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January-February 2007; Issue 7Palliative Opioids Do Not Hasten Death High Dose CR Oxycodone Safe For End-of-Life Care Ovarian Cancer Pain Management May Be Inadequate Weak Evidence on Opioids For Chronic Back Pain Biases May Exist in Providing ER Diagnostics For Chest Pain Shoe Insoles Reduce Pain and Stiffness in Knee Osteoarthritis IV Lidocaine Relieves Postop Pain, Shortens Hospital Stay Chronic Pain in U.S. Workers Increasing Zolmitriptan 5mg Nasal Spray Highly Rated By Migraineurs Trigeminal Neuralgia and Its Treatment Reviewed Radiopharmaceutical Sm-153 Relieves Metastatic Bone Pain EUROPAD Journal Available Free at Pain-Topics.org Recent Drug and Device Approvals and Announcements
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; Steven J. Tucker, MD. Posting Date: February 22, 2007. Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products.
Palliative Opioids Do Not Hasten DeathWith growing evidence of ineffective pain management in many patient populations, this study surveyed data from the National Hospice Outcomes Project (NHOP) to determine if opioid use hastens death in patients with advanced illness. The medical records of 725 patients from the 13 hospices in the NHOP prospective longitudinal study were analyzed. All patients had at least one change in opioid dosing before their death, and the time period from dosing change to death was the subject of analysis. In addition, subsamples compared patients who received standard opioid doses with those who received high-dose opioid therapy. Across the entire sample, the mean +/- SD number of days between the last change in opioid dosage and death was 12.46 +/- 23.11 (median 5 days, range 0-231 days). While multivariate models demonstrated that higher opioid dosing, a cancer diagnosis, unresponsiveness, and lower pain scores showed a significant association with shorter survival times, only relatively minor variations in survival time were explained by these factors. The investigators reported that several study factors, including the relatively long intervals between final dose change and death, led them to conclude that the opioid dose itself carried a very small risk of hastened death. Clinical Conclusions: Advanced illness involves many complex factors; however, the investigators believe these results demonstrate that the effective use of opioids in this population will not hasten death. Additionally, they stress that the undertreatment of pain is a greater concern in this population and the use of opioids will provide the patient with a higher level of comfort at life’s end; thereby, resulting in a better quality of care. Reference: Portenoy RK, Sibirceva U, Smout R, et al. Opioid use and survival at the end of life: a survey of a hospice population. J Pain Symptom Manage. 2006(Dec);32(6):532-540. < Back to Top > High Dose CR Oxycodone Safe For End-of-Life CareA retrospective study evaluated the safety and effectiveness of high-dose controlled-release oxycodone in end-of-life cancer pain management. Patient records from a medical center hospice were divided into 3 groups based on maximum daily controlled-release oxycodone (OxyContin®) doses. A total of 34 patients were classified as low-dose recipients (mean daily dose 19.4 +/- 1.4mg), 45 received moderate doses (mean 62.2 +/- 28.3mg), and 18 patients were treated with high doses (mean 231.1 +/- 74.9mg). Data evaluation showed that low level pain (less than 3 on a 10-point VAS scale) was reported by patients 97%, 95%, and 89% of the time in the low, moderate, and high dose groups, respectively. The Karnofsky rating scale (a 100-0 point system to evaluate an individual’s performance status from full functionality to death) was used to measure patients’ quality of life during treatment. The percentage of patients who had a Karnofsky score greater than 40 (disabled, requires special care and help) for at least 50% of the time (the study’s positive quality of life indicator) was 45% in the low group, 75% in the moderately treated group, and 80% for patients receiving high-dose therapy. Differences in mood, sleep quality, and side effects were not significantly different between the groups. Also, there were no significant differences in survival time between the 3 treatment groups. Clinical Implications: The results of this study demonstrate that high dose controlled-release oxycodone offers a safe and effective therapy that includes improved mood, sleep, and quality of life at life’s end. The pain-reliever in moderate and high doses provides a better quality of life for patients who do not respond well to lower doses, without compromising longevity. – WD. Reference: Bercovitch M, Adunsky A. High dose controlled-release oxycodone in hospice care. J Pain Palliat Care Pharmacother. 2006(Dec);20(4):33-39. < Back to Top > Ovarian Cancer Pain Management May Be InadequateThe management of cancer pain at the end of life can be complicated by a patient’s escalating pain intensity, as well as patient and healthcare-provider misconceptions about issues related to drug adverse effects and tolerance. This retrospective study, published in the January issue of the Journal of Pain and Symptom Management, examined analgesic therapy administered to women with ovarian cancer during the last 6 months of life. Analgesic use and pain data from the patient records of 3 health-maintenance organizations between 1995 and 2000 were analyzed. The WHO 3-step analgesic ladder was used to match appropriate treatment with progressive pain intensity. Of particular interest, Step 3 therapy for highest intensity pain involved non-opioids plus weak or strong opioids, including immediate-release and long-acting formulations. Of the entire study population (n=421), 85% had documented pain during their final 6 months of life, yet only 9% of women were administered the highest intensity medications (Step 3) 5 to 6 months before death, At 3 to 4 months before death, the number of patients on a Step 3 regimen increased to 22%, and by 1 to 2 months before death 54% of patients were taking Step 3 medications. Patients aged 70 and older were significantly less likely than younger patients to have a Step 3 opioid drug prescribed. Practice Perspectives: The fact that up to 46% of women with documented pain were never on a Step 3 regimen caused the researchers to question whether there was room for improved pain relief in this study population. The investigators stated that the lack of consistent and systematic pain assessment documentation, was a significant limiting factor –– there was inadequate and inconsistent data regarding the location, duration, and chronicity of pain episodes. Adequate assessment is necessary to provide optimal pain control and the lack of assessment data in this study prevented the investigators from using a more descriptive pain scale in their analyses. Furthermore, the investigators could not fully explain the differences in the use of Step 3 drugs between the older women and those under 70, but stated that it could be partially attributed to concerns regarding opioid tolerance and the fact that the older women may be more likely to suffer in silence. [Comment: For a listing of pain assessment tools, including assessment techniques in non-verbal patients, see the ‘Pain Assessment’ section under the Pain-Topics.org Clinical Concepts tab at http://www.pain-topics.org/clinical_concepts/index.php. Access checked 2/11/07. – WD.] Reference: Rolnick SJ, Jackson J, Nelson WW, et al. Pain management in the last six months of life among women who died of ovarian cancer. J Pain Symptom Manage. 2007(Jan);33(1):24-31. < Back to Top > Weak Evidence on Opioids For Chronic Back PainChronic back pain is a common symptom for which patients frequently request pharmacologic treatment. This systematic review, published in the January Annals of Internal Medicine, attempted to identify the prevalence and effectiveness of opioid prescriptions in adult patients with chronic back pain of longer than 3 months duration. In addition, the risk of substance abuse was evaluated in this population. The investigators identified 38 studies that met inclusion criteria for opioid administration in oral, topical, or transdermal forms for chronic back pain. None of the trials reviewed evaluated opioid effectiveness for a period longer than 16 weeks. Here are some highlights of the review:
Conclusion/Commentary: This review was featured in a number of news stories in the mass media. In one interview, the lead investigator, Bridget Martell, MD, stated that the findings of this review “are not consistent with previous reviews on the efficacy of opioids for chronic back pain.” In fair balance, she cautioned that the reviewed studies “varied widely in quality” and many were of poor quality, either lacking information on trial design or reported only short periods of follow-up. Additionally, most studies on opioid abuse showed no separation between preexisting substance use disorders and current abuse associated with opioid analgesia. Although few, if any, valid conclusions can be drawn from the review, the investigators nonetheless recommended that clinicians should reconsider the use of opioid medications for chronic back pain based on the weak evidence for efficacy in their review. However, from another perspective, this review actually serves to highlight the inadequacies of existing literatureon this subject and it might be inappropriate to base prescribing decisions one way or the other on such findings. – WD, SBL. Reference: Martell BA, O’Connor PG, Kerns RD, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007(Jan):146(2):116-127. < Back to Top > Biases May Exist in Providing ER Diagnostics For Chest PainA large, retrospective study using data from the National Hospital Ambulatory Health Care Survey of Emergency Departments evaluated the differences in 4 noninvasive diagnostic tests received by emergency room (ER) patients presenting with the primary complaint of chest pain. Orders for electrocardiography, cardiac monitoring, pulse oximetry, and chest radiography were reviewed in a sample of 7,068 patients aged 30 years and older during a 6-year period. Race, gender, and insurance differences were evaluated. Results showed that, overall, African American patients were significantly less likely to receive electrocardiography, cardiac monitoring, or pulse oximetry than non-African American patients. African American males were 25% to 30% less likely than non-African American males to receive any of the tests. In a gender comparison, the records showed that African American women were significantly less likely than non-African American men to receive cardiac monitoring or pulse oximetry. Self-pay patients or those covered by insurance other than commercial plans, such as government programs, were 13% to 23% less likely to have diagnostic tests ordered. Practice Perspectives: The investigators acknowledge that this study on a small set of diagnostic tests does not provide a complete picture of the ER decision-making process for patients presenting with chest pain. Plus, the survey data did not allow for an evaluation of the appropriateness of testing or the causes of the differences. However, the researchers express concern about potentially inappropriate healthcare-provider bias and the hope that the results of this study will catalyze further research efforts into the causes of race, gender, and insurance disparities in early cardiac care. Reference: Pezzin LE, Keyl PM, Green GB. Disparities in the emergency department evaluation of chest pain patients. Acad Emerg Med. 2007(Feb);14(2):149-156. < Back to Top > Shoe Insoles Reduce Pain and Stiffness in Knee OsteoarthritisThe pain and stiffness associated with knee osteoarthritis (OA) can increase ambulatory disability originally caused by primary degenerative changes. This pilot study in 28 patients with symptomatic medial-compartment knee osteoarthritis evaluated the benefits of lateral-wedge insoles in walking shoes. The full-length wedge, made of shock absorbing cork composite, was inserted into lightweight shock-absorbing shoes (New Balance 833). The lateral-wedge insole is thinner at the instep and gradually increases to full thickness at the outside edge of the foot (4 degree incline) to shift the weight-bearing load on the diseased knee compartment. In most cases, the patient wore a neutral wedge insole on the unaffected side. Patients were instructed to wear the insole and shoes as long as could be tolerated each day; usual pain medications were to be continued. Changes were compared from baseline to 4 weeks postintervention and assessments were made using a WOMAC instrument (a 24-item questionnaire that addressed joint pain, stiffness, and disability). Almost half of the patients demonstrated a minimum of 20% improvement in the WOMAC subscales and more than 10% reported a 70% improvement. One specific activity, stair walking, showed significant improvement — 64% of participants reported that the insoles provided a 20% improvement and 7% reported a 70% improvement. Clinical Recommendation: The results of this study, although it was uncontrolled, support the fact that a conservative, well-tolerated, inexpensive therapy can offer a significant decrease in pain, stiffness, and disability for appropriate candidates. Support of the feet is an important factor in the progression of knee osteoarthritis and any reduction in disability can improve overall quality of life. The authors recommend that patients suffering from symptomatic medial compartment knee OA should be encouraged by primary providers to consider having a biomechanical evaluation in the early stages of this joint disease. Source: Fang MA, Taylor CE, Nouvong A, et al. Effects of footwear on medial compartment knee osteoarthritis. J Rehabil Res Dev. 2006;43(4):427-434. < Back to Top > IV Lidocaine Relieves Postop Pain, Shortens Hospital StayThe control of postoperative pain is an important factor in the length of time to discharge following surgery. In the January issue of Anesthesiology, investigators report on a randomized, controlled, double-blind study to test the effectiveness of intravenous lidocaine in reducing the postoperative hospital stay by managing pain and improving bowel function. Patients scheduled for a laparoscopic colectomy (n=40) were randomly assigned to a treatment group to receive a low-dose intravenous lidocaine bolus at the induction of anesthesia, a continuous infusion during surgery, and postoperative therapy for 24 hours — or an equal amount of saline solution. In addition to the measurement of pain and fatigue scores, the return of bowel function, opioid consumption, and time to discharge were documented. Pain scores in the lidocaine group were significantly reduced during mobilization and coughing, and postoperative fatigue was reported significantly less often. Bowel function in the treatment group recovered much more quickly than in the control group. Also in the lidocaine group, opioid consumption was significantly reduced (p = 0.005) and postoperative hospital stay was shortened by approximately 1 day (p = 0.001). Adverse effects in the treatment group were minimal; 1 patient experienced nausea. In spite of the fact that the infusion was maintained for 24-hours postoperatively, plasma concentrations of lidocaine were reportedly well below toxic levels at the 24-hour point. Clinical Implications: The investigators concluded that the results provided postoperative recovery benefits in this patient population and facilitated a significant reduction in hospital stay using a protocol that is less expensive and invasive than epidural analgesia. Source: Kaba A, Laurent SR, Detroz BJ, et al. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007(Jan);106(1):11-18. < Back to Top > Chronic Pain in U.S. Workers IncreasingChronic pain has increased in the workplace during the past 10 years, according to a national survey sponsored by Ortho-McNeil, Inc. in partnership with the National Pain Foundation. The survey, “Pain in the Workplace,” was conducted during the last quarter of 2006 and data were compared to a prior survey done in 1996. A sample of 1,103 employed adults and 151 employee benefits managers were surveyed at companies with 150 employees or more. The comparison showed a 10-year increase of 38% in the number of employees who have chronic pain at work (13% vs 18%) and a 37% increase in the number who reported that their pain had persisted for 6 months or more (19% vs 26%). Of the participants with chronic pain, 89% stated that they experienced pain at work and 46% said that their pain (often or sometimes) affected their ability to perform their jobs. And, while nearly 9 out of 10 employees with chronic pain would prefer to go to work when experiencing pain, 65% of employers stated that pain-related issues caused lost productivity in the workplace. The report indicated a growing trend in “presenteeism,” referring to employees being present at work, but producing a lower quality of work due to disabling pain. Worksite wellness programs increased by 65% from 1996 to 2006, but only about 1 in 5 include an educational component related to chronic pain prevention or coping strategies. Practice Perspectives: These survey results add to the growing body of evidence that better management of moderate to moderately severe chronic pain is needed. This survey could provide an opportunity for healthcare providers to ask patients about the existence of chronic pain and recommend pain reduction methods; including behavior modification and non-drug-related therapies, as well as appropriate analgesics. It may be helpful to inform patients that inadequate pain relief has been shown to increase depression, anxiety, sleeplessness, and other symptoms. – WD. Reference: Ortho-McNeil, Inc. and National Pain Foundation. Pain in the workplace. 2007. < Back to Top > Zolmitriptan 5mg Nasal Spray Highly Rated By MigraineursA postmarketing surveillance study of 1,838 patients from 638 medical centers in Germany evaluated zolmitriptan 5mg nasal spray for efficacy and tolerability in the treatment of migraine attacks. Patients were instructed to keep a record of each of the following: time of migraine attack, time of zolmitriptan treatment, time to headache improvement, and time to elimination of pain. In addition, the grade of headache severity (0-10 scale) was recorded immediately before treatment and 2 hours after the spray was administered. Initial patient assessment data showed that just under half of the participants reported 3 or more migraine attacks within the prior 3 months and almost 80% reported attacks that lasted for >/= 12 hours. Overall, half of patients reported the inability to participate in any activity during migraine attacks and 35% needed bedrest. The zolmitriptan nasal spray was used by 80% of patients within 1 hour of the initial headache pain experience. One fourth of participants reported pain reduction within 10 minutes and 85% experienced improvement within 30 minutes. One fifth of patients were pain-free within 30 minutes and about 58% were pain-free 1 hour after treatment. A pain rating of </= 4 was reported by 90% of patients at 2 hours post-treatment and almost 62% could resume their normal daily activities within 1 hour of treatment. Almost 73% rated the zolmitriptan 5mg nasal spray as ‘better’ than previously used treatments, while just over 4% discontinued treatment due to side effects. Clinical Summary: While the investigators acknowledge that this was an uncontrolled study with a 22% rate of questionnaire non-reply, the results were highly favorable for zolmitriptan effectiveness and tolerability. When compared with patients’ previous migraine treatments, physicians rated the effectiveness of the zolmitriptan as ‘much better’ or ‘better’ for 80% of their patients. Fewer than 10% of participants had previous experience with a nasal spray for headache management. The investigators concluded that zolmitriptan 5mg nasal spray is an effective treatment option that offers many migraineurs a fast onset of action for acute attacks. – WD. Source: Diener HC, Evers S. Effectiveness and satisfaction with zolmitriptan 5mg nasal spray for treatment of migraine in real-life practice: results of a postmarketing surveillance study. Clin Drug Investig. 2007(Jan);27(1):59-66. < Back to Top > Trigeminal Neuralgia and Its Treatment Reviewed
The best available evidence for pharmacologic treatment comes from a small number of trials, and includes the following:
Clinical Implications: In cases where the pain is severe and attacks are recurrent, a patient may face a difficult choice regarding treatment; therefore, the clinician must be able to provide the best available information. This condition is relatively uncommon, and the investigators note that further research in diagnosis and treatment is necessary. Reference: Bennetto L, Patel NK, Fuller G. Trigeminal neuralgia and its management. BMJ. 2007(Jan);334(7586):201-205. < Back to Top > Radiopharmaceutical Sm-153 Relieves Metastatic Bone PainCertain types of cancer — such as breast, prostate, lung, kidney, thyroid — tend to metastasize to bone and cause damage that results in pain or fracture. Samarium Sm-153 lexidronam (Sm-153; Quadramet™) is a bone-targeting injectable radiopharmaceutical that delivers radiation to relieve cancer pain. This study evaluated the safety and effectiveness of repeated doses of Sm-153 in patients with recurrent metastatic bone pain. Researchers prospectively collected data from 202 patients in 22 medical centers in the United States, Canada, and Europe; each patient received an initial dose of 1.0 mCi/kg of Sm-153. Of the patients who responded to the first dose of Sm-153, 55 patients with adequate blood cell counts were eligible for additional doses after a subsequent episode of recurrent pain. Hematologic function, pain assessment, and adverse effects were evaluated at baseline, and weekly, following each dose. After each of the first 3 doses, significant decreases in pain scores from baseline were reported by 70%, 63%, and 80% of patients, respectively. The primary adverse events were temporary reductions in platelet levels and white blood cell counts; levels generally recovered within 8 weeks of treatment. Grade 3 thrombocytopenia (low platelet levels) occurred in 11% of patients after the first dose, and in 12% and 17% of patients after the second and third doses, respectively. Grade 3 leukopenia (low white blood cell levels) was experienced by less that 7% of patients after each dose. Practice Perspectives: The researchers concluded that Sm-153 is a safe, effective option to treat metastatic bone pain in patients who experience recurrent pain after a successful first dose. They further state that Sm-153 is a “reasonable treatment option – provided that hematologic function is present at the time of drug administration.” Sm-153 can offer an alternate therapy for patients who need longer-term pain relief, which may also provide an opportunity to decrease the use of opioid analgesics. Administration is usually done on an outpatient basis. Reference: Sartor O, Reid RH, Bushnell DL, et al. Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Cancer. 2007(Feb);109(3):637-643. < Back to Top > EUROPAD Journal Available Free at Pain-Topics.org
Go to: http://www.pain-topics.org/opioid_rx/europad.php. < Back to Top > Recent Drug and Device Approvals and Announcements
Additionally, the FDA Center for Drug Evaluation and Research website offers the option to search on any approved drug name or active ingredient at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, and safety information is posted by FDA’s MedWatch at http://www.fda.gov/medwatch/safety/2006/safety06.htm. Rituxan® (rituximab) – FDA Advisory on Adverse Events Celebrex™(celecoxib) Approved for the Treatment of Juvenile Rheumatoid Arthritis (JRA) Vicoprofen® (hydrocodone bitartrate plus ibuprofen): Safety Labeling Revisions Depakote® (divalproex sodium): Safety Labeling Revisions Upgraded Ipump Pain Management System Receives Approval Empi Select™ TENS Device Gets FDA Approval < Back to Top >
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Trigeminal neuralgia, a painful chronic condition that affects the 5th cranial nerve (also called ‘tic douloureux’), can be a diagnostic and management challenge to clinicians. A review, published in the January issue of the British Medical Journal, summarizes the pathophysiology, differential diagnosis, and evidence for the effective treatment of trigeminal neuralgia. Research suggests that trigeminal nerve compression near the exit point of the brainstem is the cause of pain in 80% to 90% of cases. The key feature is a sudden and severe lancinating pain, which usually lasts from a few seconds to 2 minutes, within the trigeminal nerve distribution, typically the maxillary (30% of cases) or mandibular branches (35%) – see Figure.
Heroin Addiction and Related Clinical Problems, the official journal of EUROPAD (European Opiate Addiction Treatment Association), is a peer-reviewed publication for professionals wanting to stay informed of research and opinion on opioid-misuse and its treatment. A particular emphasis is on medication-assisted treatments for opioid addiction, with many articles addressing the interface of pain and addiction. Courtesy of EUROPAD, full copies of all journal editions are available for free download as PDF documents at the Pain-Topics.org website.
Following are briefs on new pain-management drug or device approvals as well as items related to safety concerns for existing products. If the FDA news website posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.