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Home > News/Research Updates > 2005-2006 Index > Issue 4

July-August 2006; Issue 4

New Guidance for Managing Opioid-Induced Constipation
Breakthrough Noncancer Pain is Common
QTc Effects in Switching From Morphine to Methadone
Opioids Effective for Neuropathic Pain
Nonmedical Use of Opioid Analgesics Rising
Traditional & Sham Acupuncture Both Reduce Knee Pain
How to Encourage Exercise in Arthritis Sufferers
Hyperthermia Reduces Rotator Cuff Pain
Pain Often First Reported Symptom of Oral Cancer
Water Aerobics Reduces Low Back Pain in Pregnancy
Key Factors in Reversing Chronic Migraine
Standard Maximum Acetaminophen Dose Linked to Liver Problems
Anesthesia/Analgesia in Substance-Addicted Persons
The ‘Right’ Needle Reduces Injection Pain
Recent Drug Approvals and Announcements

This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN, and edited by Stewart B. Leavitt, MA, PhD. Medical reviewers were: Lee A. Kral, PharmD, BCPS; James D. Toombs, MD; Paul W. Lofholm, PharmD, FACA. Posting Date: August 25, 2006.

New Guidance for Managing Opioid-Induced Constipation

Opioid-Induced ConstipationConstipation is a frequent, many believe inevitable, side effect of opioids since these agents decrease peristaltic activity in the gastrointestinal tract. The distress of constipation may add to the discomfort already present from pain, and patients might decrease or discontinue their opioid medication to avoid constipation. So, motivating such patients to comply with their opioid therapy also requires a special approach for managing constipation.

A new research report from Pain Treatment Topics discusses the challenges of overcoming opioid-induced constipation and provides practical guidance for its management:

  • Clinicians should anticipate the constipating side effects of opioid analgesics and discuss them with patients whenever starting opioid therapy.
  • Given the high variability among patients, characterizing a person as constipated based only on the number of bowel movements per day or week is inappropriate.
  • Prevention is the best approach to managing constipation, and an appropriate bowel regimen should be tailored for each patient’s needs when beginning opioid therapy.
  • Effective treatment and management of opioid-induced constipation usually requires laxatives; most commonly a combination stool softener and stimulant.
  • Bulk-forming laxatives must be avoided in opioid-induced constipation, because intestinal blockage might occur due to inhibited peristalsis.

Practice Pointers: Because of the mechanisms involved in opioid-induced constipation, some treatments that may be applicable for common, functional constipation are inappropriate for ambulatory-care patients prescribed opioid analgesics. For example, available evidence does not indicate that opioid-induced constipation can be helped merely by increasing intake of fluids or dietary fiber, unless the patient is dehydrated or consuming a fiber-deficient diet. Similarly, increasing activity or exercise levels is of limited value in dealing with opioid-induced constipation and may be inappropriate for many patients with pain.

Reference: Goodheart CR, Leavitt SB. Managing Opioid-Induced Constipation in Ambulatory-Care Patient. Pain Treatment Topics – Special Report. August 2006. A PDF of the 9-page report is available for free download at: http://www.pain-topics.org/opioid_rx/index2.php#constipation. Access checked August 15, 2006.

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Breakthrough Noncancer Pain is Common

Breakthrough pain is well-characterized in cancer patients but not in patients with chronic noncancer pain (CNCP). Researchers recruited 228 patients with diverse types of CNCP from 9 pain programs and administered a telephone questionnaire with a breakthrough pain assessment algorithm originally designed for cancer patients. All patients had controlled baseline pain, and nearly three-quarters (74%) experienced severe to excruciating breakthrough pain.

Among those with breakthrough pain, the most common syndrome was low back pain (52%), and the underlying pathophysiology was variably characterized as somatic (38%), neuropathic (18%), visceral (4%), or mixed (40%). In all, 189 different types of breakthrough pain were reported. The median number of episodes per day was 2 (range, <1-12). Median time to maximum intensity was 10 minutes, and median duration of the breakthrough pain was 60 minutes (range, 1-720 min). Patients identified a precipitant for 69% of pains, and 92% of these were activity-related as might be expected. Onset could never be predicted for 45% of pains and only sometimes predicted for 31% of pains.

Clinical Perspectives:Breakthrough pain is highly prevalent and varied in the CNCP population, and requires ongoing consideration by practitioners. Further studies are warranted to clarify whether the clinical impact and therapeutic challenges posed by this phenomenon are comparable to the cancer patient population.

Source: Portenoy RK, Bennett DS, Rauck R, et al. Prevalence and characteristics of breakthrough pain in opioid-treated patients with chronic noncancer pain. J Pain. 2006(Aug);7(8):583-591.

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QTc Effects in Switching From Morphine to Methadone

Case reports and retrospective studies suggest that methadone causes an increase in QTc (QT-interval on the electrocardiogram time-corrected for heart rate) and risk of torsades de pointes arrhythmia. No prospective studies in pain patients have been conducted, and data on whether a methadone-induced increase in QTc persists during long-term treatment have not been reported.

Eight patients with chronic nonmalignant pain, experiencing insufficient pain control or intolerable side effects during treatment with oral morphine and switched to oral methadone were included in this prospective study.

Electrocardiograms were obtained at baseline and at follow-up 2 weeks, and 3 and 9 months after the opioid switch. The start of methadone caused a minor but statistically significant increase in QTc, while fluctuations in QTc during treatment with stable doses of methadone were neither clinically nor statistically significant. No episodes of arrhythmia were observed.

[Comment: This small case series from Norway is unique in that patient evaluations began in advance of methadone therapy and the subjects were followed during a 9-month period. The results suggest that in some patients increases in QTc interval might be expected when switching from other opioids to methadone therapy, but those increases are minor and tend to stabilize over time. However, other research suggests that there might be concerns regarding potential arrhythmia with methadone in patients with pre-existing cardiac conditions and clinicians should be aware of those. For an evidence-based discussion and guidance regarding cardiac concerns in patients receiving methadone, see: http://www.atforum.com/SiteRoot/pages/rxmethadone/cardiacmmt.shtml. This paper addresses methadone maintenance treatment for opioid addiction; however, similar principles would apply with methadone analgesia. – SB Leavitt, MA, PhD.]

Source: Fredheim OM, Borchgrevink PC, Hegrenaes L, Kaasa S, Dale O, Klepstad P. Opioid switching from morphine to methadone causes a minor but not clinically significant increase in QTc time: a prospective 9-month follow-up study. J Pain Symptom Manage. 2006 Aug;32(2):180-185.

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Opioids Effective for Neuropathic Pain

The use of opioids for neuropathic pain remains controversial. Small studies have yielded equivocal results and have not established the long-term risk-benefit ratio of this treatment. To assess the efficacy and safety of opioid agonists for the treatment of neuropathic pain, investigators conducted a Cochrane Systematic Review of the literature and identified 23 trials meeting inclusion criteria. Of these, 14 were considered short-term trials (<24 hours) and 9 were of intermediate duration (median 28 days).

The short-term trials had contradictory results; however, all 9 intermediate-term trials demonstrated opioid efficacy for spontaneous neuropathic pain. Meta-analysis of 7 intermediate-term studies showed mean post-treatment visual analog scale scores of pain intensity after opioids to be 13 points lower on a scale from zero to 100 than after placebo (p < 0.00001). The most common adverse events were nausea (33% opioid versus 9% control) and constipation (33% vs 10%), followed by drowsiness (29% vs 12%), dizziness (21% vs 6%), and vomiting (15% vs 3% control).

Clinical Conclusions: The authors suggest that intermediate-term studies demonstrate significant efficacy of opioids for neuropathic pain compared with placebo, which is likely to be clinically important. Reported adverse events of opioids are common but not life threatening. Further randomized controlled trials are needed to establish longer-term efficacy, safety (including addiction potential), and effects on quality of life.

Reference: Eisenberg E, McNicol E, Carr D. Opioids for neuropathic pain. Cochrane Database Syst Rev. 2006(Jul);3:CD006146.

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Nonmedical Use of Opioid Analgesics Rising

According to government research, the nonmedical use of pain medications increased by 2.4 million persons in the United States between 2002 and 2004. An analysis of the most recent National Survey on Drug Use and Health (NSDUH) Report by the Substance Abuse and Mental Health Services Administration (SAMHSA) showed that, as of the 2004 data, approximately 32 million Americans 12 years of age and older have used analgesics for nonmedical purposes within their lifetime. Among those who initiated nonmedical use of pain relievers during 2004 alone, the Graph depicts the relative percentage various analgesics involved (drugs not shown were used by fewer than 3% of initiates).

Nonmedical Use of Opioid Analgesics Rising

The SAMHSA survey indicated that more people started using prescription pain medications for recreational use than the estimated number of new users of marijuana or cocaine. The average age of first-time nonmedical users of pain relievers was 23 years; more than half (about 55%) were women.

Investigators emphasized specific concerns regarding the increasing use of OxyContin®, a controlled-release version of oxycodone hydrochloride, because lifetime recreational use of this agent rose to 3.1 million people from 1.9 million in 2 years. The majority of OxyContin initiates had previously used other substances: another illegal drug (99.1%), alcohol (99.4%), marijuana (97.1%), another analgesic (97.4%), and hallucinogens (71.1%) topped the list.

Practice Pointers: Preventing prescription analgesic misuse is an important component of patient care. Patient assessment must include screening questions to identify all prescription and OTC drugs taken by each patient. It is important to be alert for any symptoms that might reflect current substance misuse or abuse. To remain vigilant for the development of tolerance or misuse issues, healthcare providers should monitor refill requests for all pain relievers.

[Comment: In this report, “nonmedical” use is defined as the use of prescription-type drugs not prescribed for the respondent by a physician, or used only for the experience or feeling they caused. Therefore, the data may be distorted by including the unauthorized use (misuse) of prescription analgesics by persons who obtain such drugs from others (eg, friend, relative) for medical purposes (ie, pain relief); such a distinction does make a difference in defining the true scope of the problem and remedial actions. It also is of interest that, contrary to alarming reports in the news media, the relative incidence of methadone nonmedical use was minor, involving <3% of initiates. – SB Leavitt, MA, PhD.]

Reference: SAMHSA/OAS. Nonmedical users of pain relievers: characteristics of recent initiates. NSDUH Report. 2006, Issue 22. Available online at http://www.oas.samhsa.gov/2k6/pain/pain.pdf (access checked August 16, 2006).

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Traditional & Sham Acupuncture Both Reduce Knee Pain

The pain of osteoarthritis is a challenge to clinicians and patients alike and, because there is no cure, symptoms are frequently managed using multiple modalities. A study compared symptom reduction in patients treated with traditional Chinese acupuncture (TCA) versus sham acupuncture (defined as minimal-depth needling at non-traditional points). A total of 1007 patients, 40 years of age and older, with chronic knee pain of 6 months duration were randomly assigned to one of three interventions: 1) 6-week treatment regimen consisting of 10 sessions of TCA, 2) 10 sessions of sham procedure, or 3) 10 physician visits. All patients received anti-inflammatory drugs as needed plus up to 6 physiotherapy sessions. Patients in both acupuncture groups were blinded to treatment type. Any patient who met the criteria for partial treatment success could receive up to 5 added sessions or visits.

At the 26-week evaluation point, both acupuncture groups had higher success rates (53% for TCA and 51% for sham) than the physician visits which demonstrated a 29% success rate. Success was defined as a minimum of 36% improvement in osteoarthritis index scores.

Clinical Concept: The investigators state that they support the use of acupuncture even thought the exact mechanisms of the results are unclear at this time. In addition, they suggest that more research is needed to determine whether the similar results observed between the TCA and sham procedures are a result of the placebo effect, the physiologic effect of needling regardless of procedural style, or the quality of the contact with the healthcare provider. [Comment: The adjunctive use of anti-inflammatory drugs and physiotherapy sessions might have been confounding factors in this study. – SB. Leavitt, MA, PhD.]

Reference: Scharf HP, Mansmann U, Streitberger K et al. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006(Jul);145(1):12-20.

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How to Encourage Exercise in Arthritis Sufferers

While exercise has been shown to reduce pain and improve functionality in arthritis patients, the rates of inactivity are higher in patients with arthritis than individuals without arthritis. To learn more about the perceived barriers and benefits of exercise, investigators assigned 68 arthritis sufferers to 12 focus groups divided by exercise levels, socioeconomic status, and race. Exercisers and nonexercisers were defined according to their relative participation in moderate activity or strength training at least 3 days per week.

The results showed that regular exercise was influenced by a combination of physical, social, psychological, and environmental factors. Over time, exercisers stated that they had experienced relief of pain and stiffness while achieving increased mobility; however, they had difficulty finding the time to complete exercise routines. Nonexercisers were concerned about whether or not a temporary rise in pain due to increased activity would be worthwhile, and they were more likely to express the belief that they were not physically able to exercise. Additional barriers included lack of support for exercise from physicians and the low availability of arthritis-specific exercise programs in the community.

Practice Pointers: It is important for healthcare providers to prescribe exercise as well as referrals to programs whenever possible. Patients should also be provided with specific information on how to manage pain and stiffness before and after activity, and how to modify exercises based on disability. Offering printed materials may provide the necessary support to encourage and sustain exercise participation.

[Comment: The Arthritis Foundation offers a free 12-page booklet entitled “Exercise and Your Arthritis” that explains the benefits of staying active and presents basic flexibility exercises with instructions (including illustrations). It is available at: http://www.arthritis.org/conditions/onlinebrochures/Exercise.pdf (access checked August 16, 2006). In addition, their new 2006 DVD entitled “Take Control With Exercise” is a 60-minute exercise program for people with all levels of disability and can be purchased for $19.95 by calling 1-800-283-7800 or visiting the Arthritis Foundation website at http://afstore.arthritis.org/AFConsumerStore/SearchProductAction.do?_$action=Search&text=Take%20Control (access checked October 30, 2007). – W Dawson, MA, RN, BSN.]

Reference: Wilcox S, Der Ananian C, Abbott J, et al. Perceived exercise barriers, enablers, and benefits among exercising and nonexercising adults with arthritis: results from a qualitative study. Arth Care Res. 2006(Aug);55(4):616-627.

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Hyperthermia Reduces Rotator Cuff Pain

Rotator cuff tendon injuries are common and many patients are referred to physical therapy for various treatment modalities. Hyperthermia (therapeutic deep-heating of localized tissues) is increasingly being used in physical therapy and this pilot study compared that with 2 other modalities.

Investigators randomized 37 athletes with rotator cuff tendinopathy to either 1) Hyperthermia sessions 3 times per week for 4 weeks, 2) ultrasound therapy 3 times per week for 4 weeks, or 3) passive exercises performed twice every day for 4 weeks. The only therapy demonstrating a statistically significant reduction of pain was hyperthermia, with average pain of 5.96 at baseline reduced to 1.2 at the 6-week post-treatment evaluation (measured by visual analog scale). In addition, at the 6-week follow-up, almost 80% of athletes receiving hyperthermia felt ready to return to practicing their sport; whereas, fewer ultrasound (50%) and exercise (35%) participants stated a readiness to return. While 4 hyperthermia participants reported temporary discomfort from the heat, none of the treatments were interrupted and there were no adverse effects.

Clinical Concept: The researchers point out that positive study results in athletes may not apply to the general population; however, they believe that the results support the short-term use of hyperthermia at 434 MHz (microwave) in supraspinatus tendinopathy. They were not able to define reasons for the effective pain reduction but surmised that it could be related to the fact that slightly higher temperatures have previously been shown to increase blood flow due to the warming of tissues. More studies across varied populations are encouraged.

Reference: Giombini A, Di Cesare A, Safran MR, et al. Short-term effectiveness of hyperthermia for supraspinatus tendinopathy in athletes. Amer J Sports Med. 2006(Aug);34(8):1247-1253.

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Pain Often First Reported Symptom of Oral Cancer

This retrospective analysis evaluated the hospital charts of 1412 patients diagnosed with oral squamous cell carcinoma between 1977 and 1998. Ages ranged from 13 to 87 years (mean 56.3) and approximately 17% were female and 83% were male.

Analysis showed that pain was the chief complaint in nearly 20% of patients and 12 different types of pain were noted. Almost 40% complained of sore throat and 11% complained of pain when swallowing. Reports of pain in the tongue (14%) or mouth (12%) followed, and single figure percentages were reported for dental pain, earache, palate pain, burning mouth, gingival pain, neck pain, and pain when chewing. The incidence of oral cancer in this survey was higher in men than women (4-to-1), and the report of pain as the initial complaint was also higher in men than women. Pain reports showed a high correlation to advanced stages of tongue and tongue/floor cancer sites and 88% of total pain reports were staged as III or IV (by TNM staging which evaluates tumor, nodes, and metastasis).

Practice Pointers: These study results suggest that mouth and throat pain must by thoroughly evaluated, and a multidisciplinary approach may be needed for a comprehensive diagnosis. The researchers suggest that additional prospective studies would be useful to further define the characteristics of initial reports of oral cancer pain, as well as to create criteria that could improve the differential assessment of orofacial pain.

Reference: Cuffari L, Tesseroli de Siqueira JT, Nemr K, et al. Pain complaint as the first symptom of oral cancer: a descriptive study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006(Jul);102(1):56-61.

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Water Aerobics Reduces Low Back Pain in Pregnancy

Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related low back pain (PLBP) are common conditions that can cause a significant number of symptoms and disability. A total of 390 pregnant women participated in a randomized study comparing the symptom reduction effects of land-based physical exercise (LBPE) with water aerobics. Both interventions were designed specifically for pregnant women and were led by experienced instructors.

Most participants started their weekly sessions during the 17th gestational week and each session included 45 minutes of activity and 15 minutes of relaxation. The women in the LBPE group attended an average of 13.5 sessions and those participating in water aerobics had an average of 16.2 sessions.

During the study, about 40% of the women reported experiencing symptoms of PLBP or PPP or both. However, none of the women in the water aerobics group and 6 land-based exercise participants needed sick leave due to PLBP. Low back pain was present in 14% of the water aerobics participants compared with 25% of the LBPE group. For the women experiencing PPP, the incidence of pain and sick leave were about equal between the two groups.

Practice Pointers: The authors state that over a third of pregnant women experience back pain during their pregnancy and long-term low back pain begins during pregnancy in 10% to 15% of cases. Pregnant women need a moderate level of physical activity as long as it is appropriate during the pregnancy. Water aerobics demonstrated the benefits of low back pain reduction and lower sick leave in this study. Water aerobics is a moderate and inexpensive form of physical activity and can be recommended to pregnant women, provided access to such a program can be provided.

Reference: Granath AB, Hellgren MSE, Gunnarsson RK. Water aerobics reduces sick leave due to low back pain during pregnancy. J Obstet Gynecol Neonatal Nurs. 2006(Jul-Aug);35(4):465-471.

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Key Factors in Reversing Chronic Migraine

One subtype of chronic daily headache (CDH) is the transformed migraine, an episodic migraine that eventually becomes chronic. A study in 136 patients from a single headache clinic investigated factors that assisted patients in reverting from chronic back to episodic migraine status. Each patient completed a questionnaire that included information on CDH onset, headache frequency and duration, analgesic use and overuse, caffeine and alcohol use, tobacco use, exercise frequency, and family history of headache.

Treatment consisted of improving compliance with preventive medications, modifying lifestyle factors such as smoking cessation and an increase in regular exercise, and complete discontinuation of overused medications. About 70% of study patients were converted from CDH to episodic migraine at the end of one year. Of the 30% of patients (n=41) who did not revert to episodic migraines, 4 were found to be taking analgesics for a medical condition other than headaches.

Practice Pointers: Researchers stated that studies have shown that analgesic medication overuse can be one cause of the failure of migraine-preventive drugs because the headaches become refractory. In addition, their experience indicated that the control of analgesic overuse was essential and discontinuation resulted in improvement in headache frequency. Because the baseline reasons for poor compliance with preventive drugs were reported as ineffectiveness and side effects, patient follow-up is important after a new preventive regimen is initiated.

Reference: Seok JI, Cho HI, Chung CS. From transformed migraine to episodic migraine: reversion factors. Headache. 2006(Jul);46(7):1186-1190.

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Standard Maximum Acetaminophen Dose Linked to Liver Problems

In a small study, adults taking standard maximum doses of acetaminophen for two weeks had abnormal liver test results, raising concerns that even recommended amounts of the popular painkiller might lead to liver damage. Investigators sought to characterize the incidence and magnitude of ALT elevations in healthy participants receiving 4 g of acetaminophen daily, either alone or in combination with selected opioids, as compared with participants treated with placebo. The study enrolled 145 healthy adults in 2 US inpatient clinical pharmacology units; the design was randomized, single-blind, placebo-controlled, with 5 parallel-treatment groups, and diet-controlled (meals provided).

Each participant received either placebo (n = 39), 1 of 3 acetaminophen/opioid combinations (n = 80), or acetaminophen alone (n = 26). Each active treatment included 4 g of acetaminophen daily, the maximum recommended daily dosage. The intended treatment duration was 14 days.

None of the 39 participants assigned to placebo had a maximum ALT of more than 3 times the upper limit of normal. In contrast, the incidence of maximum ALT of more than 3 times the upper limit of normal was 31% to 44% in the 4 treatment groups receiving acetaminophen, including those participants treated with acetaminophen alone. Trough acetaminophen concentrations did not exceed therapeutic limits in any participant and, after active treatment was discontinued, often decreased to undetectable levels before ALT elevations resolved.

Practice Pointers: Initiation of recurrent daily intake of 4 g of acetaminophen in healthy adults is associated with ALT elevations and concomitant treatment with opioids does not seem to influence this effect. History of acetaminophen ingestion should be considered in the differential diagnosis of serum aminotransferase elevations, even in the absence of measurable acetaminophen concentrations in serum.

[Comment: In an interview, one of the study authors, Neil Kaplowitz of the University of Southern California, stated, “I would urge the public not to exceed 4 grams a day. This is a drug that has a rather narrow safety window, and heavy drinkers should take no more than 2 grams daily.” Acetaminophen is included in numerous over-the-counter and prescription medications, making overdose possible as people unwittingly combine drugs; such overdoses of acetaminophen are the leading cause of acute liver failure. Also see prior Pain-Topics Update item, “Acetaminophen-Induced Acute Liver Failure Increasing,” available at: http://www.pain-topics.org/news_research_updates/index1.php#liver (access checked August 16, 2006). – SB Leavitt, MA, PhD.]

Reference: Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily. A randomized controlled trial. JAMA. 2006(Jul 5);296:87-93.

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Anesthesia/Analgesia in Substance-Addicted Persons

In a review article from Germany, the authors note that persons with the disease of substance addiction have an exaggerated organic and psychological comorbidity, and in cases of major surgery or polytrauma they are classified as high-risk patients. Perioperative challenges include: a higher analgesic requirement, drug craving, physical and/or psychological withdrawal symptoms, hyperalgesia, and drug tolerance. However, the clinical expression these depends on the substance that was abused.

For a better understanding of the necessary perioperative measures, it is helpful to classify the substances into central nervous system depressors (eg, heroin/opioids, alcohol, sedatives, hypnotics), stimulants (eg, cocaine, amphetamines, designer drugs), and other psychotropic substances (eg, cannabis, hallucinogens, inhalants). The perioperative analgesia therapy itself should not be considered as treating the addiction, as this is senseless, the authors state. The characteristics of this chronic disease must be understood and accepted; anesthesia and analgesia generally must be stress-protective and provide sufficient pain relief.

Equally important, perioperative treatment should include physical stabilization of drug dependence by substitution with methadone (for opioid addicts) or benzodiazepines/clonidine (for alcohol, sedatives, and hypnotics addiction). Further actions include: intraoperative and postoperative stress relief by using regional anesthesia techniques or systematically higher than normal dosages of anesthetics, strict avoidance of inadequate dosages of opioid analgesics, postoperative optimization of regional or systemic analgesia by non-opioids, and consideration of the complex physical and psychological characteristics and comorbidities.

Even in cases of formerly addicted patients who have been drug-abstinent, an inadequate analgesic dosage must be avoided since this – and not adequate pain therapy, even with strong opioids – can potentially activate addiction. A protracted abstinence syndrome following abstinence from illicit opioids can lead to increased response to perioperatively administered opioids (eg, analgesia, side-effects).

Source: Jage J, Heid F. Anesthesia and analgesia in addicts: basis for establishing a standard operating procedure [in German, English abstract]. Anaesthesist. 2006(Jun);55(6):611-628.

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The ‘Right’ Needle Reduces Injection Pain

A letter in the August Journal of Pain provides results of case series comparing injection needles from 2 different manufacturers. The clinician/researchers noticed that patients receiving subcutaneous (SQ) injections were voicing more complaints than those being treated with intramuscular (IM) injections, and they were puzzled because the IM needles were more than twice the length of the SQ needles; however, they found that the needles were from different manufacturers. A comparison was made between 25G 5/8-inch Terumo Medical Corp. needle and the same size Becton Dickinson & Co. needle.

Twenty consecutive patients received SQ anesthetic injections in 2 different sites by the same clinician. Patients rated the level of pain on a 10-point scale and the results showed that the mean average pain score for the Becton Dickinson needle was 1.9 (range 0-6) and the Terumo needle scored 5.5 (range 3-10).

Clinical Concept: The researchers concluded that the difference in pain experience was based on the bevel design of the needles and not the length. Because good patient care involves providing healthcare services in ways that minimize discomfort, this study serves as a reminder that patient complaints should be monitored to continuously identify even small ways of improving therapeutic procedures and care.

Source: Jage J, Heid F. Anesthesia and analgesia in addicts: basis for establishing a standard operating procedure [in German, English abstract]. Anaesthesist. 2006(Jun);55(6):611-628.

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Recent Drug Approvals and Announcements

This section contains briefs on new drug approvals in pain management 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.

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.

Humira® Approved for Ankylosing Spondylitis
This tumor necrosis factor [alpha] antagonist is used in the treatment of rheumatoid arthritis and was approved in July by the FDA for treating the symptoms of active ankylosing spondylitis, a painful autoimmune disease that causes inflammation and stiffness in young adults. In addition, the Humira Pen is a new drug delivery device offering a less-painful self-administration option for Humira and should be available soon, according to Abbott Laboratories.

Meloxicam: Generic Mobic® Available
This lower-cost non-steroidal anti-inflammatory (NSAID) drug for the treatment of the symptoms of osteoarthritis was approved by the FDA in July. Thirteen abbreviated new drug applications received approval for meloxicam which is the generic form of Boehringer Ingelheim’s Mobic.

Opana® and Opana ER®: New Oral Oxymorphone Formulations
These semi-synthetic opioid analgesics from Endo Pharmaceuticals Inc. were approved in 2 oral formulations for moderate-to-severe pain. Opana ER uses oxymorphone hydrochloride in an extended-release system that is designed to provide consistent delivery of the drug for pain relief over a 12-hour period. It is intended for patients who need around-the-clock analgesia and is available in 5 mg, 10 mg, 20 mg, and 40 mg tablets. The immediate-release version of oxymorphone hydrochloride (Opana) is indicated for acute pain when opioid therapy is appropriate. Both products were approved by the FDA in June 2006 and the company also plans to re-launch its oxymorphone injectable with the new trade name.

Synera® Topical Anesthesia Patch
A topical anesthetic patch containing a formulation of 70 mg each of lidocaine and tetracaine has been approved for use in adults and children >4 months of age to reduce the pain of venipuncture and superficial dermatology procedures. The patch looks like a bandage and contains an oxygen-activated heating component that enhances the delivery of the topical anesthetic agents. Synera was approved in June 2005 but was just recently launched by Zars Pharma in the United States in July 2006.

Zostavax® Shingles Vaccine Introduced
A new vaccine from Merck & Co. reduces the incidence of shingles in older adults who harbor the chickenpox virus. The vaccine works by enhancing immunity to the varicella-zoster virus to prevent viral reactivation. Shingles is more prevalent than many healthcare providers realize, affecting about 20% of people 60 years of age and older. In 10 years of testing, Zostavax demonstrated a 50% reduction in the incidence of the painful condition and, subsequently, the potential development of postherpetic neuralgia which is a common sequela in older adults. It is not a treatment for shingles, nor is it intended to prevent the initial infection.

Warning: Combining Triptans With SSRIs or SNRIs May Be Harmful
The use of 5-hydroxytryptamine receptor antagonists (also called “triptans”) in patients taking selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs) can result in an additive effect on serotonin levels. Concurrent administration of these drugs could put a patient at risk for serotonin syndrome, which can become life-threatening. SSRIs (Celexa®, Fluvoxamine, Lexapro®, Paxil®, Prozac®, Symbyax®, Zoloft®) and SNRIs (Cymbalta®, Effexor®) are used to treat mood disorders like depression; triptans are commonly prescribed for migraine headaches. Examples of triptans include: Amerge®, Axert®, Frova®, Imitrex®, Maxalt®, Relpax®, and Zomig®.

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