beneficial in several areas. Healthy pregnant women can engage in moderate-intensity, low-impact aerobic exercise at least three times per week unless contraindicated (Nasciemento, Surita, & Cecatti, 2012). Benefits for exercise during pregnancy include higher cardiorespiratory fitness, prevention of urinary incontinence and low back pain, and decreased symptoms of depression (Nascimento et al., 2012). CAM use appears to be very common among women with breast cancer. CAM is used more widely than suspected by most oncologists or primary care practitioners who see patients with chronic cancer pain. Some studies indicate that the prevalence of CAM in the cancer population ranges from 54% to 77% (Smith, 2005). In a study of 752 newly diagnosed patients with cancer, 91% reported using at least one form of CAM for symptom management during their treatment period (Yates, Mustian, & Morrow, 2005). The most commonly used CAM therapies in this study were prayer, relaxation, and exercise (Yates et al., 2005). Of the 752 patients, 57% had discussed the use of the CAM therapies, including diet, massage, and herbal medicine, with their oncologist or primary care

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102 6. Complementary and Alternative Medicine Techniques for Managing Pain physician (Yates et al., 2005). Studies indicate that the patients receiving active treatment who are most likely to use CAM are: ■ Women ■ Patients with a high school diploma or some college education ■ Undergoing chemotherapy rather than radiation ■ Diagnosed with breast cancer over other types of cancer Many patients feel that adding some form of CAM to their treatment regimen reduces anxiety and pain while providing a holistic approach to treating their pain. There are practice barriers to using CAM as an adjunct for pain relief. Many physicians do not have enough accurate information about CAM therapies and do not understand how to use them (Bardia et al., 2006). The research base for some of these therapies is not fully expanded, and some research indicates that some therapies perform little better than placebo (Bardia et al., 2006; Caasileth & Gubili, 2009). Guidelines such as those released by the National Comprehensive Cancer Network mention the use of CAM but fail to provide evidence-based recommendations for clinical use. Despite the lack of research support and lack of knowledge and information about these therapies, CAM therapies continue to be popular with patients. Of patients who used CAM, 86% indicated they were satisfied with the outcomes of the therapy, as well as satisfied with the therapy itself (Cassileth & Gubili, 2009). The NCCAM project of research analysis will hopefully provide some concrete support for CAM and help define the best practices related to implementing CAM into the clinical setting. This research analysis may help provide patients with the ability to understand how to make better use of holistic practices to achieve a better quality of life.

Clinical Pearl

W omen enjoy the use of CAM therapies and par cipate in a wide variety of op ons including exercise, yoga, massage, relaxa on, and energy treatments.

BODYBASED THERAPY Body-based therapies are those that are focused on moving the body or providing a treatment physically. Some of the common body-based therapies that will be discussed in this chapter are: ■ Acupuncture ■ Massage ■ Yoga ■ Aromatherapy ■ Magnets/laser therapy

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Body-Based Therapy

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Although this does not address all physical therapies, it is a good representation of what patients are asking about and using. Some of the information will be for pain in general and other information will be specific to a particular disease or condition.

Acupuncture Acupuncture comes to modern medicine from ancient Chinese healers who used the insertion of needles into the patient’s body at specific points to regulate and restore proper function to Qi, or the body’s vital energy. Once the needles are placed in specific locations along meridians on the patient’s body, they can be manipulated by hand or electrically stimulated to release the body’s neurotransmitters to decrease pain (D’Arcy, 2011). The treatment goal is to open up any of the body’s blocked energy points, called chakras, and allow the body’s natural energy to flow. Some patients with breast cancer progress to having bone metastases. In a critical review article the use of acupuncture for the relief of bone pain was cited as effective. Bone pain can be the result of chemical mediators such as cytokines from tumor cells, increased pressure within the bone, microfractures, periosteal stretching, muscle spasms, or nerve compression or infiltration (Paley, Bennett, & Johnson, 2010). Rationales for using acupuncture for relief of bone pain include: ■ Stimulation of A-delta fibers in muscle and skin, which in turn results in the release of inhibitory enkephalins and reduce neuronal activity ■ Use of electrical currents during acupuncture has been shown to reduce both sensitization of postsynaptic receptors and neurotransmitter release (Paley et al., 2010) There is a low incidence of side effects reported with acupuncture, and the most serious reported were infections, blood-borne diseases, and internal organ and tissue injury (Lu & Rosenthal, 2010).

Massage Massage can take many forms, including deep tissue, Swedish, Rolfing, and reflexology, among others. For pain management, massage has been used for low back pain, neck pain, headaches, and other chronic pain conditions. NCCAM defines massage as a form of manual therapy applied by a massage therapist using his or her hands to press, rub, and otherwise manipulate the muscles and soft tissue in multiple areas of the body (NCCAM, 2004; Stoney et al., 2009). The mechanism of action for massage is thought to be the stimulation of the endogenous opiate system as well as the release of oxytocin (Stoney et al., 2009). It can also increase oxygenation and blood

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104 6. Complementary and Alternative Medicine Techniques for Managing Pain flow in the area being massaged, which tends to lengthen and relax muscles (NCCAM, 2004). Massage not only relieves pain, but it can also promote relaxation, relieve tension and anxiety, and decrease nausea for cancer patients (Cassileth & Gubili, 2009). Some massage therapists do lymph drainage on cancer patients, most commonly breast cancer patients. Lymphedema is the subcutaneous collection of edematous fluid and adipose tissue that can be very uncomfortable (Warren, Brorson, Borud, & Slavin, 2007). For the patient with breast cancer, the fluid collects on the operative side. The use of a compression sleeve can reduce the swelling, but manual controlled compression of the fluid is performed by physical therapists or massage therapists. Lymphedema can also be an unwanted side effect of normal massage therapy. Avoiding the quadrants where treatment or surgery has occurred, using a lighter touch, and monitoring the patient for the beginning of swelling can avoid the unpleasant consequence of lymphedema for patients with cancer.

Aromatherapy Aromatherapy uses aromatic compounds to promote health and healing (Hirsch, 2008). The most common use of these substances is through inhalation. The olfactory sense is very unique and has a connection through the olfactory nerves to the cortex of the brain. Within the olfactory bulb are neurotransmitters such as glutamate, aspartate, cholecystokinin, luteinizing hormone-releasing hormone (LHRH), and somatostatin (Hirsch, 2008). The release of neurotransmitters affects the action of the olfactory bulb, the limbic system, and the olfactory tracts, affecting behavior and mood (Hirsch, 2008). The presence of pleasant odors can also provide a distraction to sensory input such as pain. Aromatherapy odors that have been used for pain relief include: ■ Chamomile ■ Clary sage ■ Eucalyptus ■ Jasmine ■ Lavender ■ Lemon ■ Mint ■ Combinations of geranium, lavender, and roman chamomile ■ Combinations of lavender, bergamot, sweet orange, and marjoram (Hirsch, 2008) These scents can be provided using the herbs themselves or the essential oils, which are more potent. Aromatherapy can be effectively combined with massage to enhance the overall effect for the patient. For some patients

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aromatherapy may not be an option, such as for asthmatics or patients with breathing disorders who have reactions to certain scents.

Magnets The benefit of magnets is said to be increased circulation into the area where the magnet is applied or used. There is, however, little research evidence on the technique, and magnets are not recommended as an adjunct technique to relieve pain (D’Arcy, 2011).

MINDBODY APPROACHES

Yoga Yoga is a popular form of exercise in the United States. The term yoga is derived from the Sanskrit word yug, which means to yoke, bind, or join (Carlson & Bultz, 2008; Distasio, 2008).This joining was felt to be a joining of the person with the larger universe. In reality, modern yoga is a combination of physical poses with meditation (Carlson & Bultz, 2008). To perform yoga the patient uses movement, proper breathing, and posture. There is also an element of social support since most yoga is done in groups. There are at least five different forms of yoga, with some forms more rigorous and others consisting of more gentle posturing and movements. Patients can achieve many positive outcomes by practicing yoga. Nurses should be aware of the availability of yoga classes in their area and offer patients information on how to join local yoga programs.

MINDBODY THERAPIES

Cognitive-Behavioral Therapy (CBT) Mind–body therapy encompasses techniques that include imagery, hypnosis, and coping skills. Some of the techniques are especially helpful for procedure-related pain. A meta-analysis of CBTs indicated that these therapies performed as well as, if not better than, placebo or no treatment (APS, 2005). Not all patients are open to trying these techniques. For those patients willing to invest the time and energy into learning how to use these methods, a good outcome can be expected. Women’s time and energy to devote to these techniques may vary. For more compromised patients with less energy, using relaxation tapes or music might be a better fit for their condition.

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106 6. Complementary and Alternative Medicine Techniques for Managing Pain

Relaxation There are various levels and types of relaxation techniques that can be used to help control pain, such as: ■ Regulation of breathing, which can lead to decreased respiratory efforts ■ Relaxation tapes for progressive relaxation ■ Relaxation exercises Relaxation techniques are effective for decreasing pain in patients. These techniques result in the reduction of physical tension, muscle relaxation, and the promotion of emotional well-being (NCCAM, 2004). Major benefits of relaxation include an improved sense of well-being and higher scores on quality-of-life scales (Dillard & Knapp, 2005). When patients use relaxation they are asked to either progressively relax their muscles starting from the top of the body and progressing to the lower extremities, or they can focus on one process such as controlling breathing. There are prerecorded tapes with relaxation exercises that patients can purchase to use at certain times of the day, such as when they feel stress building or as a help for relaxing to fall asleep. The patient can keep track of progress with a pain diary or journal. In a study comparing progressive relaxation and massage for reducing pain, progressive muscle relaxation demonstrated greater benefit and pain relief (Anderson, Cohen, & Mendoz, 2006). Other studies had mixed results, but there was a positive correlation between relaxation techniques and improved quality of sleep (Elkins, Fisher, & Johnson, 2010).

Imagery Imagery is a form of relaxation using a mental image. It involves the use of the mind to achieve a clinical goal such as a slowed heart rate (Carlson & Bultz, 2008). When a patient uses imagery, she is encouraged to create a peaceful or soothing image. The patient enjoys the feeling of comfort that the scenario provides. Images are created by the patient or provided by tapes if the patient has difficulty developing the mental images. For example, a patient could be asked to picture a lovely warm beach. The patient is asked to hear the ocean and feel the sun on her face. She can smell the sea and feel the breeze. Sea birds can be heard in the background as the surf washes up on the beach. The patient becomes more relaxed as the scene takes over her conscious being. This image is peaceful and pleasant. The patient should choose an image that she can easily call up from memory so that the patient can use the technique very easily when needed for pain relief or stress reduction. Using imagery for pain relief can also include the use of an image that locates the area of pain, such as the abdomen. The patient can picture the abdominal pain as a red or dark color when pain is present. Working with the image, the patient can use relaxation and cognitive restructuring to see

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Mind–Body Therapies

the pain leaving the abdomen; getting smaller in size; or the color turning to a more peaceful, restful blue tone. This type of imagery is slightly more complex, but patients can learn to use it effectively to help decrease pain. Patients using imagery coupled with other cognitive behavioral methods show better pain relief results (APS, 2005). To use imagery effectively the patient should practice in a quiet place where recalling the image is an easier task. Learning to focus on the image can help the patient relax and will distract the patient from the pain stimulus.

Meditation or Mindfulness-Based Stress Reduction Meditation or focusing the mind is a part of several different CBTs, such as relaxation. It can also be combined with yoga where a more contemplative approach is used. The definition of meditation is to focus the mind on a single target or perception (Carlson & Bultz, 2008). Although it is hard to isolate the effect of meditation, mindfulness-based stress reduction has shown positive results in decreasing the patient’s symptom burden (Carlson & Bultz, 2008). Studies among patients have shown that meditation can: ■ Improve sleep ■ Improve quality of life ■ Reduce stress ■ Create a spirit of appreciation for life as a meaningful process ■ Improve immune function ■ Relieve anxiety (Carlson & Bultz, 2008) Although these studies did not involve rigorous research, they do provide insight into the benefits of using a cognitive-behavioral technique such as meditation or mindfulness-based stress reduction to add to the patient’s medication regimen.

Self-Hypnosis Self-hypnosis is a technique that requires training and practice for the patient to use it effectively. It is defined as a natural state of aroused, attentive focal concentration coupled with a relative suspension of peripheral awareness aimed clinically at symptom relief (Carlson & Bultz, 2008). Clinically it is defined as an altered state of consciousness, awareness, and perception (Elkins et al., 2010). The relaxed state induced by hypnosis is very beneficial for aiding in pain relief. In a study of patients undergoing breast biopsy, patients who were placed in the hypnosis intervention group had less pain and distress (Montgomery, Weltz, & Seltz, 2002). In a review of all studies on hypnosis from 1999 to 2006, hypnosis was found to reduce pain and anxiety without side effects

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108 6. Complementary and Alternative Medicine Techniques for Managing Pain while allowing patients to become active participants in their own comfort and well-being (Carlson & Bultz, 2008). For patients who are interested in hypnosis or self-hypnosis, a referral to a local psychologist who works with patients who have pain may be beneficial and add a strong element to the plan of care.

Music/Humor Many patients listen to music to relax or block out noise so they can rest better. To use music as a therapy, the first question should be what type of music the patient prefers. The patient’s selections can be offered using tapes, CD, or radio broadcasts. Humor is also appreciated by patients. Both music and humor can serve as a form of distraction for pain. Laughter can make people feel good and stimulate a feeling of general well-being (Christie & Moore, 2005). Laughter can serve as a coping mechanism, promote relaxation, and stimulate healing (Christie & Moore, 2005). To use humor effectively it is important to know how the patient responds to humor and what the patient finds humorous. Once preferences have been determined, providing funny videos or tapes, recalling funny incidents, looking at a funny card or picture, or just being around happy people can provide benefit. In a study where patients watched either a humorous or nonhumorous video while an extremity was submerged in a water bath, the patients who watched the humorous video had increased pain thresholds for 30 minutes after viewing the humorous video (Carroll et al., 2000). If the patient is open to using music or humor for relaxing and coping, it is a good way to provide a noninvasive form of therapy that most patients enjoy.

ENERGY THERAPIES Oriental cultures have used energy healing for many centuries. The idea of channeling energy from the universe through the patient to open blocked chakras is derived from the concept of Qigong, an external and internal energy life force. In order to use these therapies with patients in modern days, several newer energy therapies were developed to include Reiki, TT, and healing touch (Pierce, 2009). There are some differences in the practices, but the overall concepts have a similar intent: ■ The human body has an energy field that is generated from within the body to the outer world ■ There is a universal energy that flows through all living things and it is available to all of them

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■ ■

Self-healing is promoted through the free-flowing energy field Disease and illness may be felt in the energy field and can be felt and changed by the healing intent of the practitioner (Pierce, 2009) These energy therapies are effective for pain relief and relaxation. Two of the most commonly practiced are Reiki and TT.

Reiki The Reiki practitioner who is performing a therapeutic session on a patient uses the natural energy of the universe and channels it through the patient’s body to unblock chakras. The techniques used by Reiki practitioners were developed and taught by the Buddhist monk Mikao Usui from Japan beginning in 1914 (Pierce, 2009). In basic Reiki, the Reiki practitioner places the hands in specific configurations on the patient’s body to channel the universal energy through the chakras, opening up blocked points. In more advanced levels of practice, a Reiki practitioner transmits energy over a long distance to benefit a specific person (NCCAM, 2004). Reiki has been used in Eastern cultures to ease both the mind and body. There are three levels of Reiki practice. Each level includes some additional form of energy transfer. Even with the basic level, the patient feels relaxed and experiences emotional and physical healing. The Reiki practitioner who channels the energy for the patient also receives benefit, including feeling more relaxed and in tune with his or her own body energy.

Therapeutic Touch (TT) TT originated in the 1970s as collaboration between two women, Dolores Krieger and Dora Kunz. The practice was based on similar concepts as Reiki. Although the two originators hoped that TT would become a part of standard patient care, it has proved more difficult to operationalize than anticipated (Pierce, 2009). At this time, the practice remains a nonstandard addition to patient care, although it is popular in some areas of the country. TT is a form of energy medicine where the practitioner does not touch the patient receiving the therapy, but rather focuses the energy on the patient’s aura. Smoothing the aura by the energy transfer from the practitioner to the patient can help provide healing energy. It is often mistakenly referred to as “laying on of hands,” which has a more religious connotation. The premise of TT is that the practitioner’s healing force transfers or channels energy, thereby positively affecting the patient’s recovery (NCCAM, 2004). As the TT practitioner allows the hands to move over the patient’s aura, blocked energy is identified. Through the practitioner’s hands, healing forces are directed to the area to promote healing and pain relief.

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110 6. Complementary and Alternative Medicine Techniques for Managing Pain There are some studies that indicate greater pain relief with the use of TT in patients with chronic pain and fibromyalgia when compared to patient groups not receiving the energy treatment option (Pierce, 2009). It is difficult to conduct a study with TT because the recipient knows that she is not receiving the actual treatment, but only a sham if they are placed into the placebo arm of the study. Because randomized placebo-controlled studies are not possible with TT, it is difficult to measure the true effect of the practice.

NUTRITIONAL THERAPY Most American homes have some type of home remedy or homeopathic treatment that is used to treat minor aches and pains. Most patients do not think about telling their physician about their home remedies. The reasons for nondisclosure include thinking it is just an over-the-counter herbal supplement and not “true medicine,” or potential embarrassment. It is important to explore the use of these substances during the patient interview, so questioning the patient about use of herbals, supplements, and homeopathic remedies should be a part of the interview and follow-up process. Research indicates that only 40% of patients who are using these substances discuss it with their physicians or health care providers (Miccozzi, 2008). A survey of anesthesiologists in the United Kingdom indicated that 65% felt that there was potential for harmful effects with surgical patients using herbal remedies, and 82% of them felt that they had inadequate knowledge of herbal remedies (Micozzi, 2008). It has also become a bigger issue since reliable resources for information on medication interactions and effects on treatments are limited. In a qualitative study with six focus groups comprised of 6 to 8 patients each already taking herbal remedies, researchers explored the use of herbal preparations, sources of information on the use of these supplements, and what information would be helpful for these patients (Gratus et al., 2009). Findings indicate: ■ Support groups and family and friends are the most common sources of advice on herbal medication ■ Very few patients trust the Internet as a source of information or support ■ Accessible, interpretable, and reliable information materials need to be developed for patients to use in critical decision making regarding the use of herbal medicines (Gratus et al., 2009)

Herbal Supplements To use a botanical agent in an herbal supplement, raw ingredients, juices, resins, or oils are mixed with other materials with questionable quality control. There is a high reliance on the quality of the plant itself, and there

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are questions as to where it was grown and what was applied to the plant, such as herbicides. One interaction that was problematic for patients was the use of St. John’s wort for treating depression. St. John’s wort induces cytochrome P450 3A4, which is the enzyme responsible for metabolism of many different drugs, including chemotherapy (Cassileth et al., 2007). Other herbal supplements without value to patients include: ■ Essiac – an herbal compound developed by a native healer and promoted by a Canadian nurse. It contains four herbs: burdock, turkey rhubarb, sorrel, and slippery elm. The NCAAM research group found no benefits for the compound and that an adverse effect was the stimulation of breast cancer cells ■ Kava – although shown to be more effective in treating anxiety, stress, and insomnia, it also had the unwanted effect of fatal hepatotoxicity ■ Dong-quai and licorice – have phytoestrogen activity ■ Iscador – a mistletoe extract. Despite frequent use in Europe, there have been no definitive studies that show positive effect with the use of this botanical (Cassileth & Gubili, 2009; Vickers & Cassileth, 2006) There is one botanical that is commonly used for pain, capsaicin. Topical capsaicin is an over-the-counter drug that comes in two strengths, 0.025% and 0.075%. The amount of the active ingredient in the cream is very small, as the cream can have an intense burning sensation when applied. Capsaicin is the active ingredient in cayenne peppers (Khatta, 2007). It can be made into plasters or applied as a cream over the painful area. The patient needs to use the cream four times a day for 2 weeks to expect any change in the pain (D’Arcy, 2011). Patients should use gloves when applying the cream to avoid any contact with other areas of the body. The use of capsaicin is recommended for neuropathic pain of all types. These types include: ■ Painful diabetic neuropathy ■ Postherpetic neuralgia ■ Fibromyalgia ■ Cluster headaches ■ Postmastectomy pain syndrome ■ Cutaneous pain associated with a skin tumor ■ Postamputation stump pain (Micozzi, 2008)

Vitamins The use of vitamins is controversial. Riboflavin, magnesium, vitamin E, and thiamine are all used for a variety of pain types. For patients with breast cancer, vitamin D deficiency can be associated with bone loss, arthralgias, and falls (Peppone et al., 2011). Research data also suggest that

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112 6. Complementary and Alternative Medicine Techniques for Managing Pain vitamin D deficiency is associated with an increased incidence of breast cancer (Abbas et al., 2008). Dangers with the use of vitamins and supplements include: ■ Metabolic interactions affecting the action of the cytochrome P450 3A4 pathways ■ Antioxidant action, which occurs with ingestion of antioxidants such as grape seed extract ■ Hormonal effects such as those seen with soy products that affect estrogen therapies (Vickers & Cassileth, 2006) Herbal supplements can upregulate unwanted substances such as Pgp-170, which is a multi-drug-resistant transporter in several recognized cancer cell lines. For patients having surgery, garlic and vitamin E can increase the potential for bleeding (Vickers & Cassileth, 2006).

SUMMARY Women seem to like CAM therapies and use them regularly. Herbals and vitamins should never be used without consulting a physician to determine what adverse effects are possible, while other therapies like yoga or exercise can be helpful and are noninvasive. Since so many patients admit that they use these techniques, health care providers should always include a discussion about these techniques in their patient interactions to determine just what types of therapy the patient is interested in using. Combining these techniques into a multimodal plan of care can help the patient better manage pain, increase quality of life, and relieve stress and anxiety.

Case Study Alicia is a 50-year-old patient with chronic abdominal pain. She finds the pain medications very hard to tolerate and hopes there is something she can use for both treatment and symptom control that is not so hard on her body. She comes in to her usual appointment and asks about some complementary therapies she learned about over the Internet. She wants to know about the use of relaxation techniques and herbal supplements. She likes music but has no interest in acupuncture. Her pain is always in the moderate level, 4–6/10 at the old surgical site, and she has recurrent nausea. What kinds of therapies can you suggest and what kind of information does Alicia need to know?

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Questions to Consider 1. As with any addition to the treatment regimen, doing a risk– benefit analysis is a good start. What would you say about Alicia’s requests? 2. What are some positive forms of CAM therapy that you could offer to Alicia? 3. How will you educate Alicia about CAM therapies and how to use them effectively?

REFERENCES Abbas, S., Lineseisen, J., Slanger, T., Kropp, S., Mutschelknauss, E., Flesch-Janys, D., & Chang-Claude, J. (2008). Serum 25-hydroxyvitamin D and risk of post-menopausal breast cancer—results of a large case-control study. Carcinogenesis, 29, 93–99. American Pain Society. (2006). Pain control in the primary care setting. Glenview, IL: Author. Anderson, K., Cohen, M., & Mendoz, T. (2006). Brief cognitive behavioral audiotape interventions for cancer related pain. Cancer, 107, 207–214. Bardia, A., Barton, D., Prokop, L., Bauer, B., & Moynihan, T. (2006). Efficacy of complementary and alternative medicine therapies in reliving cancer pain: A systematic review. Journal of Clinical Oncology, 24(34), 5457–5464. Carlson, L., & Bultz, B. (2008). Mind-body interventions in oncology. Current Treatment Options in Oncology, 9, 127–134. Carroll, J., Gray, R., Orr, V., Chart, P., Fitch, M., & Greenberg, M. (2000). Changing physicians’ attitudes toward self-help groups: An educational intervention. Journal of Cancer Education, 15, 14–18. Cassileth, B., Deng, G., Gomez, G., Johnstone, P., Kumar, N., & Vickers, A. (2007). Complementary therapies and integrative oncology in lung cancer: The ACCP Evidence based Clinical Practice Guidelines. Chest, 132, S340–S345. Cassileth, B., & Gubili, J. (2009). Integrative oncology: Complementary therapies in cancer care. In Cancer and drug discovery development: Supportive care in cancer therapy (pp. 269–277). Totowa, NJ: Humana Press. Christie, W., & Moore, C. (2005). The impact of humor on patients with cancer. Clinical Journal of Oncology Nursing, 9 (2), 211–218. D’Arcy, Y. (2011). Compact clinical guide to chronic pain management. New York, NY: Springer Publishing Company. Dillard, J., & Knapp, S. (2005). Complementary and alternative pain therapy in the emergency department. Emergency Medical Clinics of North America , 23, 529–549. DiStasio, S. (2008). Integrating yoga into cancer care. Clinical Journal of Oncology Nursing, 12 (1), 125–130. Elkins, G., Fisher, W., & Johnson, A. (2010). Mind-body therapies for integrative oncology. Current Treatment Options in Oncology, 11, 128–140.

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114 6. Complementary and Alternative Medicine Techniques for Managing Pain Gratus, C., Wilson, S., Greenfield, S., Damery, S., Warmington, S., Greive, R., … Routledge, P. (2009). The use of herbal medicines by people with cancer: A qualitative study. BMC Complementary and Alternative Medicine, 9 (14), 1–7. Hirsch, A. (2008). Aromatherapy. In M. Weintraub, R. Mamtani, & M. Micozzi (Eds.), Complementary and integrative medicine in pain management. New York, NY: Springer Publishing Company. Khatta, M. (2007). A complementary approach to pain management. Topics in Advanced Practice Nursing e-Journal, 7(1). Retrieved from http://www.medscape.com/ viewarticle/556408 Lu, W., & Rosenthal, D. (2010). Recent advances in acupuncture and safety considerations in practice. Current Treatment Options in Cancer, 11, 141–146. Micozzi, M. (2008). Herbal remedies and miconutrients. In M. Weintraub, R. Mamtani, & M. Micozzi (Eds.), Complementary and integrative medicine in pain management. New York, NY: Springer Publishing Company. Montgomery, G., Weltz, C., & Seltz, M. (2002). Brief presurgery hypnosis reduces distress and pain in excisional biopsy patients. International Journal of Clinical and Experimental Hypnosis, 50, 17–32. Nascimento, S., Surita, F., & Cecatti, J. (2012). Physical exercise during pregnancy: A systematic review. Current Opinions in Obstetrics and Gynecology, 24(6), 387–394. National Center for Complementary and Alternative Medicine. (2004). NCCAM-funded research for 2003. Retrieved from http://nccam.nih.gov/research Paley, C., Bennett, M., & Johnson, M. (2010). Acupuncture for cancer induced bone pain. Evidence-based Complementary and Alternative Medicine, 2011, 671043. Paley, C., Johnson, M., Tsahni, O., & Bagnall, A. (2011). Acupuncture for cancer pain in adults. Cochrane Database of Systematic Reviews, 1, CD007753. Peppone, L., Huston, A., Reid, M., Rosier, R., Zakharia, Y., Trump, D., … Morrow, G. (2011). The effect of various vitamin D supplementation regimens in breast cancer patients. Breast Cancer Research and Treatment, 127, 171–177. Pierce, B. (2009). A non-pharmacologic adjunct for pain management. Nurse Practitioner, 34(2), 10–13. Smith, A. (2005). Opening the dialogue: Herbal supplementation and chemotherapy. Clinical Journal of Oncology Nursing, 9 (4), 447–450. Stoney, C., Wallerstedt, D., Stagl, J., & Mansky, P. (2009). The use of complementary and alternative medicine for pain. In Biobehavioral approaches to pain (pp. 381–408). New York, NY: Springer Science and Business Media. Vickers, A., & Cassileth, B. (2006). Principles of complementary and alternative medicine for cancer. In A. E. Chang, D. F. Hayes, H. I. Pass, R. M. Stone, P. A. Ganz, T. J. Kinsella, & V. J. Strecher (Eds.), Oncology: An evidence-based approach (pp. 194–203). New York, NY: Springer. Ward, L., Stebbings, S., Cherkin, D., & Baxter, G. D. (2013). Yoga for functional ability, pain and psychosocial outcomes in musculoskeletal conditions: A systematic review and meta-analysis. Musculoskeletal Care. doi:10.1002/msc.1042

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Warren, A., Brorson, H., Borud, L., & Slaving, S. (2007). Lymphedema: A comprehensive review. Annals of Plastic Surgery, 59 (4), 464–472. Yates, J., Mustian, K., Morrow, G., Gilles, L., Padmanabhan, D., … Colman, L. (2005). Prevalence of complementary and alternative medicine use in cancer patients during treatment. Supportive Care in Cancer, 13, 806–811.

ADDITIONAL RESOURCES Alimi, D., Rubino, C., Pichard-Leandri, E., Fermand-Brulee, S., Dubreuil-Lemarie, M., & Hill, C. (2003). Analgesic effect of auricular acupuncture for cancer patients: A randomized blinded controlled trial. Journal of Clinical Oncology, 21, 4120–4126. Cohen, L., Warnecke, C., Fouladi, R., Rodriguez, M., & Choul-Reich, A. (2004). A psychological adjustment and sleep quality in a randomized trial of the effects of a Tibetan yoga intervention in patients with lymphoma. Cancer, 100(10), 2253–2260. Crew, K., Capodice, J., Greenlee, H., Brafman, L., Fuentes, D., Awad, D., . . . Hershman, D. L. (2010). Randomized, blinded, sham-controlled trial of acupuncture for the management of aromatase inhibitor-associated joint symptoms in women with early stage breast cancer. Journal of Clinical Oncology, 28(7), 1154–1160. Galantino, M. I., Desai, K., Greene, L., De Michele, A., Stricker, C. T., & Mao, J. J. (2012). Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgia. Integrative Cancer Therapies, 11(4), 313–320. Hollis, A. (2010). Acupuncture as a treatment modality for the management of cancer pain: The state of the science. Oncology Nursing Forum, 37(5), E344–E348. Huang, S. T., Good, M., & Zauszniewski, J. A. (2010). The effectiveness of music in relieving pain in cancer patients: A randomized controlled trial. International Journal of Nursing Studies, 47, 11354–1362. Ulger, O., & Yagh, N. (2010). Effects of yoga on the quality of life in cancer patients. Complementary Therapies in Clinical Practice, 16, 60–63.

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7 Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia

Acute pain is defined as pain that is brief, and that resolves within hours, days, or several weeks. It is usually the result of injury, surgery, or trauma. Acute pain serves a protective function and lets the patient know that she has been injured. One of the most negative outcomes of an acute pain experience is the patient’s potential to develop a chronic pain condition that is more difficult to treat, such as complex regional pain syndrome. For patients with trauma, 15% will report severe persistent pain following surgery, 5% to 60% of patients will report residual pain, while the patients reporting severe disabling pain will range from 4% to 10% (Lavand’homme, 2011). The focus of treating acute pain should then be to reduce the pain to a tolerable level while facilitating a return to the highest possible level of functionality. Although both men and women experience acute pain, there are differences related to medication response rather than to a particular modality, for example, patient-controlled analgesia (PCA). As described earlier, morphine is more effective in men, while in women, kappa agonist pain medications are effective and opioids have a slower onset of action. There are two common methods of acute pain management in hospitals besides medication management, PCA and epidural pain management. Though PCA is commonly used for pain, epidural analgesia is also an option for patients with more complex surgical pain management needs. There is one study that illustrates some sex-related differences when epidural pain management is used. In a study with 14,988 patients, of which 6,506 were women, pain scores between men and women in the study were relatively equal. However, medication consumption by women was lower than the men, and the women experienced a higher incidence of motor blockade from the local anesthetic component with the epidurals. Of those women who had side effects with the epidural analgesia, body mass index was contributory and vomiting a significant side effect (Schnabel, Poepping, Gerss, Zahn, & Pogatski-Zahn, 2012). 117

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118 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Epidural analgesia is also commonly used for the pain of labor and delivery, so many women have experience with the technique. This chapter will provide some general information on PCA and epidural concepts while the chapter on labor and delivery will provide more in-depth information about epidural use in that setting.

PATIENTCONTROLLED ANALGESIA PCA is more than the machine used to deliver the medication; it is a process. This process consists of the patient, the delivery system, and the medications with pre-set dosing parameters. If any one of these elements is eliminated, the process should no longer be considered PCA. The PCA system consists of a computerized pump that delivers opioid medication through IV tubing into the patient’s intravenous access. The patient is able to activate the machine using a push-button device when pain increases. Once the button is pushed the pump delivers a preset dose of medication to the patient. The pump is programmed by the nurse according to PCA orders written by a licensed prescriber. The pump can be set to deliver several different types of prefilled opioid syringes or bags and it can be programmed to deliver a continuous or basal dose, along with a patient-activated bolus dose. Most patients prefer PCA to other forms of postoperative analgesia because they have some control over their pain relief. They can use the medication when they feel pain and not have to wait for the nurse to answer a call light, get the medication from a medication dispensing machine (PYXIS), and then return to the patient’s room to deliver the medication. The ease of PCA and quick response time for medication delivery are very attractive for patients. A Cochrane review of 55 studies with 2,023 patients reported that PCA provided better pain relief and increased patient satisfaction compared to as-needed (PRN) medication dosing. However, the patients also had a higher medication use and increased pruritis compared to patients using standard means of postoperative pain management (Hudcova, 2006). The first PCAs were developed in the 1970s in an effort to improve upon the current forms of postoperative pain control, which were intramuscular injections and intermittent injections of opioids provided by a nurse. The older forms of medication administration allowed for a period of oversedation then a period of pain relief, followed by a period of pain or end-of-dose failure as the medication dissipated. Because of the potential for irregular medication absorption, IM injections are no longer recommended for pain management (APS, 2008). Blood levels of medication fluctuate and exceed the patient’s needs, and then as blood levels decrease the patient experiences pain. Very often, as pain returns, patients will be told, “It is not

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time for your medication,” and the patient will be forced to wait in pain until the stipulated time is reached. Studies conducted on PCA early in the 1970s indicated that small doses of medication given at regular intervals provided superior pain relief to the standard IM injections and eliminated the variation in pain relief with intermittent injections (Grass, 2005). Each patient has an individual blood level of medication that will provide pain relief. With PCA, the patient should be medicated with loading doses until an acceptable level of pain relief is achieved, allowing the patient to maintain pain control with patient activated bolus doses. With PCA machines, no matter how often a patient pushes the button, he will receive only the dose that is programmed into the pump in the preset lockout time. If the patient starts to become sedated he will stop pushing the button. If the patient falls asleep he will usually wake and use the button as pain returns.

SMART PUMP TECHNOLOGY FOR PCA AND EPIDURAL PUMPS One of the newest advances in PCA technology is the development of smart pumps that can be preprogrammed with drug libraries and dosing limits to help ensure that patients receive only what the pump will allow. The use of this system is aimed at increasing patient safety by decreasing the number of programming and human errors that occur with PCA. Drug libraries are developed by each institution. One element that was never previously identified is the determination of the patient’s opioid status. The drug library in a smart pump can be programmed to allow dosing for both opioid-naïve and opioid-tolerant patients. This differentiation of patient opioid use should eliminate dosing errors that put opioid-naïve patients at risk. Clinical Pearl

O pioid-naïve pa ent: Pa ent who has not been taking opioids regularly prior to star ng therapy on a PCA. O pioid-tolerant pa ent: Pa ent who has been taking opioids for at least 1 week prior to star ng PCA therapy. To be considered opioid tolerant the pa ent should be taking the equivalent of 60 mg of oral morphine, 30 mg of oral oxymorphone, or 8 mg of oral hydromorphone daily (D’Arcy, 2011).

In this way patients who are opioid tolerant and require higher doses will be dosed using a separate drug library with higher dose limits, while patients who are not opioid tolerant are protected from the inadvertent use of high-dose opioids.

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120 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia In addition to the use of drug libraries, the smart pump can download information and produce reports. The Institute for Safe Medication Practice (ISMP) recommends that hospitals set up policies that govern how the data are retrieved from smart pumps (Kirkbride & Vermace, 2011).

PCA MEDICATIONS AND ORDERS There are several medications and medication combinations that can be used in PCA pumps (Exhibit 7.1). The most common opioids are morphine, hydromorphone (Dilaudid), and fentanyl (Sublimaze). Other medications such as methadone (Dolophine) and buprenorphine (Buprenex) can also be used but have more specific actions, such as extended half-life for methadone and mixed agonist–antagonist activity for buprenorphine. These medications are used for specific indications, such as methadone for cancer pain. Women may benefit from the availability of PCA buprenorphine. Each medication has a benefit that can be used to maximize pain relief for a patient. Each patient also has a genetic uniqueness that makes some types of medication work most effectively. Pairing the right medication with the patient’s genetic predisposition and metabolic characteristics can provide the best pain relief possible. Looking at how effective pain relief is with a specific medication can indicate that the patient’s genetic make-up accepts the medication effectively for pain relief, without having to genetically profile the patient.

Exhibit 7.1 PCA Dosing Medication Doses for Use in PCAs Medications

Loading Dose

Bolus Dose

Lockout

Morphine

2 mg

1–2 mg

6–10 min

Hydromorphone

0.5 mg

0.2–0.4 mg

6–10 min

Fentanyl

25 mcg

10–20 mcg

5–10 min

Buprenorphine

 

0.03–0.1 mg

8–20 min

Methadone

 

0.5 mg

8–20 min

Meperidine: Not recommended for use Basal infusions not recommended for opioid-naïve patients. Sources: Grass, 2005; Hurley, Cohen, & Wu, 2010.

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PCA Medications and Orders

Clinical Pearl

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T he binding ability and ac vity of a medica on being used for PCA is in part related to its chemical structure. For example, morphine is hydrophilic (water loving) and tends to spread throughout the body in the aqueous regions. Since the spread is so wide, it tends to remain ac ve for longer periods of  me. Fentanyl, on the other hand, is lipophylic (fat loving), crosses the blood–brain barrier easily, and tends to move in and out of the body more quickly, making it necessary for repeated doses in short periods of  me to maintain pain relief.

Medication choice and dosing for PCA is extremely important and individual. The patient must receive enough loading medication either through intermittent injection of doses through the PCA or through the IV so that the patient reaches a comfort level that can be maintained by bolus doses. Medications that can be used in PCA pumps include: Morphine – considered the gold standard for IV PCA and equianalgesic conversions. Excreted by glucuronidation, it has a metabolite called morphine-6-glucuronide that is renally excreted, creating the potential for accumulation and delayed excretion. This increases the potential for increasing and delaying sedation in patients with renal impairment. Hydrophilic activity with maximum serum levels is reached within 6 minutes and steady state within 16 to 20 hours (Thomas & von Gunten, 2006). Hydromorphone – considered to be six times more potent than morphine (Grass, 2005). It is metabolized in the liver and excreted as an inactive glucuronide metabolite, which is a benefit for patients with renal impairment. Small doses can provide a high level of pain relief, thus decreasing the potential for adverse effects such as nausea or pruritis. Its hydrophilic action is similar to morphine. Hydromorphone is more midrange than morphine and reaches peak effect in 30 to 60 minutes (Fine & Portneoy, 2007). Fentanyl – considered 80 to 100 times more potent than morphine with single doses, and with repeated dosing 33 to 40 times the potency of morphine (Grass, 2005). Metabolized in the liver and not excreted renally, it is a suitable medication for patients with renal failure. Its lipophilicity provides high bioavailability, so it can easily penetrate the blood–brain barrier but also have a rapid offset (Thomas & von Gunten, 2006). Peak effect is reached in less than 10 minutes (Fine & Portnoy, 2007). Methadone – lipophilic action with mu receptor agonism, coupled with NMDA receptor antagonist activity (Hurley, Cohen, & Wu, 2010).

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122 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Prescribing should be reserved for pain specialists or those familiar with methadone prescribing, and use should be confined to special patient populations such as oncology. The half-life of methadone is 8 to 72 hours, with 1 to 15 days required to reach a steady state (Thomas & von Gunten, 2006). This time delay creates a significant potential for delayed respiratory depression (APS, 2008). Because of the extended half-life, it may be considered a good choice for highly opioid-tolerant oncology patients. Peak effect with methadone is variable but is generally considered to be within 1 to 2 hours (Fine & Portnoy, 2007). Extreme caution should be used in opioid-naïve patients. There is also potential for cardiac arrhythmias with long-term use. High-dose patients will need an electrocardiagram (ECG) as a baseline at medication initiation with monitoring ECG every 6 months for any Q-T interval changes (APS, 2008). Buprenorphine – mixed agonist–antagonist activity. Mu opioid receptor partial agonist coupled with kappa opioid receptor antagonist (Hurley et al., 2010). Not a first-line option for pain relief, but it has been used successfully for gynecological surgeries. Buprenorphine may provoke an acute withdrawal syndrome when a pure opioid agonist has been used for pain control before the mixed agonist–antagonist. High potential for psychotomimetic side effects such as hallucinations (Grass, 2005) Ketamine – NMDA receptor antagonist that blocks activation of NMDA receptor sites activated with continued pain stimuli. Combined with opioids in PCA, low-dose ketamine has been shown to reduce opioid consumption (Subramian et al., 2004). A new Cochrane review has shown that ketamine with PCA reduced 24-hour PCA consumption and reduced post operative nausea and vomiting (PONV) (Bell, Dahl, Moore, & Kalso, 2010). Additionally, ketamine has a high profile for side effects such as hallucinations, memory problems, abuse, and addiction (APS, 2008). Given the results of the current studies, future research with ketamine use would need to have more consistent positive results to make a clinical recommendation. One medication that has fallen out of favor for use in general pain management as well as PCAs is meperidine. For many years it was a mainstay for pain relief in postoperative patients. Now pain management societies have moved the medication from a first-line pain medication to a second-line option and discourage its use altogether. Meperidine has the potential for seizures associated with a toxic metabolite called normeperidine that can accumulate in central nervous system (CNS) fluid. For these reasons, it is not recommended for use with patients who have a renal impairment or CNS disease. It should not be used long term and, if used at all, the cumulative daily dose should be no higher than 600 mg/24 hours,

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and it should be used for the shortest period of time possible. The best choice is to eliminate its use and select one of the other medications, such as morphine or hydromorphone, for PCA use. The Joint Commission recommends that all hospitals have standard or pre-printed orders that can be used by any practitioners licensed to prescribe opioids. Listed on the order set should be the drug, concentration, loading dose, bolus or demand dose, PCA lockout, and 1- or 4-hour totals. The Joint Commission also recommends the use of standardized concentrations so that fewer medication errors are made when unusual or nonstandard concentrations are ordered. Included on the order set should be a monitoring protocol for frequency of vital signs, oxygen saturation, and respiratory status. Some order sets include an order for naloxone (Narcan), an opioid reversal agent that is used to reverse oversedation in patients. An additional section listing treatments for adverse effects such as nausea/ vomiting, pruritis, and urinary retentions should be included. Setting up a PCA requires knowledge of the patient’s opioid use prior to the surgery, any prior difficulties with particular opioids, and knowledge of what medications are commonly used for PCA. The use of a basal rate on PCAs where medication is delivering continuously is not recommended for opioid-naïve patients (APS, 2008; Grass, 2005; Hurley et al., 2010; ISMP, 2009). It has been found to have little additive effect for pain relief but it is considered to be a high-risk factor for increasing sedation (APS, 2008; ISMP, 2009). The use of basal infusions on PCAs is more appropriate, in fact a necessity, when highly opioid-tolerant patients are not taking oral medications and need to have their usual daily oral medication dose changed to PCA delivery postoperatively. To order a PCA for a patient, first select the opioid with a standard concentration; select the doses and lockout; add any additional order for antiemetics, laxatives, and so on; and dose. For example, a PCA prescription might read: Drug: Morphine 1 mg per mL Mode: PCA only; no basal rate selected Loading dose: 2 mg Dose: 1 mg Lockout: 6 min 1-hour total: 10 mg Clinician bolus: 2 mg every 4 hr as needed for increased pain or activity; no more than 4 doses in a 24-hr time period Monitoring parameters, respiratory rate, oxygenation, vital signs, etc. Laxatives, antiemetics An example of a standardized order sheet is provided in Exhibit 7.2.

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124 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Exhibit 7.2 PCA Physician’s Orders

Other important elements of PCA ordering to consider are: The loading doses for morphine should be patient dependent and range between 2 and 4 mg (Grass, 2005). An equianalgesic conversion can be used to order loading doses with other medications, for example, hydromorphone (0.4 mg to 0.8 mg).

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The 1- or 4-hour total is controversial at this time. There are differing opinions as to the necessity of the parameter or whether a 1- or 4-hour total is more effective. The advantage to using a 1-hour total, which should equal the total number of doses available to the patient in the hour, is that you can quickly determine if there is a need for adjusting PCA doses. By waiting 4 hours the patients may be under- or overdosed for a longer period of time. Using clinician or supplemental boluses allows the nurse to give an extra dose of medication when the patient needs it. For example, if a patient falls asleep and does not push the button and wakes in pain, the nurse can administer the extra dose after assessing that the patient is stable enough to tolerate the additional medication. These doses are also helpful for providing the patients with additional medication for activity, such as physical therapy or walking around the unit. Monitoring parameters help to ensure that the patient is being carefully watched while using PCA. If supplemental oxygen is being used, electronic monitoring with pulse oximetry may be skewed with blood oxygen levels in the 70s, while oximetery readings may be much higher (Vila et al., 2005). Having the nurse assess the patient every 2 to 4 hours can provide a trained eye on the patient’s real status. Additionally, capnography has been found to provide a more accurate reading on blood oxygen levels in postoperative patients and is being used more frequently in the postoperative setting to detect increasing carbon dioxide (CO2) levels that could lead to oversedation. Some PCA pumps have an inline capnography system that can monitor CO2 levels while the PCA is being used.

MONITORING PCA AND TREATING ADVERSE EFFECTS

Sedation/Oversedation Respiratory depression, sedation, and oversedation can occur with any patient. Although these events are thought to occur frequently, the actual level of occurrence is thought to be 0.25% (Grass, 2005), 0.19% to 5.2% (Hagle, Lehr Brubakkken, & Shippee, 2004), or ,5% (Hurley et al., 2010). Compared to the incidence of respiratory depression (0.9% for intermittent IM injections), PCA compares favorably (Grass, 2005). Monitoring parameters are set by order on the PCA form. Using a simple numeric sedation scale—the Ramsey on general nursing units or the RASS in critical settings—may find early stages of sedation and avoid progression to oversedation. Conditions contributing to respiratory depression with PCA use include concomitant administration of other sedating agents

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126 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia such as sleeping medications; the use of a basal rate in advanced age or opioid naive patient; and pulmonary conditions such as sleep apnea (Hurley et al., 2010). Additionally, Hagle et al. (2004) report that risk factors for sedation with PCA include: age .70 years; basal infusion with IV PCA; renal, hepatic, pulmonary, or cardiac impairment; sleep apnea; concurrent CNS depressants; obesity; upper abdominal or thoracic surgery; and an IV PCA bolus dose .1 mg. If the patient becomes oversedated, the use of naloxone (Narcan) is recommended to reverse the effects of the opioid and restore normal respiratory status. If Narcan is administered, an alternate form of pain management will be needed in the immediate postadministration time period. For patients with sleep apnea, the ASA and The Joint Commission recommend more aggressive monitoring when opioids are used in the postoperative setting.

Postoperative Nausea/Vomiting (PONV) All opioid medications have the potential to create nausea and vomiting. A Consensus Guideline by the American Society of Postanesthesia Nurses (ASPAN) (2006) indicates that some patients are at a higher risk of developing PONV, including: females, those with a history of motion sickness or PONV, nonsmokers, and those administered postoperative opioids. The use of antiemetics such as ondansetron is needed for these patients to control PONV. For many patients the use of antiemetics starts in the operating room in an effort to control PONV.

Constipation As with PONV, constipation is a natural outcome of regular opioid use. For all patients using opioids for postoperative pain control, laxatives and stool softeners are recommended to maintain adequate bowel function. Constipation is the only adverse effect where patients cannot become tolerant. The use of stool softeners such as Colace and laxatives such as Senokot, Miralax, or milk of magnesia can restore normal bowel function despite opioid use.

Pruritis All opioids can cause pruritis, and some patients are more prone to pruritis with opioids. The occurrence of pruritis does not mean that the patient has an allergy to the medications. The generalized itching felt by the patient with opioid use is thought to be the result of histamine release

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or another unknown physiologic mechanism. It follows, therefore, that the use of an antihistamine such as diphenhydramine (Benadryl) is recommended. Unfortunately, if diphenhydramine is used it can add to patients’ cumulative sedation potential and lower doses are considered appropriate, especially if used for the elderly. One medication used to reduce pruritis is nalbuphine (Nubain) at a dose one fourth to one half of the standard dose, 2.5 to 5 mg IV, but the health care professional should be aware that this is an off-label medication use.

Delirium, Confusion Confusion and delirium may occur in older patients taken out of familiar surroundings and receiving medications for pain and surgery. Some practitioners confuse delirium, a sudden onset of an acute confusional state, with the progressive decline in cognitive function seen in patients with dementia. Although most often considered a condition that affects the older patient, delirium can happen to any patient who receives opioids, surgical medications, or undergoes a form of sedation. The incidence of delirium in the general hospital population is felt to range from 10% to 60% of all patients (Wang, Mullen, & Leung, 2006). Patients who are taking oral pain medications have less delirium, while for those patients who are older and those who receive IV pain medications the rate is higher (Wang et al., 2006). It is also important to note that unrelieved pain can contribute to delirium. If a patient on PCA becomes confused, changing medication to the oral route (if possible) may help, but adding other nonopioid interventions such as nonsteroidal anti-inflammatory drugs, blocks, and neural blockades may be helpful while eliminating other contributing medications such as benzodiazepines and other medications with CNS effects.

RECOMMENDATIONS FOR SAFE PCA USE The Joint Commission and ISMP have tracked PCA use for many years. They have found that there are significant safety issues with PCA and have issued some recommendations to make the practice safer for all—prescribers and patients. One of the issues that have emerged from safety-monitoring systems includes cases of overdose and death with PCA, with PCA found to play a role in each case (ISMP, 2003; JCAHO, 2005). Current estimates of risk with PCA indicate that death from user programming errors was estimated to be 1 in 33,000 to 1 in 338,800 resulting in an estimate of 65–667 deaths in the history of use of the device (Vicente, Kada-Beklaed, & Hillel, 2003). Other concerns are linked to operator error and misprogramming. In one

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128 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia quality improvement study 71% of the errors found were related to misprogramming, causing either overmedication or undermedication; 15% were related to human factors, resulting in administration of the wrong medication; and 9% were related to equipment problems (Weir, 2005). The most common programming errors were found to be: ■ Confusion over milliliter and milligram ■ Confusing the PCA bolus dose with the basal dose ■ Entering the loading dose instead of the bolus dose ■ Wrong lockout setting selected ■ Wrong medication concentration selected (ISMP, 2003) Because of the errors that were found in the monitoring systems, The Joint Commission and ISMP have made recommendations about PCA that can help to ensure the safest possible PCA practice. The current recommendations include two independent nurse checks of medication, concentration, and dose settings, clear identification of the IV line where the PCA is infusing, use of prefilled syringes or bags, and use of standardized order sets. The Joint Commission has also addressed some pertinent practice issues and has made recommendations for practice in these areas.

Proper Patient Selection Choosing the correct patient type and limiting PCA use to those patients who are good candidates can ensure that PCA is properly used. PCA is a fairly simple concept to understand and children as young as 5 years of age have demonstrated that they can safely activate a PCA pump. The Joint Commission and ISMP have listed several patient groups that they feel are not good candidates for PCA use, including infants and young children; confused older adults; patients who are obese or have sleep apnea or asthma; and patients taking other medications with sedating effects such as muscle relaxants, antiemetics, and sleeping medications (Cohen & Smetzer, 2005).

PCA by Proxy The term PCA by proxy is usually defined as the activation of the PCA pump by someone other than the patient. This is usually a friend or family member who perceives the patient to be in pain but unable to activate the pump independently. Most hospitals have a policy that prevents anyone but the patient from activating the PCA, including nurses or other staff members. Once the patient is removed from the PCA process, the potential for potentially fatal oversedation is very real. Of the 460 PCA errors reported to Pharmacopeia, the PCA errors database of the United States, 12 were related to PCA by proxy, with one fatal event.

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PCA Pump Safety Since the PCA pump is an integral piece of the PCA process, safe pump design can help to minimize the occurrence of adverse events, medication errors, and misprogramming. PCA pump buttons should not resemble call lights so that the patient can discriminate which button brings the nurse and which one delivers pain medication. Intuitive programming features can make it easier for nurses to enter prescriptions and monitor medication usage. Free-flow protection should be a part of every pump that is designed for use as a PCA. The new smart pump technology is being widely implemented to help decrease operator error and improve patient safety with PCA use.

Human Errors Human errors are always possible when interacting with machines, but designing pumps that are simple and easy to use while protecting the patient can help to decrease error. Nurses are also responsible for learning to correctly enter PCA orders and maintaining competency in PCA practice. Using root cause analysis after PCA-related incidents can help pinpoint areas in the PCA process that need correction so that future errors can be avoided.

PATIENTS NEEDING SPECIAL CONSIDERATION WITH PCA USE Although The Joint Commission has set recommendations for patient selection with PCA use, there are other patient populations that require special consideration. Cognitively intact older patients, patients with a history of substance abuse, and patients who use opioids for relief of chronic pain require special consideration when PCA is being considered as a means of pain control. Other factors such as weight play no role in PCA dosing, although men have been found to require more morphine than women (Burns, Hodsman, & McClintock, 1989).

Older Patients Patients who are older than 65 years of age require special considerations when PCAs are being used for pain management. Despite the older age they can be excellent candidates for PCA use, especially during large orthopedic procedures such as total joint replacements. The majority of these patients are opioid naïve and have some level of organ dysfunction related

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130 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia to age. For these patients, opioids can be prescribed, but the doses should be reduced by 25% to 50% and monitoring should be more frequent. In a study comparing morphine consumption in younger versus older patients, for patients 20 to 30 years of age morphine consumption was 75 mg, while for those patients 60 to 70 years of age the morphine consumption was 30 mg (Macintyre & Jarvis, 1996). Older age seems to be an indicator that less pain medication may be needed to control pain.

Patients With Chronic Pain Patients who have chronic pain or are taking regular opioids for pain relief are another group difficult to treat. These patients have increased pain-processing pathophysiology that may make their pain more intense, increase sensitivity to pain, and reduce effectiveness of opioids. These patients will require their normal daily doses of opioids to be restarted as soon as possible and continued through their hospitalization. They will also need additional medication for the new acute pain above and beyond their usual daily opioid requirements. If the usual oral medications cannot be restarted in a timely fashion, the conversion to IV or PCA will need to be made but the efficacy of these doses may also be reduced. For these patients a continuous infusion using an equianalgesic conversion and allowing for the PCA demand dose medication will have to be performed. Many pharmacists are skilled at these conversions and are willing to help the describer with conversion doses.

Patients With a Substance Abuse History For patients with a history of substance abuse or active drug use, treating pain either from acute injury or surgery is a challenge. Since there is no equianalgesic conversion or quality control for street drugs, a best-guess estimate will be needed and a full history of how much drug is being used daily is essential. The actively addicted patients will need a continuous infusion with generous bolus doses to account for any underdosing and avoid withdrawal. The patient with a history of substance abuse is someone who has used drugs in the past but, and although no longer using them, is still having pathophysiologic changes that make treating the pain more difficult. These patients also have an increased sensitivity to pain stimulus and a decreased efficacy of opioid medications. For these patients, a continuous rate may be needed and the doses will need to be higher than the surgery or acute pain might indicate. Although these patients are highly opioid tolerant, it is still possible to have them become oversedated if the doses are large enough, so it is important to maintain the frequent monitoring parameters.

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For all of these patients PCA is a good option, although there are adjustments that will need to be made. It is important to set up reasonable expectations about medication use and pain relief. Postoperative patients cannot expect to be pain free, and although some patients have chronic pain the focus in the postoperative setting is on the surgical pain. Adequate postoperative pain management should facilitate activity, restore functional status, and provide for a timely discharge. Clinical Pearl

I n order to use the 0 to 10 NPS for diffi cult-to-treat pa ents, ask the pa ent with chronic pain to score his or her average daily pain, and set a realis c pain goal of 2 or 3 points lower for the new acute pain. For older pa ents, set an achievable pain goal and ask the pa ent what pain ra ng would be reasonable for her to par cipate in ac vity and physical therapy. For addicted pa ents or pa ents with a history of substance abuse, set parameters around medica on use and set a reasonable goal for pain relief. Explain that no pain or 0/10 pain is not reasonable for the type of surgery/injury the pa ent has sustained. Also indicate that purposeful seda on is not the goal of PCA therapy; pain relief is the focus and goal.

EPIDURAL BASICS Epidural pain management can provide the largest amount of pain relief with the least amount of medication. In most cases, an epidural is placed perioperatively and either used during surgery as an alternate to general anesthesia or used not only during surgery but as postoperative analgesia. The medication used for epidural pain management binds to opioid receptors in the dorsal horn of the spinal cord and can produce effective analgesia at greatly reduced doses. In most cases, epidurals used for postoperative pain relief have solutions that contain both low-dose opioids and local anesthetics. Some patients are resistant to epidural catheters, fearing that they will have a needle in their back during the time of the infusion. Patients should be reassured that the needle is only used for placing the catheter and that the catheter tubing itself is very small and soft. Patients who are good candidates for epidural analgesia are patients with major surgeries, such as: ■ Thoracotomy ■ Large abdominal surgeries ■ Aortic aneurysm repair ■ Orthopedic patients (total joint replacements) ■ Labor and delivery patients (used for delivery)

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132 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia To place an epidural catheter the patient is placed into a sitting or side-lying position with the back flexed in an outward curve. The anesthesiologist or certified nurse anesthetist inserts a hollow needle through the skin and into the epidural space, which is really a potential space between the ligament flavum and the dura mater (Figure 7.1). It does not extend into the cerebral spinal fluid (CSF) or the spinal cord. Once the anesthesiologist or certified nurse anesthetist feels a loss of resistance, he or she is fairly certain of having entered the epidural space. Once the catheter is determined to have proper placement, the practitioner can then bolus the catheter to determine the effect. The epidural space contains a variety of structures that include spinal nerve roots, fat, areolar tissue, lymph tissue, and blood vessels, including a rich venous plexus (Rockford & DeDeruyter, 2009). Since the analgesic effect is so localized, the catheter is placed at the level of the expected surgical incision, with catheter placement being done most commonly in the thoracic and lumbar spinal levels. The medication “spread” is determined by the site of injection. Additional factors that may influence medication spread are the patient’s age and the volume of drug being infused (Rockford & DeRuyter, 2009). It is important to note the once the epidural catheter reaches the epidural space it can migrate upward (rostral) or downward (caudal). Th is migration can affect the way the patient feels the analgesic eff ect. In some cases the epidural catheter may be providing analgesia to a

Epidural needle

Epidural space Spinal cord

Figure 7.1 ■ The epidural space.

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nonoperative lower extremity, when the intent was to provide analgesic to the operative extremity. Th is effect is caused by the curling of the catheter around the epidural space, leading to a reduced eff ect in the desired location.

Spinal or Intrathecal Differences

Intrathecal space

Spinal Cord

The word “spinal” can be used for either epidural or intrathecal analgesia. However, although the term spinal is closely associated with intrathecal placement, it is more precise to use the terms epidural and intrathecal. For some patients a single dose of preservative-free morphine may be used as an adjunct for postoperative analgesia. These doses are commonly referred to as “single shots.” They are given one time only and an extended-release morphine such as Astromorph or Duramorph is used to extend the action of the medication for 24 hours. When an intrathecal catheter is placed, the catheter extends directly into the thecal space and the medications flow into the CSF fluid (Figure 7. 2).

Figure 7.2 ■ The intrathecal space.

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134 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Either opioids or local anesthetics can be used intrathecally, but continuous infusion of local anesthetics are associated in some cases with the development of cauda equina syndrome (Scientific evidence, 2005). A combined spinal (intrathecal)-epidural technique can provide a faster onset of analgesia and increased maternal satisfaction with pain relief during labor (Hughes, Simmons, & Brown, 2003) Since medications that are inserted into the epidural space need to cross the dura, onset of action with epidural analgesia is slower when compared to intrathecal administration. Since medications infused into the intrathecal space spread through the CSF, a hydrophilic medication such as morphine is more useful. Uptake can take place locally at the site of the insertion through spinal blood vessels, fatty tissue, and CSF, and doses lower than those used epidurally may produce effective analgesia.

EPIDURAL MEDICATIONS All medications that are used for epidural analgesia should be preservativefree since many preservatives such as alcohol-based preparations can damage neural tissue. Most epidural catheter solutions are a combination of a local anesthetic such as bupivacaine or ropivacaine and an opioid, most commonly fentanyl, morphine, or dilaudid. The two drugs that are recommended for use in epidurals are morphine and fentanyl, with dilaudid having less evidence for efficacy (ASA, 2004).

MONITORING PATIENTS ON EPIDURAL ANALGESIA The monitoring of patients on epidurals is similar to PCAs, but more frequent assessment of any numbness related to the local anesthetic is needed. The side effects of epidural opioids are similar to PCA and the treatment options are the same except for pruritis, which occurs more frequently with epidural opioids. Hypotension can also occur with the use of local anesthetics.

SAFETY ISSUES WITH EPIDURAL INFUSIONS One of the most dangerous and significant side effects with epidural analgesia is epidural hematoma. An epidural hematoma is created by bleeding

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Summary

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into the epidural space, usually cause by tissue damage when the catheter is place or removed. If the patient is anticoagulated, the potential for epidural hematoma formation is increased. Although infrequent, the seriousness of the hematoma formation cannot be minimized. Since the bleeding is taking place in a limited and confined area, the expansion of the bleed into the spinal cord can create a clot, leading to spinal cord compression. The cord compression can lead to spinal cord injury and permanent paralysis if not detected in the early stages. Patients with epidural hematomas complain of extremely severe back pain and may progress to loss of lower extremity function and loss of bowel and bladder control. Any patient with an epidural catheter who complains of extreme pain and is on anticoagulants should immediately be screened for epidural hematoma formation by CT or MRI. Because of the significant consequences of an epidural hematoma, the American Society of Regional Anesthesiologists (ASRA, 2002) has drafted a position paper with criteria for use of anticoagulants with epidural patients. These recommendations include: ■ Subcutaneous heparin, no contraindication for placement or catheter removal. ■ Warfarin international normalized ratio, INR required to be ,1.5 for catheter removal and no placement with elevated INR. ■ Low molecular weight heparins, thrombophylaxis, placement 10 to 12 hours after last dose; catheter removal either directly before daily dose or 10 to 12 hours after last dose; medication can be resumed 2 hours after catheter removal.

Antiplatelet Medications ■ ■ ■

Ticlopidine – catheter placement after discontinuation of medication for 14 days Clopidogrel – catheter placement after discontinuation of medication for 7 days Fondaparinux – avoid using indwelling catheters (ASRA, 2002)

SUMMARY Epidurals are used in a wide variety of surgical procedures for women. Aside from use in labor and delivery, gynecological procedures and abdominal surgeries of all types are candidates for use of epidurals to both minimize pain and shorten recovery periods.

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136 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Case Study Denise is a 45-year-old patient who had been having recurrent bleeding between periods and heavy flow during her menses. She was not a candidate for a vaginal hysterectomy, but needed to have an abdominal hysterectomy. When she asked her anesthesiologist about pain control options he recommended an epidural or PCA. She opted for the epidural and was able to control her pain after surgery and went home within just a few days. When her friends asked her why she had asked for the epidural, Denise replied that she never even knew she had surgery, and that she felt so well that pain was not a problem after her surgery. It was more than worth the time it took to place the catheter, she told her friends.

Questions to Consider 1. Did the use of the epidural provide Denise with the best pain relief possible? Judging by her outcomes, should more focus be put on using techniques such as epidural or PCA for postoperative pain relief in women? 2. What are the benefits of using epidural pain management? 3. Do you think Denise would have done just as well with a PCA for pain relief?

REFERENCES American Pain Society. (2008). Principles of analgesic use in the treatment of acute pain and cancer pain. Glenview, IL: Author. American Society of Anesthesiologists. (2004). Practice guidelines for acute pain management in the perioperative setting. Anesthesiology, 100 (6), 1573–1581. American Society for Perianaesthesia Nurses. (2006). ASPAN’s evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. Journal of Perianesthesia Nursing and Health Care, 21(4), 230–250. Bell, R., Dahl, J., Moore, A., & Kalso, E. (2010). Perioperative ketamine for acute postoperative pain. Cochrane Database of Systematic Reviews 2006, Issue 1, art. No. CDoo4603. published 2010. Burns, J. T., Hodsman, N. B. A., & McClintock, T. T. C. (1989). The influence of patient characteristics on the requirements for postoperative analgesia. Anesthesia , 44, 2–6.

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References

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Cohen, M., & Smetzer, J. (2005). Patient-controlled analgesia safety issues. Journal of Pain and Palliative Care Pharmacotherapy, 19 (1), 45–50. D’Arcy, Y. (2007, May/June). Manage pain across the perioperative spectrum. OR Nurse, 38–42. D’Arcy, Y. (2008, January). Keep your patient safe during PCA. Nursing 2008, 50–55. Fine, P., & Portnoy, R. (2007). A clinical guide to opioid analgesia. New York, NY: Vendome Group. Gan, T. J., Meyer, T., & Apfel, C. C. (2003). Consensus guidelines for managing postoperative nausea and vomiting. Anesthesia & Analgesia , 97, 62–71. Grass, J. (2005). Patient controlled analgesia. Anesthesia & Analgesia , 101, S44–S61. Hagle, M., Lhr, V., Brubakken, K., & Shippe, A. (2004). Respiratory depression in adults patients with intravenous patient-controlled analgesia. Orthopedic Nursing, 23 (1), 18–27. Hudcova, J., McNichol, E., Quah, C., Lau, J, & Carr, D. B. (2006). Patient controlled analgesia versus conventional opioid analgesia for postoperative pain. Cochrane Database of Systematic Reviews, (4), CD003348. Hughes, D., Simmons, S. W., & Brown, J. (2003). Combine spinal-epidural versus epidural analgesia in labour. Cochrane Database of Systematic Reviews, Issue 4, art. No. CDoo3401. Hurley, R., Cohen, S., & Wu, C. (2010). Acute pain in adults. In S. Fishman, J. Ballantyne, & J. Rathmell (Eds.), Bonica’s management of pain (4th ed., pp. 706–710). Philadelphia, PA: Wolters Kluwer-Lippincott Wliliams & Wilkinson. Institute for Safe Medication Practices [ISMP]. (2003). Patient controlled analgesia: Making it safer for patients. Retrieved from www.ismp.org/profdevelopment/PCA Monograph. PDF ISMP Medication Safety Alert. (2009, October). Beware of basal opioid infusions with PCA therapy. Nurse Advise–ERR , 7(10). Retrieved from http://www.ismp.org/Newsletters/ nursing/issues Joint Commission on Accreditation of Healthcare Organizations [JCAHO]. (2004). Patient controlled analgesia by proxy Sentinel Events Alert Issue 33. Oakbrook Terrace, IL: Author. Kirkbride, G., & Vermace, B. (2011). Smart Pumps: Implications for nurse leaders. Nursing Administration Quarterly, 35(2), 110–118. Lavand’homme, P. (2011). The progression from acute to chronic pain. Current Opinion in Anesthesiology, 24, 545–550. Macintyre, P. E., & Jarvis, D. A. (1996). Age is the best predictor of post-operative morphine requirements. Pain, 64, 357–364. Rockford, M., & DeRuyter, M. (2009). Perioperative epidural analgesia. In H. Smith (Ed.), Current therapies in pain. Philadelphia, PA: Elsevier. Schnabel, A., Poepping, D., Gerss, J., Zahn, P., & Pogatski-Zahn, E. (2012). Sex-related differences of patient controlled epidural analgesia for postoperative pain. Pain, 153, 238–244. Subramian, K., Subramaniam, B., & Stenbrook, R. (2004). Ketamine as an adjuvant to opioids: A quantitative and qualitative systematic review. Anesthesia & Analgesia, 99, 482–495.

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138 7. Acute Pain: Patient-Controlled Analgesia and Epidural Analgesia Thomas, J., & von Gunten, C. (2006). Pharmacologic therapies for pain. In J. Von Roenn, J. Paice, & M. Preodor (Eds.). Current diagnosis & treatment of pain (pp. 21–37). New York, NY: Lange Medical Books/McGraw-Hill. Vicente, K. J., Kada-Bekhaled, K., & Hillel, G. (2003). Programming errors contribute to death from patient-controlled analgesia: Case report and estimate of probability. Canadian Journal of Anaesthesia , 50, 328–332. Vila, H., Smith, R., Augustyniak, M., Nagi, P., Soto, R., Ross, T., . . . Miguel, R. (2005). The efficacy and safety of pain management before and after the implementation of hospital-wide pain management standards: Is patient safety compromised by treatment based solely on numerical pain ratings? Anesthesia & Analgesia, 101(2), 474–480. Wang, Y., Mullen, E., & Leung, J. (2006). Postoperative delirium: The importance of pain and pain management. Anesthesia & Analgesia , 102 (4), 1267–1273. Weir, V. (2005). Best practice protocols: Preventing adverse drug events. Nursing Management, 36(9), 24–30.

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SECTION III: INTERVENTIONAL OPTIONS FOR MANAGING ACUTE/CHRONIC PAIN

8 Regional Techniques

WHY ARE REGIONAL TECHNIQUES FOR PAIN MANAGEMENT IMPORTANT FOR WOMEN? Recent research has determined that osteoarthritis (OA), one of the major reasons for joint replacement, has a neuropathic element to the chronic pain created by ongoing inflammation. OA is also more common in women than men (Boyan et al., 2012; Nicolella et al., 2012). A local anesthetic using a peripheral nerve catheter is one of the recommended methods for treating the pain of total joint replacement, and women can benefit from the use of regional techniques for postoperative pain management after total knee replacement. OA among women is a bigger problem than most Americans realize. OA affects approximately 26.9 million persons in the United States (Boyan et al., 2012). The disease affects more women than men, and the disability and pain associated with OA of the knee is much greater in women (O’Connor & Hooten, 2011). Women lose knee cartilage more quickly than men, which can be explained by some of the sex-related differences in knee physiology. Knee tissue is modulated by sex hormones throughout the life of the patient. Although menopause is linked to increased OA in women, there are differences in the number of hormone receptor sites in women’s knees (Boyan et al., 2012). Women report more pain postoperatively, more intense pain overall, and reduced activities of daily living when compared to men (Novicoff & Saleh, 2011). Even after surgery, the intense pain of the knee may not resolve entirely. It is critical then for women to be presented with options for the very best of postoperative pain relief. These include the use of patient-controlled analgesia (PCA) and peripheral nerve catheters to most effectively block the pain after total joint replacement, which is the most common treatment for the joint destruction caused by OA.

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RATIONALE FOR USE OF REGIONAL ANALGESIA Since 30% to 80% of surgical patients report moderate to severe pain following surgery (Apfelbaum, Chen, Mehta, & Gan, 2003; McGrath, Elgendy, & Chung, 2004), it is important to provide the highest possible level of postoperative analgesia. This means the use of multiple techniques to control postoperative pain. The use of regional anesthesia has been recommended by the American Society of Anesthesiologists (ASA, 2004) as a means of extending the superior pain management of the operating room. There are two main techniques that are used: intraoperative neural blockade, which is a one-time procedure, and continuous delivery of regional anesthesia through peripheral nerve or wound catheters. Through use of either of these techniques, blockade or continuous infusion, opioid use can be minimized in the postoperative setting, resulting in fewer adverse effects. The level of pain relief with a regional analgesia technique is superior to opioids alone and reduces opioid-related side effects such as nausea, vomiting, sedation, and pruritus (Le-Wendling & Enneking, 2008; Liu & Salinas, 2003; Richman et al., 2006). In addition, the combined benefit is that pain relief and functionality are improved with the use of a peripheral catheter (PC), and improved functionality has been reported with PCs (Rosenquist & Rosenberg, 2003). There is also some indication that the use of regional anesthesia, epidurals, and regional analgesia has a positive impact on mortality and morbidity with high-risk patients (Hanna, Murphy, Kumar, & Wu, 2009). The current-day anesthesia provider has many more options for increasing the effectiveness of postoperative analgesia by extending the controlled anesthetic and analgesic techniques of the operating room into the postoperative time period. Using single injections for regional blockade, and inserting a PC that can provide extended adjunct pain relief can help the surgical or trauma patient recover faster with fewer side effects.

INTRAOPERATIVE BLOCKADE Intraoperative blockade can be used to reduce pain in the immediate postoperative time period. There are a variety of blocks that can be used, including: plexus, illioinguinal, penile, axillary, or femoral. The use of a blockade can extend the analgesia of the operating room into the first hours of the recovery time period. The disadvantage of using a single block is the limited effect. Postoperative one-time blocks can last for up to 24 hours but tend to wear off in a relatively shorter period of time (Hurley, Cohen, & Wu, 2010). The use of epinephrine in the block solution can help extend the action of the block.

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These single-dose intraoperative blocks can be placed in a wide variety of surgical locations. The blocks are designed to provide lack of sensation to the surgical area and they are done with a local anesthesia such as bupivacaine that can have extended action if epinephrine is included in the block solution. Solutions that are used for blocks are local anesthetics. Two percent (2%) lidocaine and 1.5% mepivicaine have a rapid onset combined with a short duration of action (Wallace & Staats, 2005). One-half percent (0.5%) bupivacaine, 0.75% ropivacaine, and 0.5% levobupivacaine have extended action but a slower onset time (Wallace & Staats, 2005). Areas that are commonly used for blockade include the following.

Axillary This block is used for upper-extremity surgery, such as shoulder surgery. It is used for procedures of the forearm, wrist, hand, chronic pain syndromes, and vascular diseases. It blocks the terminal branches of the brachial plexus.

Interscalene This block is commonly used for open-shoulder surgery, rotator cuff repair, acromioplasty, shoulder arthroplasty, and proximal upper-limb surgery (May & DeRuyter, 2009). The block performed is a brachial plexus block. When performed as a surgical adjunct this block may not produce analgesia for the ulnar nerve, the loading bolus may produce phrenic nerve block, and the patient can develop hoarseness from laryngeal blockade as well as Horner’s syndrome as a result of sympathetic blockade.

Femoral The femoral block is commonly used for surgeries of the knee and femur. Anesthesia of the anterior thigh, femur, and most of the knee joint is produced with a blockade. It can be combined with a sciatic block, which effectively blocks both the anterior and posterior aspects of the knee. These blocks have been most effective when a continuous local anesthetic infusion is used, leading to improved patient outcomes and fewer side effects in the postoperative time period. Careful assessment is needed to determine if there is muscle weakness in the lower extremity, primarily quadriceps muscle weakness, with the block before getting the patient out of bed to avoid buckling of the extremity. Some of the more important patient outcomes when this block is used are increased ability to move the

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142 8. Regional Techniques surgical joint, opioid-sparing pain management, decreased side effects such as postoperative nausea and vomiting, and increased patient satisfaction.

Sciatic A sciatic block provides anesthesia to the skin of the posterior thigh, hamstring, and part of the hip and knee joint, and the entire leg below the knee (with the exception of the skin). It can be combined with a femoral block for knee surgery or lumbar plexus block for hip and femur surgery.

Thoracic Paravertebral The thoracic paravertebral block is commonly used for surgeries of the breast, chest wall, and abdomen. Other uses for this type of block include anesthesia and/or analgesia for herniorraphy; iliac crest bone grafts; soft tissue mass excisions; and as an analgesic adjunct for laparoscopic surgery, cholecystectomy, nephrectomy, appendectomy, thorocotomy, obstetric analgesia, minimally invasive cardiac surgery, and hip surgery. Positive patient outcomes with this type of block include: reduction in pain scores, opioid-sparing effect, decreased postoperative nausea and vomiting, and decreased length of stay (May & DeRuyter, 2009; Melton & Liu, 2010; Wallace & Staats, 2005).

PERIPHERAL CATHETERS PCs FOR POSTOPERATIVE ANALGESIA In certain patient populations such as orthopedic total joint replacement patients, where high levels of pain are expected, using pain medications in conjunction with a PC (perineural catheter) infusion has become the accepted practice. The prior practice pattern for these orthopedic patients was to use epidural catheters for postoperative analgesia. The change in practice was partially stimulated by the focus on prophylactic anticoagulation in these patients and the recognition of increased potential for adverse effects such as epidural hematoma. The American Society for Regional Anesthesia (ASRA, 2002) developed a consensus statement related to anesthesiologist practice with epidural catheters and anticoagulation, which outlines recommendations for practice when epidural catheters are used for postoperative pain relief in patients receiving anticoagulants. As a result of this paper and the recognition of the increased risk of epidural hematoma with the use of epidurals and anticoagulants, the use of epidural catheters decreased dramatically over a period of a year or two.

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This decrease in epidural use made way for the development of alternate methods of pain control for total joint replacement patients using a combined medication, regional analgesia technique with PC. Since multimodal analgesia is always recommended as the best approach to postoperative pain management (ASA, 2004), this new technique is a good addition to the options that surgeons and anesthesia providers are able to offer patients. The PC is a catheter similar to an epidural catheter that can be placed as a soaker-hose configuration along the edge of a large incision to provide localized pain relief. The PC can also be placed along a nerve such as the femoral or sciatic nerve (or both for total knee replacement patients), or interscalene brachial plexus to provide continuous pain relief. With either type of placement the patient can expect to have the catheter remain in place while infusions of local anesthetic such as bupivacaine or ropivacaine infuse through the catheter. Most PCs use some type of infusion device to provide continuous flow. One example is the On-Q pump (Figure 8.1), an elastomeric device that can be configured to deliver a preset continuous flow but also has a component by which the patient can self-administer a bolus dose. During surgery the catheter is inserted into the area where the blockade is desired. A ball-shaped reservoir is filled with a local anesthetic solution and a rate is set by adjusting a knob at the top of the ball by the surgeon or anesthesia provider. The On-Q infusion is complete in several days depending on the rate by which the ball containing the medication collapses and is no longer firm to the touch. There are a variety of infusion devices available that work in basically the same fashion, and each has its own advantages and disadvantages. The additional option of a patient-controlled button device can allow the patient to provide a bolus dose of local anesthetic when needed.

PLACEMENT OF PC In order to place a peripheral nerve catheter, the anesthesia provider uses a hollow Touhy-type needle connected to a nerve stimulator or an ultra-sound. Once placement has been confirmed, the provider threads the catheter down the hollow center of the needle to the area that needs analgesia. To test placement, the provider confirms location with one of two techniques: ■ Nerve stimulator (NS) To locate the correct site for placement using an NS, the anesthesia provider uses a short, beveled, Teflon-coated needle inserted into the area for blockade and attached to a NS with a pulse duration of 0.15 ms. The correct nerves are located by the twitches elicited

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144 8. Regional Techniques

Figure 8.1 ■ On-Q pump.

by the stimulation. The stimulation intensity is reduced after the block is injected, the catheter is inserted, and the needle is removed. ■ Ultrasound-guided peripheral nerve block To locate the correct site for placement with ultrasound (US), a short, beveled, Teflon-coated needle is inserted into the area for blockade so that the entire shaft of the needle is in the US beam and both the shaft and the tip of the needle are visualized. Once the site is located, the injection is completed and the catheter is threaded through the needle. Spread of local anesthetic is confi rmed with continuous sonography. The onset of blockade with US has been reported as faster than the older NS technique. There is Level 1b evidence to make a Grade A recommendation for the use of US, as it improves the onset and success of the sensory blockade, decreases local anesthetic needs, and decreases time to perform lower-extremity blockade (Salinas, 2010). Indications are not

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entirely favorable of the use of US, including the same effects noted for tissue damage to neighboring structures and inadequate analgesia in a small number of patients (Le Wendling & Enneking, 2008). Nerves that can be blocked using continuous local anesthetic infusion for continued analgesia after surgery include those that were described earlier in the chapter on block locations. The risks with using a PC are very low. Nerve injury with blocks is estimated to be 0% to 10% with upper extremity single-shot blocks and 0.5% with lower-extremity blocks (Melton & Liu, 2010). Systemic local anesthetic toxicity is reported as rare (Bleckner et al., 2010). Pneumothorax rates are reported as low with both interscalene and paravertebral blocks. Infections with blocks and catheters are rare, and the ASRA has recommended the use of aseptic technique for catheter placements with monitoring of infections. The use of local anesthetic catheters has moved into new areas and found acceptance in the popular press. In 2006 the New York Times reported on an anesthesiologist who recognized the positive benefits of using local anesthetic infusions to help relieve battle wounds in the leg and arm. He used a small compact infusion pump with local anesthetic as adjunct pain relief for soldiers in military hospitals. This technique allowed for immediate decreases in pain and helped continue pain relief as the soldiers were transported to other military facilities for surgery or rehabilitation. A PC should always have a secondary method of pain relief such as PCA or intermittent IV analgesic in case of PC failure or dislodgement. The value of using a PC is related to the use of two different types of analgesia—multimodal analgesia using local anesthetic in the pump and intravenous opioids, an opioid-sparing effect, and a reduction in side effects such as nausea. Increases in patient satisfaction, though difficult to determine, have been reported with the use of PCs, along with the benefit of decreased length of stay. Meta-analyses have shown a reduction of 1 day of hospitalization (Liu, Richman, Thirlby, & Wu, 2006). Technical failure is rare (1%), and local anesthetic toxicity (0%) with wound infection rates are below control group rates (0.7%) (Liu et al., 2006). Given that the cost of the pump is low, ranging from $200 to $280 dollars per patient (Ilfeld et al., 2009), and the outcomes are very good, this economical local anesthetic infusion option provides added benefit for patients, health care providers, and hospitals, and has dramatically improved postoperative pain management.

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146 8. Regional Techniques Case Study Cecilia is a 64-year-old patient with severe OA of the knee. She has been controlling her pain with daily nonsteroidal anti-inflammatory drugs (NSAIDs), a topical cream, and rest. She has extremely limited mobility and cannot get to her church or go shopping. She rates her pain as greater than 5/10 on most days. When her knee swells she puts ice on it and takes a Vicodin tablet to decrease the pain. She does not like using opioids, and as her world gets smaller and smaller, she realizes she needs to get help for her knee. She has an appointment with an orthopedist who recommends total knee replacement for both knees. Cecilia has the option of doing one knee at a time or both together. She is so debilitated that she opts for the bilateral knee replacement, hoping to relieve her pain and increase her functionality, leading to a better quality of life. Cecilia is worried about her postoperative pain. What can you tell Cecilia about what is available for postoperative pain relief that will ease her mind?

Questions to Consider 1. Since epidural catheters are not commonly used for total knee replacement, what other options would be available to help Cecilia with her postoperative pain? PCA? Nerve catheter? Oral pain medications? 2. Why is the pain level that Cecelia is experiencing so much more severe than her brother, who has the same problem? 3. What is the advantage of using a peripheral nerve catheter as additive pain relief for a surgery such as a total knee replacement?

REFERENCES American Society of Regional Anesthesia and Pain Management. (2002). Consensus statement: Regional anesthesia in the anticoagulated patient: Defining the risks. Retrieved from www.asra.com/consensus-statement/2.html American Society of Anesthesiologists. (2004). Practice guidelines for acute pain management in the perioperative setting. Anesthesiology, 100(6), 1573–1581. Apfelbaum, J. L., Chen, C., Mehta, S. S., & Gan, T. (2003). Postoperative pain experience: Results from a national survey suggest postoperative pain continues to be undermanaged. Anesthesia & Analgesia , 97, 534–540.

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Bleckner, L., Bina, S., Kwon, K., McKnight, G., Dragovich, A., & Buckenmaier, C. (2010). Serum ropivacaine concentrations and systemic local anesthetic toxicity in trauma patients receiving long-term continuous peripheral nerve block catheters. Regional Anesthesia , 110 (2), 630–634. Boyan, B., Tosi, L., Coutts, R., Enoka, R., Hart, D., Nicolella, D., . . . Kohrt, W. (2012). Sex differences in osteoarthritis of the knee. Journal of the American Academy of Orthopaedic Surgeons, 20, 668–669. Hanna, M., Murphy, J., Kumar, K., & Wu, C. (2009). Regional techniques and outcome: What is the evidence? Current Opinion in Anesthesiology, 22, 672–677. Ilfeld, B., Le, L., Ramjohn, J., Loland, V., Wadhwa, A., Gerancher, J., . . . Mariano, E. (2009). The effects of local anesthetic concentration and dose on continuous intraclavicular nerve blocks: A multicenter, randomized, observer-masked, controlled study. Regional Anesthesia, 108(1), 345–350. Le-Wendling, L., & Enneking, F. K. (2008). Continuous peripheral nerve blockade for postoperative analgesia. Current Opinion in Anesthesiology, 21, 602–609. Liu, S., Richman, J., Th irlby, R., & Wu, C. (2006). Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: A quantitative and qualitative systematic review of randomized controlled trial. Journal of the American College of Surgeons, 203 (6), 914–932. Liu, S., & Salinsa, F. (2003). Continuous plexus and peripheral nerve blocks for postoperative analgesia. Anesthesia & Analgesia, 96(1), 263–272. May, M., & DeRuyter, M. (2009). Perioperative epidural analgesia. In H. Smith (Ed.), Current therapies in pain. Philadelphia, PA: Elsevier. McGrath, B., Elgendy, H., & Chung, F. (2004). Th irty percent of patients have moderate to severe pain 24 hours after ambulatory surgery: A survey of 5,703 patients. Canadian Journal of Anesthesia , 51, 886–891. Nicolella, D., O’Connor, M., Enoka, R., Boyan, B., Hart, D., Resnick, E., . . . Kohrt, W. (2012). Mechanical contributors to sex differences in idiopathic knee osteoarthritis. Biology of Sex Diff erences, 3, 28–35. Novicoff, W., & Saleh, K. (2011). Examining sex and gender disparities in total joint arthroplasty. Clinical Orthopaedics and Related Research, 469, 1824–1828. O’Connor, M., & Hooten, E. (2011). Gender disparities in knee osteoarthritis and TKS. Clinical Orthopaedics and Related Research, 469, 1883–1885. Richman, J., Liu, S., Courpas, G., Wong, R., Rowlingsen, A., McGready, J., . . . Wu, C. (2006). Does continuous peripheral nerve block provide superior pain control to opioids? A meta-analysis. Anesthesia & Analgesia , 102 (1), 248–257. Rosenquist, R., & Rosenberg, J. (2003). Postoperative pain guidelines. Regional Anesthesia, 28 (4), 279–288. Salinas, F. (2010). Ultrasound and review of evidence for lower extremity peripheral nerve blocks. Regional Anesthesia and Pain Medicine, 35(2, Suppl. 1), S16–S24.

ADDITIONAL RESOURCES Capdevila, X., Bringuier, S., & Borgeat, A. (2009). Infectious risk of continuous peripheral nerve blocks. Anesthesiology, 100, 182–188.

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148 8. Regional Techniques Casati, A., Danelli, G., Baciarello, M., Corradi, M., Leone, S., DiCianni, S., & Fanelli, G. (2009). A prospective, randomized comparison between ultrasound and nerve stimulation guidance for multiple injection axillary brachial plexus block. Survey of Anesthesiology, 53(4), 186–189. Fingerman, M., Benonis, J., & Martin, G. (2009). A practical guide to commonly performed ultrasound-guided peripheral-nerve blocks. Current Opinion in Anesthesiology, 22, 600–607. Indelli, P. F., Grant, S., Neilsen, K., & Parker, T. (2005). Regional anesthesia for hip surgery. Clinical Orthopedic and Related Research, 441, 250–255. McGough, R. (2006, June 13). Pain pump tested in battle. The Wall Street Journal. McGrath, B., Elgendy, H., & Chung, F. (2004). Th irty percent of patients have moderate to severe pain 24 hours after ambulatory surgery: A survey of 5,703 patients. Canadian Journal of Anesthesia, 51, 886–891. Melton, S., & Liu, S. (2010). Chapter 52. In S. Fishman, J. Ballantyne, & J. Rathmell (Eds.), Bonica’s management of pain (5th ed.). Philadelphia, PA: Lippincott. O’Connor, M. (2007). Sex differences in osteoarthritis of the hip and knee. Journal of the American Academy of Orthopedic Surgeons, 15, S22–S25.

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9 Implanted Techniques

Implanted techniques for pain management should never be a first-choice option. They are meant to contribute to pain relief, but they are a part of a multidisciplinary plan of care that requires careful attention and oversight once the modality is placed into the patient. Women may not consider these options and try many other therapies before they are referred for an evaluation for either an implanted pump or a spinal cord stimulator (SCS). Many of the pain conditions that women experience may not be amenable to implanted techniques, but others are good choices when the pain becomes intractable to other forms of treatment. Women with postherpetic neuralgia (PHN) and some pelvic conditions are worth evaluating for implanted SCS. For example, patients with interstitial cystitis and vulvodynia can consider an SCS if all else has failed and if there is hope of placing the stimulator catheter in the area of pain generation. Implanted pumps can be considered for women with failed back syndrome if all other therapies have been ineffective and the patient has tried a variety of opioid medications without good outcomes. The key to success is a comprehensive evaluation that includes not only a pain review but a psychosocial evaluation to investigate possible comorbid conditions such as depression that need treatment concomitantly. Once the patient has been cleared for placement, maintaining realistic expectation for the therapy will help the patient adjust to the new implant.

IMPLANTED MODALITIES Intrathecal drug delivery systems (see Figure 9.1) are used to control chronic pain in patients who have exhausted all other medication management and maximized medication doses. This technique is not a first-line option and requires considerable use of other techniques for pain management before consideration of an implanted pump. The implanted pump has a catheter that is placed directly into the intrathecal space of the spine, 149

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Figure 9.1 ■ Intrathecal pump.

allowing for small amounts of medication to be delivered continuously, providing enhanced pain relief. The technique consists of an implanted computerized pump that automatically delivers a prescribed dose of medication at a set rate. The pain practitioner uses a trial of medication doses before the final implantation to determine which dose of medication will be most effective to control the pain. The computer inside the pump is then set to deliver this dose automatically. The medication is delivered from the pump reservoir into the intrathecal space by a flexible catheter that is tunneled from the spinal insertion point along the lateral aspect of the patient’s body and connected to the pump. The pump is placed in a pocket in abdominal or other subcutaneous tissue close to the skin’s surface to make refilling the pump easier. Pump refills are done when needed according to the medication concentration and the infusion rate of the medication. A refill kit with a specialized needle is used to withdraw any leftover medication from the pump reservoir and new medication is inserted. The pump refill date is then reset to a new date that is determined by the concentration of the medication and medication delivery rate.

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Medications that are FDA approved for use in implanted intrathecal pumps are: ■ Morphine ■ Baclofen ■ Zinconitide (Prialt) All medications used in implanted intrathecal pumps should be preservative-free. Morphine is the most common medication, and using an intrathecal medication delivery can provide morphine doses that are 300 times as potent as oral morphine (Wallace & Staats, 2005). Before the pump is permanently implanted, a trial will be performed using the anticipated medication. During the trial period, the drug and dose selection are based on: ■ History of opioid tolerance ■ Side-effect history ■ Pain afferent spinal cord level compared with catheter tip location (Wallace & Staats, 2005) The lipophilicity of the selected pain medication and the available lipid supply of the spinal cord, the accessibility of the cerebrospinal fluid, and blood supply can directly affect the analgesic action of the medication being used (Wallace & Staats, 2005). Morphine is classed as a hydrophilic medication, while fentanyl is classed as a lipophilic medication. This hydrophilic property of morphine allows it to distribute itself widely in the cerebrospinal fluid. Prialt is a one-of–a-kind medication classed as a neuronal-type (N-type) calcium channel blocker. It is derived from the venom of the cone snail, a marine snail. Prialt must be administered intracthecally using a continuous infusion (Lynch, Cheng, & Lee, 2006). It can be used to treat both chronic and neuropathic pain (Schroeder, Doering, Zamponi, & Lewis, 2006). There are some specific side effects, mainly neuropsychiatric, that can be significant. These include: ■ Depression ■ Cognitive impairment ■ Depressed levels of consciousness ■ Hallucinations ■ Elevated creatinine kinase levels (Lynch et al., 2006) Prialt use should be reserved for patients who have failed all other more conventional medications and interventions. Anecdotally, practitioners are using other medications such as hydromorphone and local anesthetics in implanted pumps when pain is not controlled with standard medications, but the risk of pump dysfunction increases when unapproved medications are used in these pumps.

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SELECTING A CANDIDATE FOR INTRATHECAL THERAPY Before implanting an intrathecal pump, the patient should be given a thorough evaluation. In order to be considered a good candidate, the criteria shown in Exhibit 9.1 should be considered. The use of an intrathecal medication delivery system can have any number of problems and complications (Exhibit 9.2). The patient risk– benefit ratio should be carefully weighed and all other reasonable options Exhibit 9.1

Selecting a Candidate for Intrathecal Medication Delivery

■ Ineffective oral analgesia with multiple oral or transcutaneous trials

including dose titration Intolerable side effects despite opioid rotation Functional analgesia during temporary trial infusion Psychological stability and reasonable goals Access to care (the patient will return to the pain clinic for pump refills and dose adjustments) ■ Patient acceptance ■ For baclofen: intractable spasticity unrelieved by oral antispasmodics, but improved spasticity with baclofen test dosing (From Wallace & Staats, 2005, p. 342) ■ ■ ■ ■

Exhibit 9.2

Risks and Considerations With Intrathecal Medication Administration

■ Does the patient have any placement issues such as spinal deformity,

past spinal surgery, or abdominal surgery that would make placement difficult? ■ All patients are at risk of infection, meningitis, arachnoiditis, and catheter-related granuloma formation ■ Anticoagulation can cause a compressive hematoma when the catheter is being placed or removed ■ Pump malfunction can cause a withdrawal syndrome ■ Risk of low-pressure spinal headaches ■ Need for dose escalation and the development of tolerance (Adapted from Wallace & Staats, 2005)

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should be tried before pump implantation is tried. If the patient does not have a 50% reduction in pain levels with the pre-pump implantation trial, the final implantation should be reconsidered. There are some risks that the patient should be aware of before the catheter is placed. The decision to implant a device of any type into a patient should be carefully considered. Only when the patient, family, and practitioner agree that the implantation will improve pain relief and increase the patient’s quality of life should the technique be used.

SPINAL CORD STIMULATION Although the mechanism of SCS is poorly understood at this time, it is best represented as a technique that uses the gate control theory of pain for pain relief. In the gate control theory, repeated painful stimuli open the gate for pain transmission. SCS can selectively depolarize large fiber afferents in the dorsal columns of the spinal cord, closing the gate without causing motor effect (Wallace & Staats, 2005). It is also considered that the sympathetic nervous system is activated by pulse generation of the stimulator, and that additional neuronal pathways may be activated to provide additional pain relief (Wallace & Staats, 2005). Simplistically, the device consists of an implanted pulse generator (Figure 9.2); similar in size to a cardiac pacemaker, that delivers electrical pulses to a lead located in the targeted spinal cord area, the area that is

Figure 9.2 ■ Spinal cord stimulator.

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154 9. Implanted Techniques Exhibit 9.3 Criteria for Appropriate Patient Selection for SCS ■ All acceptable and less-invasive treatment options should be exhausted ■ The patient should have a psychiatric evaluation to assess for any

psychiatric comorbidities, any issues of substance abuse, and any potential for secondary gain ■ A diagnosis should be established for the pain ■ Text stimulation trials indicate a good level of pain relief and functional improvement (adapted from Wallace & Staats, 2005; Position Statement, NTAC, 2008)

painful (Mailis-Gagnon, Furlan, Sandoval, & Taylor, 2008). The generator is attached to a lead or leads that are implanted into the epidural space at the site of pain generation either percutaneously or through a laminectomy. When the system is activated, the patient will feel a tingling sensation over the affected or painful area. The SCS feeling is often compared to the tingling feeling of a transcutaneous electrical nerve stimulation (TENS) unit. As with use of intrathecal pumps, patients who are being considered for SCS should be carefully evaluated (Exhibits 9.3 and 9.4). The SCS will require the patient to be more involved in the operation, since the patient will have to identify the exact location of the tingling sensation during the trial and implantation, and will also have the ability to turn the stimulator on and off. SCS is considered to be a useful form of pain relief for patients with: ■ Failed back syndrome, pain continuing despite operative procedures to relieve the source of the pain ■ Chronic, intractable pain of the trunk or limbs ■ Chronic neuropathic pain, including complex regional pain syndrome (CRPS), phantom pain, painful diabetic neuropathy (PDN), and postherpetic neuralgia (PHN) (Mailis-Gagnon et al., 2008; Neuromodulation Therapy Access Coalition [NTAC], 2008) Patients who are being considered for SCS should undergo a very thorough physical and psychological examination. They should also have used medication management and tried combinations and doses of medication with limited results. Although the research results are mixed and limited, the technique is a treatment option covered by Medicare and other governmental health care programs, all major commercial health plans, and most Workers’ Compensation plans in the United States (NTAC, 2008). The chance that SCS will work and increase function is an outcome that should be considered if the trial stimulation relieves pain. The last positive aspects of SCS are that it is minimally invasive; reversible; nondestructive;

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Other Therapies

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Exhibit 9.4 Contraindications for SCS ■ ■ ■ ■ ■ ■ ■ ■

Coagulopathy Sepsis Untreated major comorbidity such as depression Serious drug or behavior problem Inability to cooperate or control the device Secondary gain Demand cardiac pacemaker MRI needs (Wallace & Staats, 2005)

and that the lead(s) and generator can be explanted if the technique does not provide the expected result (NTAC, 2008). With both implant techniques, patient selection and preimplantation medication manipulation and dose adjustment should all be tried prior to considering an implanted modality. Once the patient receives an implanted device, the pain clinic practitioner and the patient are very closely linked and frequent pain clinic visits should be expected. The patient’s ability to adjust to the tingling sensation in place of the pain and use the hand-held programmer to control the strength of the stimulation is critical to the success of the SCS.

OTHER THERAPIES Less commonly, procedures that affect nerve roots, such as radiofrequency lesioning, or specific muscle groups, such as prolotherapy, may be used. For most of these techniques, the intervention is placed directly at the source or site of the pain. There is limited research available, and support may not be strong for these techniques as a result. This does not mean the techniques have no value, just that the literature to provide research support may be too sparse. These are not first-line therapies and are just options that some pain specialists have found to be helpful for pain relief.

Prolotherapy, or Regenerative Injection Therapy (RIT) Prolotherapy, the injection of an irritant solution, such as dextrose/phenol/ glycerine or pumice, into weakened back muscles has been found to be an effective means of pain relief when combined with an aggressive physical therapy regimen (Robago, Yelland, Patterson, & Zgierska, 2011). If

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156 9. Implanted Techniques aggressive physical therapy is not used with the injection, the results will be significantly less positive. This technique has been tried for pain relief in many conditions, including: ■ Discogenic back pain ■ Chronic pain from ligaments or tendons from repetitive motion disorder ■ Osteoarthritis ■ Cervical, thoracic, lumbar, lumbosacral, and sacroiliac instability (Linetsky et al. in Wallace & Staats, 2005) Prolotherapy is a second- or third-line option for relieving chronic pain. Some patients have reported that the injection itself is painful and others have not been able to sustain the physical therapy that is required.

Radiofrequency Lesioning, Intradiscal Electrothermal Therapy (IDET) This group of therapies uses a heated probe to transect the nerve in the painful area. This practice has provided anecdotal reports of pain relief for discogenic back pain. In a randomized, double-blind, controlled trial of IDET versus placebo, the study findings revealed no significant benefit for the IDET patients over the placebo group (Freeman, Fraser, Cain, Hall, & Chappie, 2005). Again, this type of therapy should not be used as a firstline option, but reserved for use when other pain management options have failed to provide adequate pain relief.

Epiduroscopy Epiduroscopy involves the insertion of a scope into the epidural space of the spine. Attached to the scope are tools that can be used to remove scar tissue from nerve roots. The technique has been tried with limited success. There is insufficient research to indicate if the risk–benefit ratio of this technique merits its use.

RETURNING THE PATIENT TO THE REFERRING PRACTICE When the patient returns to the referring practice after treatment by a pain clinic, it is essential that the practice let the patient know that they are comfortable with the treatment regimen that the pain clinic specialist has prescribed. By presenting a united front to the patient, there is little room for any deviation from the plan unless the practitioners and patient agree to an adjustment.

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Establishing good communication with the pain clinic specialist will be especially important once the patient is no longer being seen in the first clinic. If the practitioner who refers the patient has a good understanding of the medication or therapy regimen, there is no reason that the primary care provider cannot provide the same level of pain management care. It is also important for the two practitioners to have access to current records if needed to confirm medications, dosages, and any adjustments that were made to the plan of care.

Case Study Candace is a 56-year-old teacher who has vulvodynia. She has intense burning pain in her vulvular area that extends into her vagina. She reports the pain as significant at 6/10. No medication she has tried seems to work. The pain has destroyed her quality of life and she can no longer work. It is just a constant entity in her daily life. Her sleep is disrupted and she has not had sexual relations with her husband for 3 years. Candace has considered surgery but would like to try an SCS to see if it would have any effect on her pain. She likes the idea that it is reversible and that she could control the amount of stimulation needed. She realizes it would not really take away her pain but mask it with a nonpainful stimulus. The stimulator would need to reach the sacral nerves to be effective, but she is willing to try it as a lastditch effort to get some control over the pain. She needs to make a decision but is still reluctant to commit to the procedure. What can you tell Candace about this technique to control her pain? Her current medications include amitriptyline and a topical anesthetic cream for increased pain.

Questions to Consider 1. What are the risks and benefits for Candace with this type of technique? 2. Is Candace a good candidate for SCS? 3. If the SCS drops her pain levels by several points and she can sleep better, would it be a worthwhile option for improving her pain relief?

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158 9. Implanted Techniques

HELPFUL WEBSITE/RESOURCE American Academy of Pain Medicine

www.aapm.org

REFERENCES Freeman, B., Fraser, R., Cain, C., Hall, D., & Chappie, D. (2005). A randomized, double blind, controlled trial: Intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine, 30 (21), 2369–2377. Lynch, S. S., Cheng, C. M., & Yee, J. L. (2006). Intrathecal ziconotide for refractory chronic pain. Annals of Pharmacotherapy, 40 (7–8), 1293–1200. Mailis-Gagnon, A., Furlan, A., Sandoval, J. A., & Taylor, R. (2008). Spinal cord stimulation for chronic pain. The Cochrane Database of Systemic Reviews, (3), CD003783. Neuromodulation Therapy Access Coalition. (2008). Position statement on spinal cord neuromodulation. Retrieved from www.aapm.org Rabago, D., Yelland, M., Patterson, J., & Zgierska, A. (2011). Prolotherapy for chronic musculoskeletal pain. American Family Physician, 84(11), 1208–1210. Schroeder, C. I., Doering, C. J., Zamponi, G. W., & Lewis, R. J. (2006). N-type calcium channel blockers: Novel therapeutics for the treatment of pain. Medicinal Chemistry, 2 (5), 535–543. Wallace, M., & Staats, P. (2005). Pain medicine and management (pp. 285–288). New York, NY: McGraw-Hill.

ADDITIONAL RESOURCES American Academy of Pain Medicine, American Pain Society. (1997). The use of opioids for the treatment of chronic pain. Glenview, IL: The APS Society. American Pain Foundation. (2005). Pain facts: An overview of American pain surveys. Chou, R., & Huff man, L. (2007). Medications for acute and chronic low back pain: A review of evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline. Annals of Internal Medicine, 147(7), 505–514. D’Arcy, Y. (2007). Pain management: Tools and techniques for nursing professionals. Marblehead, MA: HCPro. International Association for the Study of Pain website. Retrieved November 2008 from www.iasp.org McCarberg, B. H., Nicholson, B. D., Todd, K. H., Palmer, T., & Penles, L. (2008). The impact of pain on quality of life and the unmet needs of pain management: Results from pain sufferers and physicians participating in an Internet survey. American Journal of Therapeutics, 15(4), 312–320.

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10 Labor and Delivery Pain Management Options

The pain of labor and delivery (L&D) has been graphically portrayed to generations of women. The concept of labor pain differs in cultures and ethnicities. Some women are encouraged to have their babies "naturally" without the benefit of pain medications or interventions, while other groups of women prefer to use every pain-relieving measure possible. In reality, what is possible for pain relief lies somewhere between the two approaches. Today’s approach to pain relief during L&D can include the best in high tech, such as the epidural, added to complementary techniques such as breathing exercises, relaxation, or acupuncture. The best combination is something that is individualized for each woman. What we do know about L&D is that we have two patients, the mother and the infant. One of the newest and least-studied aspects of labor pain is genetic polymorphism, which could indicate a predisposition to pain with labor. One study looked at the pain protective action of a single-nucleotide polymorphism (SNP) combination at the GCH1 gene, which might make some women less sensitive to pain as the cervix dilates in early labor. The aim of the study was to determine if there was an association between this SNP combination and pain behavior-related outcomes of labor (Dabo, Gronbladh, Nyberg, Sundstrom-Poromaa, & Akerud, 2010). Genotyping was performed on 814 women by gestational week 18. The findings indicated that only homozygous carriers of the SNP combination at GCH1 had reduced pain during cervical dilation, but after that period of time the patients were similar in their need for analgesia for reducing labor pain (Dabo et al., 2010). This research is extremely rudimentary and incomplete, but suggests being able to predict who will have more severe pain with future studies on genetic characteristics and pain behaviors.

159

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160 10. Labor and Delivery Pain Management Options

PAIN DURING CHILDBIRTH In most cases, women who are pregnant are happy to be having a baby and eagerly await the birth of the baby. However, there is a nagging fear of the pain that accompanies childbirth. Many have heard stories from relatives and friends and various solutions have no doubt been offered. In a study of both nulliparous and parous women using the McGill Pain Questionnaire, pain scores for labor rated 8 to 10 points higher than pain with cancer, phantom limb pain, and postherpetic neuralgia pain (Melzack, 1984). What causes the pain of childbirth? During the first stages of labor the cervix and lower uterus are the pain generators. In this first stage, the dilation of the cervix and stretching, distension, and tearing of tissues causes the first pain of childbirth. As labor progresses and the fetus descends lower into the birth canal, tearing of vaginal and perineal tissues contributes to the increasing pain. The pain of labor is not solely generated by the nociceptive receptors for pain, but is also produced by sympathetic neural mechanisms in the lumbar spinal segments (Wong, 2010). There have been differences in pain reported by nulliparous women and parous women, with nulliparous women reporting significantly more pain. Most women expect to have pain during L&D, but are anxious about the extent of the pain they might experience. Patient education and predelivery Lamaze classes can help alleviate some of the anxiety related to anticipated pain. In addition, prenatal discussions about options for pain relief can help to relieve anxiety related to the expected pain experience during L&D.

ANALGESIC OPTIONS FOR PAIN CONTROL DURING CHILDBIRTH There are a variety of options available for managing the pain of L&D. Having two patients, one a highly sensitive fetus, can complicate the use of opioids. Respiratory patterns in the laboring woman affect oxygen levels in the fetus. The strain of labor activates the sympathetic nervous system, causing epinephrine and norepinephrine levels to increase by 200% to 600% during an unmedicated labor (Wong, 2010). Additionally, cardiac stress is increased as labor progresses. Pregnancy can alter some of the normal pain responses. During pregnancy, substance P levels are lower, and pain thresholds are increased during both pregnancy and labor (Wong, 2010). Tissues in the nervous system tend to be more susceptible to multiple anesthetic or analgesic agents. These changes can help to facilitate analgesia for labor. The option to use nonopioid medications during labor has been reported by the Cochrane reviews. In one systematic review comprising 21 research

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studies involving 2,863 women where nonsteriodal anti-inflammatory drugs (NSAIDs), paracetamol, antispasmodics, and antihistamines were used as analgesics with the intent of reducing anxiety during labor, they were postulated to decrease pain (Othman, Jones, & Neilson, 2012). For any of the medication choices, the women rated the drugs as superior to placebo. However, the women were less likely to be satisfied with their analgesia during labor (Othman, Jones, et al., 2012). Of note, the majority of these studies were done over 30 years ago. In another Cochrane review, epidural versus nonepidural or analgesia was compared during labor. This systematic review included 9,658 women from 38 studies. Epidural analgesia is a technique using a combination of local anesthetic and opioids placed into the epidural spinal space using a needle for insertion. Epidurals are widely used for pain relief both during labor and during delivery. A lower concentration of local anesthetic can be given with an opioid to allow the laboring woman to ambulate. In the Cochrane epidural review, the use of the technique proved to provide superior pain relief but it led to the use of more instrumentation for delivery. There was no increase in the rates of caesarean deliveries, the babies did not suffer any adverse effects from the use of the epidural, and fewer babies required the use of naloxone to reverse opioid effects. However, there were some drawbacks with the use of epidurals during labor, which include: ■ Longer labor times ■ Need for oxytocin to stimulate contractions ■ Experience of low blood pressure ■ Inability to move for a period of time after delivery ■ Difficulty urinating ■ Postdelivery fever (Anim-Somuah, Smyth, & Jones, 2011) Additionally, long-term backache rates were no different with epidural use. Since epidurals are used so commonly, several studies have looked at what type of delivery is the best approach. In a meta-analysis of nine studies with 640 patients, reviewing the use of patient-controlled epidural analgesia (PCEA) versus continuous infusions (CI), the findings indicate that patients who receive PCEA are less likely to require intervention and require lower doses of local anesthetic, resulting in less motor block (van der Vyver, Halpern, & Joseph, 2002). In another study looking at the use of epidural labor modalities, PCEA was found to have an opioid-sparing effect with an overall decrease in infusion dose. In the area of maternal satisfaction, the woman liked the ability to use PCEA (Vallejo, Ramesh, Phelps, & Sah, 2007). Other factors evaluated, such as interventions, pain, and labor duration, were not found to be significant.

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162 10. Labor and Delivery Pain Management Options So what has been found to be the best options for controlling L&D pain? In a Cochrane meta-systematic review that included Cochrane reviews and three non-Cochrane reviews, in the types of analgesia that provided the best analgesic options for women, the evidence indicates that epidural, combined spinal epidural, and inhaled analgesia can manage pain in labor, but have the downside of adverse effects such as nausea and vomiting with inhaled agents (Othman, Dowswell, et al., 2012). Less evidence has been found to support the use of water immersion, relaxation, acupuncture, massage, and local anesthetic nerve blocks or nonopioid medications (Othman, Dowswell, et al., 2012). Relaxation and acupuncture had the strongest evidentiary support, but the evidence was derived from single studies. Pain relief options with insufficient evidence to recommend use include: hypnosis, biofeedback, sterile water injection, aromatherapy, transcutaneous electrical nerve stimulation (TENS), and parenteral opioids. These interventions do not have enough evidentiary support to recommend their use over placebo (Othman, Dowswell et al., 2012). When women who have delivered babies using nonpharmacological methods were questioned, they highlighted the presence and support of their partners as being a major source of comfort during the labor experience (Brown, Douglas, & Flood, 2001). Of the nonpharmacological techniques, breathing techniques, relaxation, acupressure, and massage were found to be the most effective (Brown et al., 2001). These findings indicate that patients are interested in learning about pain management options and that prenatal education generally is helpful for patients who are near delivery. Many patients in the Brown study indicated they feared the experience of giving birth, so it is a great opportunity for educators to help reduce anxiety and relieve fear by providing information on pain management options during the L&D period.

POSTDELIVERY PAIN RELIEF OPTIONS Once the baby is born, the postdelivery period is also a time when pain control options need to be carefully considered. Most oral medications the mother takes can pass across the barriers and be excreted in breast milk. For this reason, the safest recommendation is the use of acetaminophen or NSAIDs for pain relief (Wong, 2010), but that may not provide enough pain control as needed by the individual mother. Most opioids are considered to be acceptable for pain relief, but there is a concern for patients who metabolize these drugs rapidly. There is a new black box warning for the use of acetaminophen with codeine in nursing mothers who rapidly metabolize drugs. If the metabolite conversion is rapid enough,

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newborn infants being breastfed are being exposed to high doses of morphine converted from the codeine. This can lead to infant death. For this reason, nursing mothers are warned against using acetaminophen with codeine. One special class of mothers that require special care and attention are opioid-dependent pregnant women. They may face tremendous pressures from family, friends, and health care providers to stop or cut down on opioid use during pregnancy. They also face the effect of their pain medications on the unborn fetus and the fact that the baby may be born opioid-dependent as well. For health care providers working with these patients, it is critical to obtain an accurate history of current opioid use. Patients who are on methadone maintenance for addiction are recommended to stay on it to avoid the risk of stillbirth, fetal distress, and premature delivery (Jones et al., 2008). All opioids are listed as Class C for risk in pregnant women. It is incumbent on the health care provider to ascertain the patient’s status and weigh the risks and benefits of any opioids being used by the patient during pregnancy and in the post delivery time period.

THE ROLE OF THE NURSE DURING L&D The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) has issued a position statement on the role of the nurse during L&D when epidural analgesia is being used. In general, the statement says that the nurse must function within the scope of practice defined by the state in which he or she practices. AWHONN views the role of the nurse caring for these women to include: ■ Monitor vital signs, level of mobility, level of consciousness, perception of pain, and level of pain relief ■ Monitor fetal status ■ Pause the infusion to replace syringes or bags with the same concentration and medication as ordered by the anesthesia provider ■ Stop the continuous infusion if there is a safety concern or the woman has given birth ■ Remove the catheter if properly educated to do so ■ Initiate emergency therapeutic measures if complications arise according to policies, protocols, and RN scope of practice ■ Communicate clinical assessments and changes in patient status to obstetric and anesthesia care providers as indicated by policy ( AWHONN, 2012) There are also practices that AWHONN states should not be performed by the nurse: ■ Bolus or rebolus, regional/intrathecal analgesia, or anesthesia doses by injecting medications into the catheter ■ Manipulate doses of regional/intrathecal medication by continuous or PCEA

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164 10. Labor and Delivery Pain Management Options ■ ■ ■

Increase or decrease the rate of a continuous infusion Reinitiate an infusion once it has been stopped Be responsible for obtaining informed consent for analgesia or anesthesia procedures, for which the nurse may be the witness (AWHONN, 2012) Because the nurse caring for the laboring woman has two patients— the mother and fetus—plus family members, it is imperative that all care and safety be maintained. Also, pregnant women are very different from whom they are in their nonpregnant state, and this requires a careful assessment and special care with medication delivery via epidural. Because the L&D nurse cares for all the needs of the patient, she must be concerned about other medications and interventions, and leaving the care of the epidural catheter to the anesthesia provider who is also caring for the patient. Case Study Joanna is a 30-year-old secretary who is expecting her first baby. As she nears her due date she becomes somewhat withdrawn and is not as talkative as she once was. When her health care provider asks her about any problems, she blurts out that she fears giving birth. Her mother has been telling her about her horrendous L&D, and other relatives have shared their stories as well. Joanna fears she will not be able to tolerate the pain of L&D even though she wants this baby very much and looks forward to being a mother. Her husband is very supportive and has been trying to tell Joanna that things have changed a lot since her mother had her.

Questions to Consider 1. As the prenatal educator, what can you tell Joanna that will ease her fears about the L&D process? 2. Although Joanna decides to opt for a labor epidural, she is also interested in using some nonpharmacological methods for pain relief. What can you suggest to her? 3. Do you think a visit to the nursing unit would help Joanna be less fearful? 4. Would you consider showing Joanna films of successful labor/ delivery/births?

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References

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REFERENCES Anim-Soumuah, M., Smyth, R., & Jones, L. (2011). Epidural versus non-epidural or no analgesia in labour. The Cochrane Collaboration in the Cochrane Library, (12), CD000331. Association of Women’s Health, Obstetric and Neonatal Nurses. (2012). Role of the registered nurse in the care of the pregnant woman receiving analgesia and anesthesia by catheter techniques. AWHONN Position Paper. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 41, 455–457. Brown, S., Douglas, C., & Flood, L. (2001). Women’s evaluation of intrapartum nonpharmacological pain relief methods used during labor. Journal of Perinatal Education, 10 (3), 1–8. Dabo, F., Gronbladh, A., Nyberg, F., Sundstrom-Poromaa, I., & Akerud, H. (2010). Different SNP combinations in the GCH1 gene and use of labor analgesia. Molecular Pain, 6(41), 1–6. Jones, H., Martin, P., Heil, S., Kaltenbach, K., Selby, P., Coyle, M., . . . Fischer, G. (2008). Treatment of opioid dependent pregnancy women: Clinical and research issues. Journal of Substance Abuse Treatment, 35, 245–259. Melzack, R. (1984). The myth of painless childbirth (the John Bonica lecture). Pain, 19 (4), 321–337. Othman, J., Dowswell, T., Alfirevic, Z., Gates, S., Newburn, M., Jordan, S., . . . Neilson, J. (2012). Pain management for women in labor: An overview of systematic reviews. The Cochrane Collaboration, (3), CD009234. Othamn, M., Jones, L., & Neilson, J. (2012). Non-opioid drugs for pain management in labour. The Cochrane Collaboration in the Cochrane Library, (7), CD009223. Vallejo, M., Ramesh, V., Phelps, A., & Sah, N. (2007). Epidural labor analgesia: Continuous infusion versus patient-controlled epidural analgesia with background infusion versus without background infusion. Journal of Pain, 8 (12), 970–975. Van der Vyvewr, M., Halpern, S., & Joseph, G. (2002). Patient controlled epidural analgesia versus continuous infusion for labour analgesia: A meta-analysis. British Journal of Anesthesia, 89 (3), 459–465. Wong, C. (2010). Obstetric pain. In S. Fishman, J. Ballantyne, & J. Rathmell (Eds.), Bonica's management of pain (pp. 791–805). Philadelphia, PA: Lippincott Williams & Wilkins.

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SECTION IV: SPECIAL TREATMENT CONSIDERATIONS

11 Effect of Opioid Polymorphisms

Why do some women have more pain in the early stages of labor? It could be that they have a homozygous single-nucleotide polymorphism (SNP) at the GCH1 gene that makes certain women more sensitive to pain as the cervix dilates in early labor. Why do some women suffer more from headaches? It may be that they have a polymorphism at the A118 gene associated with opioid receptors. These differences in response to both pain and medication are associated with SNPs. An SNP in exon 1 of the mu-opioid receptor gene (OPRM1) has been associated with elevated pain responses and decreased pain thresholds in a variety of populations. In addition, OPRM1 is considered to be one of the prime candidates for genetic effect for the efficacy of opioids (Kolesnikov, Gabovits, Levin, Vioka, & Veske, 2011). This new area of research is uncovering new information about why some patients experience severe pain while others only minor pain with the same pain syndrome or surgery. This research also begins to explain why some medications work better for patients and not for others. Once this area has been expanded and it becomes more clinically relevant, we should see great strides in individualized pain management. Looking past just a single action, the combined effect of polymorphism at the OPRM1-A118G and catechol-O-methyltransferase (COMT) genotypes can affect pain relief. In a study with 200 abdominal surgical patients who had been screened using DNA from blood samples, the heterozygous patients with both the OPRM1 and COMT mutation consumed much less morphine via patient-controlled analgesia than the homozygous patient group. The decreased morphine consumption continued into a 48-hour period postoperatively, and this group had fewer side effects such as nausea and sedation (Kolesnikov et al., 2011). In a second study, 79 orthopedic trauma patients were screened for the OPRM1 and COMT genotypes. Patients who screened positive for AG and GG genotypes of A118G allele demonstrated lower sedation scores than the AA genotype, giving preliminary evidence that the G allele may contribute in some 167

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168 11. Effect of Opioid Polymorphisms way to a decreased sedative effect in the immediate postoperative time period. Additionally, the study identified a COMT haplotype GCGG with a 12.1% frequency, where these individuals had higher pain scores, used more opioids, and had higher heart rates than those patients without the genetic variation (Henker et al., 2012). Opioids have long been considered the mainstay for treating pain as part of a multimodal approach to pain management (American Pain Society [APS], 2005; Droney & Riley, 2009; Hanks & Reid, 2005; Mercadante & Bruera, 2006; Slatkin, 2009; Vadalouca, Moka, Argyra, Sikioti, & Sifaka, 2008; World Health Organization [WHO], 1996). Most opioids are processed through the CYP pathways in the liver. However, not all patients respond to the opioids prescribed for treating their pain in the same way. One reason for the variation is patient metabolism. In a study with 10 healthy volunteers, oral oxycodone was given after inhibition of the CYP2D6 metabolic pathway with quinidine or CYP3A metabolic pathway with ketoconazole. A cold pressor test was performed to produce a pain stimulus. The oxycodone-quinidine group had a decreased peak effect for medication (Samer et al., 2010). In the oxycodone-ketoconazole group, a dramatic increase in medication efficacy and in oxycodone toxicity was observed (Samer et al., 2010). Since the two CYP pathways are used to transform opioids, knowing what happens when they are altered or inhibited can explain some of the differences in medication response and offer information that is useful for avoiding polypharmacy that affects analgesia. All opioids bind to an area of the cell called the mu receptor, found in many areas of the body such as peripheral nerves, pre- and post-synaptic neural junctions, and even in the colon, which is considered to be the major mechanism for opioid-induced constipation (Inturrisi & Lipman, & 2010). Recent research has shown that there may be as many as 45 or more different variations in the makeup and action of the mu receptor sites (Pasternak, 2005) and many more variations in the proteins required to allow cellular binding of the opioid to the receptor site (Pasternak, 2010). We know that individual variations such neuronal plasticity and wind-up, gender, metabolism rates, race, and familial tendencies also affect the way the patient responds to both pain stimulus and opioid medication (APS, 2005; D’Arcy, 2011b; Fillingim, 2010). For many years the use of morphine was considered to be the best and most effective method for treating patients who were having significant pain. Today we know that there are any number of opioid and nonopioid combinations that are effective for pain relief, and many different types of interventions such as regional anesthesia that can help provide analgesia for patients with cancer pain. The current trend reflects the need to tailor pain management strategies to each individual and utilize those treatment

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options that provide the best level of relief for the patient. For example, using agonist–antagonist medications can potentially produce greater pain relief in women than men. What we also have come to understand is the large number of individual factors that can affect the speed at which the patient metabolizes opioids and the way the patient is genetically programmed to utilize opioids. For years, clinicians noted that not all patients with certain procedures such as abdominal surgery responded in the same way to pain medications, even though the surgical procedure was the same. In the past, nurses might tell patients, “Most people with this surgery are out of bed by day 2,” while patients with poor pain control or significant adverse effects were still in bed hoping to stay there all day. Today we look at the patient as an individual who brings a large number of factors to the pain management process. Hopefully, the choices we make for controlling pain produce an optimal outcome. Phamacogenomics is the study of variations in the human genome and how these variations affect the response to drugs (Janetto & Bratanow, 2011). Factors that can affect the way the patient responds to a given drug are: ■ Age ■ Sex ■ Race ■ Comorbidities ■ Drug–drug interactions ■ Hepatic/renal function ■ Genetics, especially the differences in disposition and metabolism of the drugs (Fillingim, 2010; Jannetto & Bratanow, 2011) Today we know these variations in response could be caused by a reflection of the individual patient’s genetic configuration for a particular opioid to provide pain relief. Rapid metabolizers of opioids have a very different response to opioids when compared to the ultra-slow metabolizers. For the first type of patient, there may not be enough opioid prescribed to control the pain, pain intensity ratings will continue to be high, and the patient may continue to ask for more medication when all prescribed doses have been given. The ultra-slow opioid metabolizers may need only very small amounts of medication to achieve adequate pain control, while the medication that is given can remain in the patient’s system for longer than other patients. These patients may not know that they are not the same genetically, but both types of patients know that pain relief for them is difficult. Nurses are not aware of how any individual patient metabolizes medication or if the patient cannot respond to certain opioids. This makes finding the right combination of medications and doses for any individual patient a challenge.

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170 11. Effect of Opioid Polymorphisms Taking the example of patients undergoing cancer treatments, many of whom are affected by genetic differences. In some breast cancer patients, the cancer is estrogen-sensitive or genetically specific. This in turn determines what type of chemotherapy is most effective for treating the cancer. Genetically engineered viruses that express specific neurotrophins are being studied to see if they can control neuropathic pain, while specially coded herpes simplex virus is being studied as a means of controlling metastatic bone pain, inflammatory pain, and neuropathic pain in animal models (Thapa, Rastogi, & Ahuja, 2011). We are beginning to understand that genetics plays a big role in how medications for pain work in patients and how to determine what those differences mean clinically. This chapter discusses the sources of opioid polymorphisms. It will cover the topics of opioid rotation or switching, effects of metabolism on opioid activity, the role of the mu receptor, and the occurrence of opioid hyperalgesia. In order to fully understand how to rotate opioids for best effect, the concept of equianalgesia will also be reviewed.

THE ROLE OF THE MU RECEPTOR Opioids in general bind to a section of the cellular membrane called the mu receptor site. The opioid molecule locates the opioid receptor site and binds with the site, creating an analgesic effect (see Figure 11.1).

nerve terminals

morphine opiate receptors

cell membrane

Figure 11.1 ■ Opioid-binding mechanism.

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In the past, the opioid binding mechanism was considered to be a lock-and-key effect, but now we know the action is highly complex and dependent on a large number of factors such as sex, genetics, protein type, and metabolism rate. These differences are considered to be important factors, and when applied to mu activity are called opioid polymorphisms. There are three major types of binding sites for pain medications: Mu —the primary binding site for pure mu opioid agonists, such as morphine, hydromorphone, and fentanyl. The mu receptor is responsible for not only analgesia but several other related effects such as respiratory depression and tolerance. Kappa —a secondary binding site for mixed agonist–antagonist medications such as nalbuphine, and buporenorphine. The medications bind as agonists at the kappa site and antagonists at the mu site, and since they are located lower on the spinal cord they have less potential for respiratory depression. Delta —a less-known binding site with action that has not been fully explored (Gourlay, 2005; Inturrisi & Lipman, 2010). The mu receptor sites are located throughout the body, including in many areas of the brain, in the periphery, and on some circulating immune cells (Shi, Cleeland, Klepstad, Miaskowski, & Pedersen, 2010). Receptor genes that are associated with these receptor sites include the mu receptor gene MOR-1, a delta receptor site called DOR-1, and a kappa receptor site called KOR-1 (Gourlay, 2005). Of particular interest is that these receptor sites may be expressed in overlapping configurations, making it difficult to determine the most effective binding potential. Currently there are thought to be as many as 100 polymorphisms of the OPRM1 gene, a mu receptor gene (Nagashima et al., 2007). There are three findings that are salient when considering the effect of genetic polymorphisms of pain. ■ Nearly all naturally occurring (endogenous) and manufactured opioids bind to the high-affinity, naloxone-sensitive mu1 receptor with similar affinity as the source of analgesia. ■ Agonist-binding affinities create the analgesic response. ■ Splice variants called heterodynes or homodimers are thought to be responsible for analgesic response (Gourlay, 2005; Evans et al., 2010). As our knowledge of the genetic effects on opioid binding and affinity expands, new information on gene splice variants has provided additional insight on the topic. Some of these variants like the MOR/KOR heterodimers are affected by estrogen levels and are only seen in females (Chakbarati, Liu, & Gintzler, 2010). Splice variants can occur at either end of the gene, causing wider variation in the make-up of the binding sites, affecting the dose requirement of opioids for pain control.

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172 11. Effect of Opioid Polymorphisms Clinical Pearl

W hy do we need pain? Pain can serve a protec ve func on. In a rare occurrence in nature there is one gene c varia on that does not allow the person to experience pain, referred to as congenital insensiƟvity to pain. These non-sense muta ons in genes are rarely expressed, but when they do occur it can be very serious for the person with the condi on, causing p ainless injuries, chronic skin ulcers, and distal amputa ons (Miaskowski, 2009; Trembaly & Hamet, 2010).

The genetic profile for a patient is as individual as a fingerprint, or iris pattern. Genetically, there are innumerable gene combinations that can produce any one human being. For opioids, the gene that encodes for morphine activity, called mu-opioid receptor gene (OPRM1, is the key to the response of patients to the mu agonist morphine. The COMT gene is also a highly likely candidate for influencing the efficacy and side effects of morphine in patients with cancer (Shi et al., 2010). The combined action of these two genes can affect the ability of morphine to control pain, morphine consumption, and produce side effects. In a study of 207 hospital inpatients who had been using morphine for pain control for at least 3 days, carriers of the Met/Met and AA genotype in the OPRM1 and COMT gene needed less morphine for pain relief (Reyes-Gibby et al., 2007). More specifically, carriers of the OPRM1 GG genotypes needed 93% higher morphine doses when compared to the AA variant of the genotype. For the COMT genotypes, the Val/Val and Val/Met genotypes required 63% and 23% higher morphine doses, respectively, when compared to the Met/Met genotype of the COMT gene (Reyes et al., 2007). Although this seems complicated the take away message is that genetic variations such as different genotypes of even the same gene can create differences in pain relief and opioid consumption.

SEX, GENDER, AND RACE As research has expanded into the area of differences in response to pain and pain medications, the idea of differences in sex, gender, and race have become integral issues to explore. In a review of animal research studies from 1996 to 2005, 79% of the studies used only male subjects in their research (Mogil & Max, 2009). Even in early studies of breast cancer research, the early studies were conducted using only male participants. At that point women were felt to be emotional responders to pain and the effect of estrogen was poorly understood, causing researchers to just eliminate them from studies to avoid trying to control for the variables. In the mid-1990s, publications started appearing in reputable journals that highlighted the need to study the pain response of women and

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determine if there were a difference that made women’s pain a unique experience for them. At the same time, the National Institutes of Health (NIH) developed several initiatives on pain in women that generated significant interest in the topic. After this initiative, researchers began to explore the various areas of pain in women and tried to determine if there was an overall difference in pain in women or if there was only a difference in some of the pain syndromes that were more common in women than men, such as fibromyalgia and osteoarthritis pain. Do men and women experience pain differently? Yes, they do, as a result of their hormonal variation and differences in pain pathway activation when a pain stimulus is presented for interpretation. Are there differences in the way that men and women respond to pain medications? Again the answer is yes, for a variety of reasons. Some of these differences include: ■ Specific, different pain pathways for men and women ■ Differences in the way pain is processed ■ Effect of sex hormones ■ Differences in response to opioid medications ■ Lower threshold and tolerance for pain (Wilson, 2006) There are some pain syndromes that are more specific to women than men. Examples of these syndromes include: ■ Fibromyalgia ■ Temporomandibular (TMJ) pain ■ Phantom breast pain ■ Postmastectomy pain syndrome ■ Menstrual-related migraine ■ Irritable bowel syndrome ■ Interstitial cystitis ■ Vulvodynia In a study to compare the analgesic effect of morphine in both men and women, three important conclusions were derived: ■ Morphine is more potent in women than men ■ The onset and offset of morphine is slower in women than men, making it seem that the medication is less effective ■ Plasma concentrations of both the active drug and two metabolites were identical for both sexes (Dahan, Kest, Waxman, & Sarton, 2008) These findings are particularly important for acute pain and postoperative pain management. Since morphine is considered the gold standard for pain management medication comparison and commonly used in postoperative pain relief, these differences in potency and onset are important considerations when pain relief is assessed. As an interesting addendum, the sex effect with morphine disappears with older patients, leading to

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174 11. Effect of Opioid Polymorphisms the speculation that hormones have an effect on morphine’s ability to pass through the blood–brain barrier (Dahan et al., 2008). In addition to the differences in morphine with men and women, the side effects from opioid medications tend to have some sex-related relationships. The most common are nausea and vomiting, sedation, cardiovascular effects, and respiratory depression. These differences include: ■ More nausea and vomiting with women using opioids for postoperative pain control ■ Increased risk for opioid-induced respiratory depression in women ■ Morphine is associated with lower heart rate in women but the development of hypertension in men ■ With opioid use, women reported more feelings of euphoria (a high feeling) and reported more instances of dry mouth (Dahan et al., 2008) Other differences with pain medications were related to differences seen with kappa agonist medications such as nalbuphine, butorphanol, and pentazocine. The melanocortin-1 (Mc1r) receptor gene has a specific role in modulating a pain pathway that exists only in women. This gene is commonly associated with people who have red hair, fair skin, freckles, and a high predisposition to melanoma (Dahan et al., 2008). The key elements to this finding include: ■ Tested by giving pentazocine to both men and women ■ Pain relief in redheaded, fair-skinned women, but no pain relief in men ■ Hypothesis is that men and women have separate pain pathways that are created by different genes and neurochemicals (Mogil, 2006) The study of differences in pain response physiologically by men and women is a very new area of research. Much more research is needed to confirm these early findings. The early research is promising and points the way to finding the true differences between men and women in both pain response and medication efficacy.

THE GENETIC EFFECT Variations in genetics have been identified that affect the major mechanisms of medication management. These variations in medication use affect medication: ■ Absorption ■ Distribution ■ Metabolism ■ Elimination (Janetto & Bratanow, 2011) The genetic effect on pain relief is becoming an area of great interest in pain management practices. Since each patient comes to us as a genetic unknown, we need to look at the research to determine what pieces of

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175

Neuronal Plasticity, Wind-Up, Allodynia, Opioid Hyperalgesia, and Other Factors

information we can use to help maximize pain relief. Research in this area is by no means complete, but there are some studies that illustrate how genetics affects pain relief. Studying the SNP of the MOR gene, responsible for OPRM1 activity, has provided some interesting findings. In a study of 74 patients who were having total knee replacements, genetic profiling revealed three separate groups of patients. To determine how much medication provided pain relief for each group, morphine PCA was used for postoperative pain management. Analgesia reports and opioid consumption were tracked for 48 hours postsurgery: ■ AA-homozygous patients with an efficient morphine metabolism – this group used 25 mg of morphine and had good pain relief ■ AG-heterozygous variant patients used 25 mg of morphine and had good pain relief ■ GG-homozygous nonsensitive genetic variant patients with reduced or impaired morphine sensitivity had very different results. They used 40 mg of morphine and had many more attempts on the PCA, trying to get a better level of pain control (Chou et al., 2006). Specifically for pain in cancer patients, research has identified eight SNPs that were significantly involved in opioid therapy outcomes for at least 570 patients (Galvan, Skorpen, et al., 2011). Inflammatory markers were also identified in lung cancer patients where CC genotypes were at lower risk for severe pain, while NFKBIA, a specific genetic substance, was identified as allowing for severe pain (Reyes-Gibby et al., 2009). As far as ethnic origins, a study examining ethnicity and pain in 2,294 patients with cancer found four genetic profiles that spanned country of origin and affected pain relief (Galvan, Fladvad, et al., 2011). As research in these areas develops, more information will be available to determine just what type of patient response can be expected with specific genotypes and how the role of genetics affects pain management outcomes in patients with cancer.

NEURONAL PLASTICITY, WINDUP, ALLODYNIA, OPIOID HYPERALGESIA, AND OTHER FACTORS One factor that has an obvious effect on opioids is the rate of medication metabolism. Patients are now classed as ultra-rapid or rapid metabolizers, down through moderate metabolizers to ultra-slow medication metabolizers. For the clinician, the ultra-rapid or rapid metabolizer just eats up the medication and continues to complain of pain well before the next dose of medication is due. There is currently a black box warning on the use of acetaminophen and codeine with breastfeeding mothers for rapid medication

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176 11. Effect of Opioid Polymorphisms metabolizers since the active metabolite, morphine, was being passed to the infants through breast milk (D’Arcy, 2011a). The ultra-slow metabolizer needs just a small amount of medication and may become oversedated or have side effects such as nausea. These patients may report that they are sensitive to opioids or that many opioids tend to make them nauseated. Both of these types of patients, rapid or slow metabolizers, will report difficulty with pain medications. Listening to the patients explain their past experience will provide insight into the complexities of managing pain in these individuals. Drug–drug interaction can also affect the quality of pain relief for the patients with pain. Since most medications are activated in the liver through the CYP450 system, any drug that inactivates or potentiates opioids can affect the quality of pain relief.

PLASTICITY When pain becomes a chronic condition, as with many patients with fibromyalgia or interstitial cystitis (IC), for example, the repeated pain stimulus can cause changes in the patient’s body and the way it responds to and processes the pain. With repeated pain stimuli, the body changes its function to respond more globally and the neurons have the ability to change function, called neuronal plasticity. Pain-facilitating substances such as Substance P and other cytokines are recruited at the site of the pain, creating a heightened sensation of pain over a larger area, resulting in inflammation. Peripheral sensitization is the result with resultant hyperalgesia and/or allodynia. Long-term use of high-dose opioids is implicated in the creation of a specific hyperalgesic condition called opioid-induced hyperalgesia. The treatment for this condition is ■ Opioid rotation ■ Dose reduction of opioids, which requires the implementation of alternate sources of pain relief Clinical Pearl

Hyperalgesia – a heightened response to a normally mild pain such as a pinprick. Allodynia – a pain response when the sensa on is normally not painful, such as being stroked with a wisp of co on or c o on swab.

With prolonged pain from the periphery, the central nervous system changes its processing of the pain signals, causing increased pain intensity and pain duration. This phenomenon is called wind-up. Once the pain

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is activated by the central nervous system receptors, called N-methyl-daspartate (NMDA), further intensification and progression of the pain results. The whole process becomes a vicious cycle and is much more difficult to treat. Examples of conditions where this type of pain is found are osteoarthritis and complex regional pain syndrome (CRPS).

EQUIANALGESIA AND OPIOID ROTATION Equianalgesia is the conversion of one opioid to the equivalent analgesic dose of another opioid, based on equivalency charts. These equianalgesic charts are designed to provide guidance for practitioners who are prescribing or treating patients on opioid therapy. Although it seems like a simple process to take one medication, look to see what an equivalent dose is, and then start the new medication, there are pitfalls and risks that make the process challenging. One of the major pitfalls for the use of equianalgesic tables is that they are based on the potency of the medication. Potency is defined as the dose required to produce a given effect (Knotcova, Fine, & Portnoy, 2009). Potency can vary from one individual to another and from one medication to the next. There are outside factors that can influence how potent a medication is for the patient, which can skew the results of a comparison. Equianalgesic tables are based on single-dose trials in healthy volunteers (usually young adult males). The ways that equianalgesic doses have been determined in the past are expert opinion, single-dose studies, and studies in noncancer patients (Shaheen, Walsh, Lasheen, Davis, & Lagman, 2009). This makes using these tables an estimation only when the prescriber feels they need to do the closest possible conversion. The best use of equianalgesic tables is to use the doses as a guide rather than an absolute. In a study comparing equianalgesic tables, findings indicate that in some tables the conversion for oral morphine to parenteral ranged from 2:1 to 6:1, and ranges for oral to parenteral hydromorphone were from 2:1 to 5:1 (Shaheen et al., 2009). For the clinician, this lack of concrete applicability is problematic. Here is where the art and science of pain management meet. The science of pain management provides the structure for an equianalgesic conversion while the art allows the clinician to interpret the best dose for the patient. Knowing the patient is an important part of a successful conversion. Allowing for additional breakthrough medication can also provide for adequate pain relief if the conversion falls a bit short of what is needed to maintain sufficient pain relief.

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178 11. Effect of Opioid Polymorphisms Clinical Pearl

Equianalgesia is defi ned as the dose at which two opioids provide approximately the same pain relief. The gold standard is 10 mg of parenteral morphine (Shaheen et al., 2009).

There are many sources for equianalgesic conversion tables. Exhibit 11.1 provides one example. Other sources that can be accessed include: ■ American Pain Society. (2008). Principles of analgesic use in the treatment of acute pain and cancer pain. Retrieved from www.ampainsoc.org ■ Online opioid analgesic converter available at www.globalrph.com/ narcoticcanv.htm ■ Dosing equivalencies from the Physicians’ Desk Reference ■ Prescribing information from package inserts There are pros and cons to using any equianalgesic table. One of the biggest pros is that it simplifies the mathematical conversion from one medication to another. The list is usually a conversion of the most commonly used medications. The cons, however, are still very significant and include: ■ Failure to standardize a reference opioid ■ Many tables are the product of a single-dose conversion in a laboratory setting with volunteers using artificially produced acute pain ■ The table presents a wide range of doses ■ Equianalgesia is compared with short- and long-acting medications, and not at steady state; therefore, the necessary dose may be lower than estimated ■ Use of computations instead of a clinical trial to determine equianalgesic doses (Shaheen et al., 2009) Opioid rotation is needed for about 40% of patients with advancedstage cancer and can also be used for patients with chronic pain (Shaheen et al., 2009). For those patients who do require an opioid switch, about 70% to 80% have an improvement in the balance between analgesia and adverse effects (Mercadante & Bruera, 2006). The rationale for using an opioid rotation is to increase the pain relief being provided by the patient and/or lessen intolerable side effects such as nausea. Patients are candidates for opioid rotation if they experience any of the following: ■ Decreased efficacy of opioids ■ Do not have improved analgesia with increased doses ■ Develop intolerable side effects but still have significant pain A Cochrane review of the literature on opioid rotation reports that the evidence for opioid switching is largely anecdotal or based on lower-level studies (Quigley, 2010). However, the practice is established in the cancer pain population where high-dose opioids are used routinely to control pain. For patients with chronic pain, opioid switching offers an option for improved pain relief, increased opioid response, and decreased unwanted

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side effects. In a review of the literature on opioid switching, Mercadante and Bruera (2006) reported that clinical improvement is seen in approximately 50% of patients with chronic pain who have a poor response to a specific opioid. Providing the patient with an opioid rotation may improve the pain control and decrease fears of having pain that cannot be controlled. To perform an opioid rotation, the clinician first reviews an equianalgesic chart to determine equivalencies. Then the clinician needs to evaluate ■ The level of pain ■ The effect of the adverse effects ■ Any comorbidities that affect medication choice (such as renal or hepatic impairment) ■ Concomitant medications Extreme care must be used when converting patients from high-dose opioids to another medication to avoid over- or underdosing the patient and preserving patient safety throughout the process. Data on conversions from morphine to hydromorphone or hydrocodone is more available and the result is more predictable. Converting patients from long-acting medications such as methadone to a short-acting, fastonset medication such as fentanyl or even a standard conversion for morphine

Clinical Pearl

Opioid rotaƟon is defi ned as a therapeu c maneuver aimed at increasing analgesia while decreasing opioid side eff ects. It is defi ned as a change in opioid drug or route of administra on with the goal of improving outcomes (Fine & Portnoy, 2009). This includes changing medica ons using the same route or maintaining the current medica on but changing the route of administra on, or both (Knotkova et al., 2009; Vadalouca et al., 2008).

requires a careful and measured response. Data for the success of such conversions are scant and using a pharmacist for assistance should be considered. Issues that should be considered when performing an opioid rotation in order to avoid an error include: ■ Knowledge of opioid pharmacology ■ Awareness of the limitation of equianalgesic tables ■ Application of the conversion/rotation guidelines ■ Tailoring opioid doses to the individual patients and monitoring the response (Shaheen et al., 2009) Because the patient may be more responsive to the new opioid dose, there are some considerations that should be used before completing the con-

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180 11. Effect of Opioid Polymorphisms version. Before implementing an opioid rotation, best practice guidelines recommend the following: ■ Use an equianalgesic table to calculate the new opioid dose ■ For most opioids other than fentanyl or methadone, use an automatic dose reduction of 25% to 50%. If methadone is the new opioid, reduce the dose by 75% to 90% ■ Use caution with high-dose conversions (greater than 1,000 mg morphine equivalents); expert consultation is recommended. These conversions may require inpatient monitoring, including serial electrocardiograms ■ Select a dose in the 50% reduction range if the patient is on high-dose opioids, is not Caucasian, or if the patient is elderly or frail ■ Select a dose in the 25% reduction range if the patient is on a low to moderate dose of opioids, is Caucasian, under age 60, and reasonably robust, or if the change is from one route to another with the same medication ■ Assess the patient for the severity of the pain or other medical characteristics that would point to a need for higher or lower doses, and increase or decrease the dose by an additional 15% to 30% to increase the chances that the converted dose will be effective or to avoid withdrawal ■ Maintain a schedule of frequent reassessment and monitoring and titrate the dose to maximize outcomes ■ Provide adequate rescue or breakthrough pain doses for titration at 5% to 15% of the total opioid dose (Fine & Portnoy, 2009) Knowing the patient well and understanding how she has reacted to opioid medications in the past is part of a comprehensive evaluation to performing an opioid rotation. Since there is the potential for opioid cross tolerance, a conservative approach and the use of frequent breakthrough medication can help reduce the risk during the period of rotation. Monitoring the effect of the new medication is essential. An example of a simple opioid rotation is provided in the following. Clinical Pearl

Example of an opioid rota on conversion: MS Con n to O xycon n Original Medica on: MS Con n Dose: MS Con n 120 mg twice per day with MSIR 30 mg every 4 hours as needed for pain (using an average of 4 tablets per day = 120 mg/day) New Medica on: Oxycon n Equianalgesic conversion: MS Con n 120 mg twice per day (240 mg/day) is equal to oxycon n 80 mg twice per day (160 mg/day).

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Clinical Pearl

181

MSIR 30 mg is equal to oxycodone 20 mg every 4 hours. Decrease the new dose by 25% to 50% 25% = Oxycon n 60 mg twice per day with 15 mg of oxycodone every 4 hours for breakthrough pain 50% = Oxycon n 40 mg twice per day with 10 mg of oxycodone every 4 hours for breakthrough pain Source: D’Arcy, 2011a.

For patients who need opioid rotation, converting from one problematic opioid to one that is more successful can provide patients with the cancer pain relief they need. Case Study Rebecca is an oncology patient who has just undergone extensive abdominal surgery for colon cancer. She has been taking Oxycontin 20 mg twice per day plus Vicodin for breakthrough pain for about 6 months. It was barely enough to cover her abdominal pain, but her health care provider did not want to increase her dose for fear that a small bowel obstruction might occur. Following surgery, it seems difficult to provide Rebecca adequate pain control. She is given a morphine PCA set at 1 mg every 10 minutes, and has pushed the button 60 times while only getting 6 doses of medication in the last hour. She is beginning to feel that the PCA is not working. Rebecca reports that she is getting more and more nauseated and she feels like it is not worthwhile to push the button on her PCA. She shares that she would almost rather experience the pain than the nausea.

Questions to Consider 1. What effect is Rebecca’s unrelieved preoperative pain having on her postoperative pain? 2. Looking at the way Rebecca’s PCA is set, does she have enough pain medication ordered to match her preoperative oral medications and her new surgical pain? Check the equianalgesic chart for a conversion. 3. Is the choice of morphine the best one for Rebecca? What might be better? Would you expect the nausea for Rebecca? 4. Would an opioid rotation be needed for Rebecca to improve her pain control?

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182

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Generic 30 milligrams

Oral Dose

Vicodin, Lortab Sublimaze Dolophine

Demerol

Hydrocodone

Fentanyl

Methadone

Meperidine

NR

5–10 milligrams

NA

30 milligrams

Opana, Numorphan 10 milligrams

Oxymorphone

7.5 milligrams

Roxicodone, Oxy IR 20 milligrams

Roxanol, MSIR

Brand Name

Hydromorphone Dilaudid

Oxycodone

Immediate release Morphine

Analgesics

Exhibit 11.1 Equianalgesic Table for Opioid Conversion

NR

10 milligrams

100 micrograms

NA

1 milligram

1.5 milligrams

NA

10 milligrams

Parenteral

(continued)

Use with caution. Toxic metabolite normeperidine can cause seizures

Use with caution: Halflife of 12–150 hours accumulates with repeated dosing

Extended half-life with short-acting oral form

Relative potency 1:6 with acute dosing and 1:2 to 1:3 with chronic dosing

183

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Generic

Duragesic

Oxycontin

Kadian

MSContin, Avinza,

Brand Name

NA

20–30 milligrams

20–30

Oral Dose

25 micrograms

Parenteral

Basic intravenous conversion: Morphine 1 milligram 5 Dilaudid 0.2 milligrams 5 Fentanyl 10 micrograms. NR 5 not recommended. When switching from one opioid to another, reduce the dose by 25% to 50% with adequate breakthrough medication. When switching to methadone, reduce the equianalgesic dose by 75% to 90%. Breakthrough medication should be available when controlled-release medications are being used. All opioid medications should be carefully dosed and titrated with consideration for the individual patient and the medical condition of the patient. Sources: American Pain Society. (2008). Principles of analgesic use in the treatment of acute pain and cancer pain; Fine, P., & Portnoy, R. (2007). Opioid analgesia; Inturrisi, C., & Lipman, A. (2010). Bonica’s management of pain, pp. 1174–1175; Smith, H., & McCleane, G. (2009). Current therapy in pain. Used with permission of the author.

Fentanyl transdermal

Not recommended Morphine for opioid-naïve patients Oxycodone

Controlled Release

Exhibit 11.1 continued

184 11. Effect of Opioid Polymorphisms

REFERENCES American Pain Society. (2005). Guideline for the management of cancer pain in adults and children. Glenview, IL: Author. Chakrabati, S., Liu, N., & Gintzler, A. (2010). Formation of mu-/k-opioid receptor heterodimer is sex-dependent and medicates female-specific opioid analgesia. Proceedings of the National Academy of Sciences, 107(46), 20115–20119. Chou, W. Y., Yang, L. C., Lu, H. F., Ko, J. Y., Wang, C. H., Lin, S. H., & Hsu, C. J. (2006). Association of mu-opioid receptor gene polymorphism (A118G) with variation in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiologica Scandinavica, 50 (7), 787–792. Dahan, A., Kest, B., Waxman, A., & Sarton, E. (2008). Sex-specific response to opiates: Animal and human studies. Anesthesia & Analgesia, 107(1), 83–95. D’Arcy, Y. (2011a). Compact clinical guide to chronic pain management. New York, NY: Springer. D’Arcy, Y. (2011b). Women’s pain management issues. Pain Management Nursing, 12 (1), S1–S3. Droney, J., & Riley, J. (2009). Recent advances in the use of opioids for cancer. Journal of Pain Research, 2, 135–155. Evans, R., You, H., Hameed, S., Altier, C., Mezghrani, A., Bourinet, E., & Zamponi, G. (2010). Heterodimerization of the ORL1 and opioid receptors and its consequences for N-calcium channel regulation. Journal of Biological Chemistry, 285(2), 1021–1040. Fillingim, R. (2010). Individual differences in pain: The roles of genetics, ethnicity, and genetics. In Bonica’s management of pain (pp. 86–98). Philadelphia, PA: Lippincott Williams & Wilkins. Fine, P., & Portnoy, R. (2009). Establishing “best practices” for opioid rotation: Conclusions of an expert panel. Journal of Pain & Symptom Management, 38 (3), 418–425. Galvan, A., Fladvad, T., Skorpen, F., Gao, X., Klepstad, P., Kaasa, S., & Dragani, T. (2011). Genetic clustering of European cancer patients indicates that opioid-mediated pain relief is independent of ancestry. Pharmacogenomics Journal, 5, 412–416. Galvan, A., Skorpen, F., Klepstad, P., Knudsen, A., Fladvad, T., Falvella, F., . . . Dragani, T. (2011). Multiple loci modulate opioid therapy response for cancer pain. Clinical Cancer Research, 17, 4581–4587. Gourlay, G. (2005). Advances in opioid therapy. Supportive Care in Cancer, 13, 153–159. Hanks, G., & Reid, C. (2005). Contributions to the variability in response to opioids. Supportive Care in Cancer, 13, 145–152. Henker, R., Lewis, A., Dai, F., Lariviere, W., Meng, L., Gruen, G., . . . Conley, Y. (2012). The associations between OPRM1 and COMT genotypes and postoperative pain, opioid use, and opioid induced sedation. Biological Research for Nursing, June 20, 2012. DOI 10.1177/1099800411436171. Inturissi, C., & Lipman, A. (2010). Opioid analgesicis. In Bonica’s management of pain (p. 1172). Philadelphia, PA: Lippincott Williams & Wilkins. Inturissi, C., & Lipman, A. (2010). Opioid analgesics. In Bonica’s management of pain (pp. 1172–1181). Philadelphia, PA: Lippincott Williams & Wilkins. Jannetto, P., & Bratanow, N. (2011). Pain management in the 21st century; utilization of pharmacogenomics and therapeutic drug monitoring. Expert Opinion Drug Metabolism Toxicology, 7(6), 745–752.

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Knotkova, H., Fine, P., & Portnoy, R. (2009). Opioid rotation: The science and limitations of the equianalgesic dose table. Journal of Pain & Symptom Management, 38 (3), 426–439. Kolesnikov, Y., Gabovits, B., Levin, A., Vioko, E., & Veske, A. (2011). Combined catechol-O-methyltransferase and mu-opioid receptor gene polymorphisms affect morphine postoperative analgesia and central side effects. Anesthesia & Analgesia , 112, 448–453. Mercadante, S., & Bruera, E. (2006). Opioid switching: A systematic and critical review. Cancer Treatment Reviews, 31, 304–315. Mercadante, S., Gebbia, V., David, F., Aielli, F., Verna, L., Casuccia, A., . . . Ferrera, P. (2009). Tools for identifying cancer pain of predominantly neuropathic origin and opioid responsiveness in cancer patients. Journal of Pain, 10 (6), 594–600. Miaskowski, C. (2009). Understanding the genetic determinants of pain and pain management. Seminars in Oncology Nursing, 25(2, Suppl. 1), S1–S7. Mogil, G., & Max, M. (2006). The genetics of pain. In S. B. McMahon & M. Koltzenburg (Eds.), Wall & Melzack’s textbook of pain (5th ed., pp. 159–174). Philadelphia, PA: Elsevier/Churchill Livingstone. Mogil, J. S. (2009). Animal models of pain: Progress and challenges. Nature Reviews Neuroscience, 10(4), 283–294. Nagashima, M., Katoh, R., Sato, Y., Tagami, M., Kasai, S., & Ikeda, K. (2007). Is there genetic polymorphism evidence for individual sensitivity to opiates? Current Pain and Headache Reports, 11(2), 115–123. Pasternak, G. (2005). Molecular biology of opioid analgesia. Journal of Pain & Symptom Management, 29 (Suppl. 5), S2–S9. Pasternak, G. (2010). Molecular insights into μ opioid pharmacology. Clinical Journal of Pain, 26(1), S3–S9. Quigley, C. (2010). Opioid switching to improve pain relief and drug tolerability. The Cochrane Collaboration in The Cochrane Library, (11), CD004847. Reyes-Gibby, C., Shete, S., Rakvig, T., Bhat, S., Skorpen, F., Bruera, E., . . . Klepsted, P. (2007). Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRMI and COMT gene. Pain, 130, 25–30. Reyes-Gibby, C., Spitz, M., Yennrajalingam, S., Swartz, M., Gu, J., Wu, X., . . . Shete, S. (2009). Role of inflammation gene polymorphisms on pain severity in lung cancer patients. Cancer Epidemiology Biomarkers & Prevention, 18 (10), 2636–2642. Samer, C., Daali, Y., Wagner, M., Hopfgartner, G., Eap, C., Rebsamen, M., . . . Desmeules, J. (2010). Genetic polymorphisms and drug interactions modulating CYP2D6 and CYP3A activities have a major effect on oxycodone analgesic efficacy and safety. British Journal of Pharmacology, 160, 919–930. Shaheen, P., Walsh, D., Lasheen, W., Davis, M., & Lagman, R. (2009). Opioid equianalgesic tables: Are they all equally dangerous? Journal of Pain & Symptom Management, 38 (3), 409–417. Shi, Q., Cleeland, C., Klepstad, P., Miaskowski, C., & Pedersen, N. (2010). Biological pathways and genetic variables involved in pain. Quality of Life Research, 19, 1407–1417. Slatkin, N. (2009). Opioid switching and rotation in primary care: Implementation and clinical utility. Current Medical Research and Opinions, 25(9), 2133–2150.

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186 11. Effect of Opioid Polymorphisms Thapa, D., Reastogi, V., & Ahuja, V. (2011). Cancer pain management—current status. Journal of Anesthesiology Clinical Pharmacology, 27(2), 162–168. Tremblay, J., & Hamet, P. (2010). Genetics of pain, opioids and opioid responsiveness. Metabolism Clinical and Experimental, 59 (Suppl. 1), S5–S8. Vadalouca, A., Moka, E., Argyra, E., Sikioti, P., & Siafaka, I. (2008). Opioid rotation in patients with cancer: A review of the current literature. Journal of Opioid Management, 4(4), 213–250. Wilson, J. F. (2006). The pain divide between men and women. Annals of Internal Medicine, 144(6), 461–464. World Health Organization. (1996). Cancer pain relief (2nd ed.). Geneva, Switzerland: Author.

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12 Differences in Opioid Addiction, Dependency, and Tolerance

Although it may seem odd to differentiate addiction, dependency, and tolerance between women and men, there are some major differences that can help lead health care providers to a more individualized plan of care. Although substance abuse overall is higher in men than women, there are some instances, such as alcohol in younger women and prescription medication abuse (opioids and psychotropics), where rates are trending higher for women than men (Cotto et al., 2010). The issue that is most significant for women is the prescribing of and abuse of prescription medications. This is particularly significant when these statistics for opioid use also include women of childbearing age. Some of the data on differences in gender-related substance abuse are skewed by the fact that a greater number of males are referred from federal incarceration programs, while women more often seek help from general providers and their data are lost to followup. The National Epidemiologic Survey on Alcohol and Related Conditions, with a 43,093 patient cohort, indicated that males were 2.2 times more likely than women to abuse drugs and 1.9 times more likely to experience drug dependency (Greenfield, Back, Lawson, & Brady, 2010). However, the data also suggest that women have a greater tendency to escalate the adverse effects of their substance abuse while abusing for shorter periods of time and using less alcohol or addictive substances. This finding of using less but having more negative impact has serious implications for patients and prescribers. Ovarian hormones can influence the behavioral effects of drugs (Greenfield et al., 2010). In the follicular phase of the menstrual cycle, when estradiol levels are high, women have a heightened response to stimulants, while in the luteal phase of their menstrual cycle, women have a less intense response. Additionally, comorbid mood disorders are more common in women than men. The prevalence of mood and anxiety disorders in women with substance abuse disorders were 29.7% and 26.2%, respectively 187

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188 12. Differences in Opioid Addiction, Dependency, and Tolerance (Greenfield et al., 2010). This means that women have more variation in their drug use and are more affected by psychiatric disorders. In specific drug-related data, issues for drug use in women include: ■ Women are particularly vulnerable to the reinforcing effects of stimulant drugs and to hormonal effects, with estrogen increasing the effect and progesterone decreasing the feeling of “high” ■ Women tend to have more serious mental illness as a comorbid condition ■ Women abuse more prescription opioids than men, with abuse more common among younger women ■ Women are prescribed more opioids than men and report that their first source of opioids was a prescription provided by a health care provider ■ Women use less heroin and tend to inject the drug less than men ■ Women tend to mix sedatives, opioids, and other drugs ■ Men are more likely to use marijuana than women Prescription misuse and abuse is growing by astronomical rates in the United States. The National Survey on Drug Use and Health, with 68,736 respondents, reports that 4.7 million individuals used prescription opioid medications nonmedically in the previous month, and 1.7 million individuals met the criteria for dependence or abuse (Back, Lawson, Singleton, & Brady, 2011; Substance Abuse and Mental Health Services Administration [SAMHSA], Office of Applied Studies, 2009). This high rate of drug use in women can lead to fatal consequences. In a recent Morbidity and Mortality Weekly Report(MMWR) it was reported that deaths from opioid pain relievers had increased 5 fold between 1999 and 2010 for women (Mack, Jones, Paulozzi, 2013). Additionally deaths among women for drug overdose were reported to total 15,323 deaths among women for a rate of 9.8 per 100,000 population (Mack et al., 2013). Who are these women and what causes them to move from using medications solely for pain relief to prescription drug abuse? Men are interested in the pleasurable aspects of nonmedical use of prescription drugs, while women more often use medications this way to deal with negative emotions (Back et al., 2011). As indicated previously, women also experience a telescoping effect, where the time from authorized use moves to abuse is shortened when compared to men. Women also engage in aberrant behavior more commonly than men, such as hoarding medications or using other types of medications such as sedatives to enhance the effect of prescription medications (Back et al., 2011). Polysubstance abuse and non-use of treatment options are common for both men and women (Back, Payne, Simpson, & Brady, 2010). In a clinical trial to determine gender differences in prescription opioid dependence, 653 opioid dependent patients (261 women) were screened using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for opioid dependence.

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Fear of Addiction

Clinical Pearl

189

T he DSM-IV is used to determine if the pa ent meets criteria for addic on and opioid dependence.

Additionally, the Beck Depression Inventory, Addiction Severity Index, and the Clinical Opioid Withdrawal Scale were used. Successful treatment outcomes were based on patients’ ability to stop using opioids and follow a plan of care that included urine screening. The findings of this study indicate that when trying to withdraw from opioid use, women had more cravings and more family and social impairment than men (McHugh et al., 2013). Gender differences were found in preferred medication, with men preferring long-acting oxycodone and women preferring hydrocodone (McHugh et al., 2013). In a study of 29,906 individuals who were assessed in national treatment centers, the researchers tried to determine if there were any genderspecific tendencies that would predispose women to abuse prescription opioids. The study findings indicate that positive correlates were: ■ Problem drinking ■ Age