Assessment and management of donor pain following marrow harvest for allogeneic bone marrow transplantation

We studied the time course and intensity of pain of multiple bone marrow aspirations in 30 healthy adult marrow donors receiving acetaminophen with codeine for analgesia immediately after marrow harvesting for allogeneic bone marrow transplantation. Upon discharge, donors were supplied with acetaminophen (315 mg) plus codeine (30 mg) tablets and instructed to use one or two tablets up to every 4 h as needed for pain control. Donors used analgesic medication for a mean (+/- SE) of 3.3 +/- 0.5 days (range = 1-13 days) and reported less than complete pain relief. Subjects reported more pain at time of medication than between doses, indicating that the analgesic was at least partially effective. Male donors tended to report more pain and use more analgesic than did females. We conclude that donors self-regulate their analgesic usage to achieve maximal relief and that incomplete relief with acetaminophen plus codeine may be due to limited efficacy of this analgesic preparation. Our findings suggest that donor pain management may be improved by use of more powerful analgesics.     

A Novel Interdisciplinary Analgesic Program Reduces Pain and Improves Function in Older Adults After Orthopedic Surgery

OBJECTIVES: To examine the effect of a multicomponent intervention on pain and function after orthopedic surgery.
DESIGN: Controlled prospective propensity score–matched clinical trial.
SETTING: New York City acute rehabilitation hospital.
PARTICIPANTS: Two hundred forty-nine patients admitted to rehabilitation after hip fracture repair (n=51) or hip (n=64) or knee (n=134) arthroplasty.
INTERVENTION: Pain assessment at rest and with physical therapy (PT) by staff using numeric rating scales (1 to 5). Physician protocols for standing analgesia and preemptive analgesia before PT were implemented on the intervention unit. Control unit patients received usual care.
MEASUREMENTS: Pain, analgesic prescribing, gait speed, transfer time, and percentage of PT sessions completed during admission. Pain and difficulty walking at 6, 12, 18, and 24 weeks after discharge.
RESULTS: In multivariable analyses intervention patients were significantly more likely than controls to report no or mild pain at rest (66% vs 49%, P =.004) and with PT (52% vs 38%, P =.02) on average for the first 7 days of rehabilitation, had faster 8-foot-walk times on Days 4 (9.3 seconds vs 13.2 seconds, P =.02) and 7 (6.9 vs 9.2 seconds, P =.02), received more analgesia (23.6 vs 15.6 mg of morphine sulfate equivalents per day, P <.001), were more likely to receive standing orders for analgesia (98% vs 48%, P <.001), and had significantly shorter lengths of stay (10.1 vs 11.3 days, P =.005). At 6 months, intervention patients were less likely than controls to report moderate to severe pain with walking (4% vs 15%, P =.02) and that pain did not interfere with walking (7% vs 18%, P =.004) and were less likely to be taking analgesics (35% vs 51%, P =.03).
CONCLUSION: The intervention improved postoperative pain, reduced chronic pain, and improved function.     

Do gender and race affect decisions about pain management?

OBJECTIVE: To determine if patient gender and race affect decisions about pain management. DESIGN, SETTING, AND PARTICIPANTS: Experimental design using medical vignettes to evaluate treatment decisions. A convenience sample of 111 primary care physicians (61 men, 50 women) in the Northeast was asked to treat 3 hypothetical patients with pain (kidney stone, back pain) or a control condition (sinusitis). Symptom presentation and severity were held constant, but patient gender and race were varied. MEASUREMENTS AND MAIN RESULTS: The maximum permitted doses of narcotic analgesics (hydrocodone) prescribed at initial and return visits were calculated by multiplying mg per pill x number of pills per day x number of days x number of refills. No overall differences with respect to patient gender or race were found in decisions to treat or in the maximum permitted doses. However, for renal colic, male physicians prescribed higher doses of hydrocodone to white patients versus black patients (426 mg vs 238 mg), while female physicians prescribed higher doses to blacks (335 mg vs 161 mg, F1,85 = 9.65, P =.003). This pattern was repeated for persistent kidney stone pain. For persistent back pain, male physicians prescribed higher doses of hydrocodone to males than to females (406 mg vs 201 mg), but female physicians prescribed higher doses to females (327 mg v. 163 mg, F1,28 = 5.50, P =.03). CONCLUSION: When treating pain, gender and racial differences were evident only when the role of physician gender was examined, suggesting that male and female physicians may react differently to gender and/or racial cues.     

Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind,randomized, placebo-controlled study

PURPOSE: To evaluate the efficacy and safety of a combination analgesic tablet (37.5 mg tramadol/325 mg acetaminophen) for the treatment of fibromyalgia pain. METHODS: This 91-day, multicenter, double-blind, randomized, placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo. The primary outcome variable was cumulative time to discontinuation (Kaplan-Meier analysis). Secondary measures at the end of the study included pain, pain relief, total tender points, myalgia, health status, and Fibromyalgia Impact Questionnaire scores. RESULTS: Of the 315 subjects who were enrolled in the study, 313 (294 women [94%], mean [+/- SD] age, 50 +/- 10 years) completed at least one postrandomization efficacy assessment (tramadol/acetaminophen: n = 156; placebo: n = 157). Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo (48% vs. 62%, P = 0.004). Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study (53 +/- 32 vs. 65 +/- 29 on a visual analog scale of 0 to 100, P <0.001), and better pain relief (1.7 +/- 1.4 vs. 0.8 +/- 1.3 on a scale of -1 to 4, P <0.001) and Fibromyalgia Impact Questionnaire scores (P = 0.008). Indexes of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the tramadol/acetaminophen-treated subjects. Discontinuation due to adverse events occurred in 19% (n = 29) of tramadol/acetaminophen-treated subjects and 12% (n = 18) of placebo-treated subjects (P = 0.09). The mean dose of tramadol/acetaminophen was 4.0 +/- 1.8 tablets per day. CONCLUSION: A tramadol/acetaminophen combination tablet was effective for the treatment of fibromyalgia pain without any serious adverse effects.     

Patient-controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial

Intravenous morphine is the treatment of choice for severe pain during vaso- occlusive crisis in sickle cell disease (SCD). However, side effects of morphine may hamper effective treatment, and high plasma levels of morphine are associated with severe complications such as acute chest syndrome. Furthermore, adequate dosing remains a problem since no objective measurement of pain severity exists and analgesia should be titrated upon the patient's reported pain. Patient-controlled analgesia (PCA) may therefore be an interesting alternative since patients can titrate the level of analgesia themselves. In this randomized controlled study, the efficacy of intravenous morphine administration with PCA was compared with continuous infusion (CI) of morphine in patients with SCD during vaso-occlusive crisis. Twenty five consecutive episodes of vaso-occlusive crisis in 19 patients with SCD were included in the study. Patients in the PCA-group had a markedly and significant lower mean and cumulative morphine consumption when compared with the patients in the CI-group (0.5 mg/hr versus 2.4 mg/hr (P < 0.001) and 33 mg versus 260 mg (P = 0.018, respectively). The mean daily pain scores were comparable (4.9 versus 5.3). The lower mean and cumulative morphine consumption in the PCA-group led to significant less nausea and constipation during treatment when compared with the CI-group (area under the curve, respectively, 11 versus 18 (P = 0.045) and 30 versus 45 (P = 0.021). Furthermore, a nonsignificant reduction in the duration of hospital admission of 3 days was observed in the PCA-group. PCA results in adequate pain relief at a much lower morphine consumption and should considered to be the first choice in morphine administration to sickle cell patients admitted with vaso-occlusive crisis.     

Association of elevated homocysteine levels with a higher risk of recurrent coronary events and mortality in patients with acute myocardial infarction

BACKGROUND: Despite the prothrombotic and proinflammatory effects associated with elevated homocysteine levels, only limited data exist regarding the effect of homocysteine levels on outcome of patients with acute myocardial infarction. METHODS: Homocysteine levels were determined within 24 hours of presentation in 157 consecutive patients with acute myocardial infarction. Patients were allocated to 2 groups: those with homocysteine levels of 2.7 mg/L (20 micro mol/L) or more (n = 22 [14%]) and those with homocysteine levels of less than 2.7 mg/L (n = 135 [86%]). RESULTS: Female and diabetic patients had significantly lower homocysteine levels than males (P<.01) and nondiabetic patients (P =.005), respectively, with no significant correlation with age (r = 0.07, P =.42) or other risk factors. Patients with homocysteine levels greater than or equal to 2.7 mg/L and less than 2.7 mg/L did not differ significantly regarding extent of coronary artery disease as reflected by prevalence of multivessel disease (54% vs 61%; P =.87), and their in-hospital course. However, in a mean +/-SD follow-up of 30 +/- 10 months, patients with homocysteine levels greater than or equal to 2.7 mg/L had a higher incidence of recurrent coronary events (36% vs 17%; P =.04) and death (18% vs 5%; P<.05). Homocysteine levels greater than or equal to 2.7 mg/L remain a significant determinant of recurrent coronary event and/or death after controlling for potential cofounders by multivariate analysis (odds ratio, 3.8; 95% confidence interval, 1.3-11.0). CONCLUSIONS: In patients with acute myocardial infarction, elevated homocysteine levels are associated with a higher risk of recurrent coronary events and death, independent of other risk factors and the extent of coronary artery disease.     

Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation

BACKGROUND: Although opioid analgesics have well-defined efficacy and safety in treatment of chronic cancer pain, further research is needed to define their role in treatment of chronic noncancer pain. OBJECTIVE: To evaluate the effects of controlled-release oxycodone (OxyContin tablets) treatment on pain and function and its safety vs placebo and in long-term use in patients with moderate to severe osteoarthritis pain. METHODS: One hundred thirty-three patients experiencing persistent osteoarthritis-related pain for at least 1 month were randomized to double-blind treatment with placebo (n = 45) or 10 mg (n = 44) or 20 mg (n = 44) of controlled-release oxycodone every 12 hours for 14 days. One hundred six patients enrolled in an open-label, 6-month extension trial; treatment for an additional 12 months was optional. RESULTS: Use of controlled-release oxycodone, 20 mg, was superior (P<.05) to placebo in reducing pain intensity and the interference of pain with mood, sleep, and enjoyment of life. During long-term treatment, the mean dose remained stable at approximately 40 mg/d after titration, and pain intensity was stable. Fifty-eight patients completed 6 months of treatment, 41 completed 12 months, and 15 completed 18 months. Common opioid side effects were reported, several of which decreased in duration as therapy continued. CONCLUSIONS: Around-the-clock controlled-release oxycodone therapy seemed to be effective and safe for patients with chronic, moderate to severe, osteo-arthritis-related pain. Effective analgesia was accompanied by a reduction in the interference of pain with mood, sleep, and enjoyment of life. Analgesia was maintained during long-term treatment, and the daily dose remained stable after titration. Typical opioid side effects were reported during short- and long-term therapy.     

Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee

OBJECTIVE: Pain is the cardinal feature of osteoarthritis (OA), and with advancing disease there is loss of function and increasing pain even at times of joint rest. Few studies have evaluated the role of opioid analgesics in treating the pain of OA. METHODS: This randomized, double blind, parallel group study compared the efficacy and safety of a 12 hourly controlled release codeine formulation (Codeine Contin) with placebo in patients with chronic pain due to OA of the hips and/or knees. The 4 week treatment period, following an analgesic washout phase of 2-7 days, included weekly clinic evaluations, at which the dose was escalated as appropriate, and daily patient diary completion. Pain (daily), stiffness, and physical function (weekly) were assessed using the multidimensional, self-administered WOMAC (visual analog scale version) questionnaire. RESULTS: Sixty-six eligible patients completed the study. The mean initial and final daily doses of controlled release codeine were 50 mg every 12 h at baseline and 159 mg every 12 h at the final assessment. All variables in the efficacy analysis indicated superiority of controlled release codeine over placebo. The WOMAC pain scale showed an improvement of 44.8% over baseline in the controlled release codeine group compared with 12.3% taking placebo (p = 0.0004). For the WOMAC stiffness and physical function scales the improvements over baseline on controlled release codeine were 47.7% and 49.3%, respectively compared with 17.0% and 17.0%, respectively, with placebo (p = 0.003; p = 0.0007). Controlled release codeine was also significantly better than placebo on measures of sleep quality and requirement for supplemental acetaminophen. CONCLUSION: Single entity controlled release codeine is an effective treatment for pain due to OA of the hip or knee.     

Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study

BACKGROUND: Although most persons with migraine treat their headaches with over-the-counter medication, systematic data on the safety and efficacy of widely used treatment, including acetaminophen, are sparse. METHODS: This is a randomized, double-blind, placebo-controlled study comparing oral acetaminophen, 1000 mg (two 500-mg Extra Strength Tylenol tablets), with identical placebo in the treatment of a single acute migraine attack. Eligible subjects met International Headache Society diagnostic criteria for migraine with or without aura. Patients who usually required bed rest with their headaches or who vomited more than 20% of the time were excluded. MAIN OUTCOME MEASURES: The percentage of subjects who, at 2 hours after dosing, experienced a change in baseline pain intensity from severe or moderate pain to mild or no pain (headache response); and pain intensity difference from baseline at the 2-hour postmedication assessment. RESULTS: The headache response rate 2 hours after dosing was 57.8% in the acetaminophen group and 38.7% in the placebo group (P =.002). Pain-free rates at 2 hours were 22.4% in the acetaminophen group and 11.3% in the placebo group (P =.01). The mean pain intensity difference from baseline 2 hours after dosing was 1.08 in the acetaminophen group and 0.73 in the placebo group (P<.001). At 2 hours, other migraine headache characteristics, such as functional disability (P =.002), photophobia (P =.02), and phonophobia (P =.08), were significantly improved after treatment with acetaminophen vs placebo. CONCLUSIONS: Acetaminophen was highly effective for treating pain, functional disability, photophobia, and phonophobia in a population-based sample of persons with migraine, excluding the most disabled persons with migraine. The drug also had an excellent safety profile and was well tolerated. Arch Intern Med. 2000;160:3486-3492.     

Glucagon vs anticholinergics in the treatment of acute pancreatitis. A double-blind controlled trial.

Sixty-two cases of acute pancreatitis, evaluated for severity according to uniform standards, were treated identically except that patients in one group received glucagon hydrochloride (group A) and those in the other oxyphenonium bromomethylate (group B). Each of the two homologous series comprise 31 patients, and mortality was the same for both groups (3/31, 10%). Statistical comparison of both series showed no significant differences in frequency of expected complications nor in fall of serum amylase levels. During treatment, serum calcium levels were significantly reduced in group A (P less than .005), and the duration of the abdominal pain was shortened (P less than .05). The volume of gastric aspirate was smaller in group B (P less than .005), and vesical catheterization proved necessary more frequently (P less than .005). Thus, similar results are obtained when glucagon or anticholinergics are employed in the treatment of acute pancreatitis, although secondary effects differ.     

The effect of low-dose intravenous ketamine on continuous intercostal analgesia following thoracotomy

Ketamine, a noncompetitive N-methyl-d-aspartate antagonist, provides analgesia and prevents chronic pain following thoracotomy. The study was aimed to assess the effect of intravenous low-dose ketamine on continuous intercostal nerve block analgesia following thoracotomy. The study was a prospective, randomized, double-blinded, and placebo-controlled clinical study, performed in a single university hospital. Sixty patients, undergoing elective lobectomy through an open posterolateral thoracotomy, were included. For postoperative pain, all patients received a continuous intercostal nerve block with bupivacaine plus intravenous paracetamol and ketoprofen. In addition, patients were randomized to have intravenous ketamine (0.1 mg/kg as a preincisional bolus followed by a continuous infusion of 0.05 mg/kg/h) in group 1 or intravenous placebo in group 2. Patients reporting a visual analog scale pain score at rest ≥40 mm received intravenous morphine sulfate as rescue analgesia. The following parameters were assessed every 6 hours for 3 postoperative days: Visual analog scale pain scores at rest and during coughing, requirement of rescue analgesia with morphine, Ramsay sedation scores and psychomimetic adverse effects. Both the groups were statistically comparable regarding visual analog scale pain scores at rest (P=0.75) and during coughing (P=0.70), number of morphine deliveries (P=0.17), cumulative dose of rescue morphine (P=0.2), sedation scores (P=0.4), and psychomimetic adverse effects (P=0.09). Intravenous low-dose ketamine, when combined with continuous intercostal nerve block, did not decrease acute pain scores and supplemental morphine consumption following thoracotomy.     

Transdermal fentanyl improves pain control and functionality in patients with osteoarthritis: an open-label Canadian trial

Current treatment guidelines advocate opioids for arthritis when standard analgesics produce inadequate relief. Efficacy, adverse effects (AEs), dosing regimens, physician expertise and patient preference influence treatment selection. This study assessed transdermal fentanyl (TDF) as a treatment option for osteoarthritis (OA) patients. This prospective, Canadian open-label, 8-week trial assessed the efficacy and safety of TDF in patients with OA of hip or knee with moderate-to-severe target joint pain inadequately controlled using weak opioids. TDF was initiated at 25 mcg/h and titrated to optimal pain control. Rescue acetaminophen 500 mg was allowed (maximum 4 g/day). The main endpoint was improvement in pain control assessment rating (five rating categories); pain intensity (0-10 numerical scale), functionality (WOMAC-OA Index), health-related quality of life (SF-36 Health Survey) and global impression were also evaluated. Eighty-one patients (61% female, mean age 60 years) were enrolled; 62 were evaluable. All had failed on previous weak opioid therapy, primarily codeine or codeine combinations. At treatment end, 65% rated pain control as improved (Pain Control Assessment rating change >or=1 category; p<0.0001); mean change in pain intensity was a reduction of greater than 2 (p<0.0001); almost 50% were maintained on TDF 25 mcg/h with less than 1.3 g/day of rescue acetaminophen. At 1 month and end of treatment, changes in the SF-36 physical global scale and individual sub-scores for the pain index and role-physical scales were highly significant (p<0.0001). Improvement in functionality was noted at 1 month and at end of treatment with significant reductions in total WOMAC score, individual pain, stiffness and physical function sub-scores (p<0.0001). AEs causing discontinuation (n=32) included nausea, dizziness and vomiting. Most treatment-related AEs were mild to moderate in intensity. TDF improved pain control, functionality and health-related quality of life in these patients. The findings support current recommendations for use of opioids such as TDF as a treatment option for a sub-population of patients with OA pain.     

Persistent nonmalignant pain and analgesic prescribing patterns in elderly nursing home residents

OBJECTIVES: To determine the prevalence of analgesics used, their prescribing patterns, and associations with particular diagnoses and medications in patients with persistent pain. DESIGN: Cross-sectional study. SETTING: Nursing homes from 10 U.S. states. PARTICIPANTS: A total of 21,380 nursing home residents aged 65 and older with persistent pain. MEASUREMENTS: Minimum Data Set (MDS) assessments on pain, analgesics, cognitive, functional, and emotional status were summarized. Logistic regression models identified diagnoses associated with different analgesic classes. RESULTS: Persistent pain as determined using the MDS was identified in 49% of residents with an average age of 83; 83% were female. Persistent pain was prevalent in patients with a history of fractures (62.9%) or surgery (63.6%) in the past 6 months. One-quarter received no analgesics. The most common analgesics were acetaminophen (37.2%), propoxyphene (18.2%), hydrocodone (6.8%), and tramadol (5.4%). Only 46.9% of all analgesics were given as standing doses. Acetaminophen was usually prescribed as needed (65.6%), at doses less than 1,300 mg per day. Nonsteroidal antiinflammatory drugs (NSAIDs) were prescribed as a standing dose more than 70% of the time, and one-third of NSAIDs were prescribed at high doses. CONCLUSION: In nursing home residents, persistent pain is highly prevalent, there is suboptimal compliance with geriatric prescribing recommendations, and acute pain may be an important contributing source of persistent pain. More effective provider education and research is needed to determine whether treatment of acute pain could prevent persistent pain.     

地佐辛复合芬太尼用于老年心脏病患者非心脏手术后镇痛效果的观察

目的:观察地佐辛复合芬太尼用于老年心脏病患者非心脏手术后镇痛效果及不良反应。方法:60例美国麻醉学家协会(ASA)II或III级择期行全麻手术合并高血压及缺血性心脏病老年患者,随机分为两组:芬太尼组(F组),芬太尼16μg/kg+盐酸托烷司琼10 mg+0.9%氯化钠液至总量100mL;芬太尼复合地佐辛组(FD组),芬太尼8μg/kg+地佐辛0.4 mg/kg+盐酸托烷司琼10 mg+0.9%氯化钠液至总量100 mL。两组患者镇痛液负荷量为5 mL,经静脉注射自控镇痛(PCIA)镇痛泵维持量2mL/h,追加量0.5 mL,锁定时间15 min。记录术后4 h、8 h、12 h、24 h、36 h及48h的视觉模拟评分(VAS)及Ramsay镇静评分、生命体征、术后各时段镇痛效果与镇痛泵按压次数及不良反应。结果:F组与FD组术后各时点VAS评分均<3分,两组间差异无统计学意义(P>0.05);F组术后8 h、12 h及24 h的Ramsay镇静评分明显高于FD组(P<0.05);镇痛期间不良反应发生率FD组低于F组(P<0.05)。结论:地佐辛复合芬太尼用于老年心脏病患者非心脏手术后镇痛治疗,其镇痛效果良好,不良反应发生率低。     

A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee

OBJECTIVE: To perform a randomized, double-blind, crossover clinical trial of diclofenac + misoprostol versus acetaminophen in ambulatory patients with osteoarthritis of the hip or knee. METHODS: Patients in 12 ambulatory care settings were eligible if they were age >40 years and if they had Kellgren/Lawrence radiographic grade 2-4 osteoarthritis of the knee or hip and a score of > or =30 mm on a 100-mm visual analog pain scale. Patients were randomized to one of two groups, 75 mg diclofenac + 200 microg misoprostol twice daily or 1,000 mg acetaminophen 4 times daily (each for 6 weeks), and were then crossed over to the other treatment for 6 weeks. A placebo was included in each treatment regimen to enable double blinding. The primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index and the visual analog pain scale of the Multidimensional Health Assessment Questionnaire. Safety was assessed using a standard form to review adverse events. RESULTS: We enrolled 227 patients, of whom 218 provided data for the first treatment period and 181 provided data for both treatment periods. Significantly higher levels of improvement in the primary outcomes were seen for diclofenac + misoprostol than for acetaminophen (P < 0.001). Adverse events were more common when patients took diclofenac + misoprostol (P = 0.046). Diclofenac + misoprostol was rated as "better" or "much better" by 57% of the 174 patients who provided such ratings for both treatment periods, while acetaminophen was rated as "better" or "much better" by 20% of these patients, and 22% reported no difference (P < 0.001). Differences favoring diclofenac + misoprostol over acetaminophen were greater in patients with more severe osteoarthritis according to baseline pain scores, radiographs, or number of involved joints. CONCLUSION: Patients with osteoarthritis of the hip or knee had significantly greater improvements in pain scores over 6 weeks with diclofenac + misoprostol than with acetaminophen, although patients with mild osteoarthritis had similar improvements with both drugs. Acetaminophen was associated with fewer adverse events.     

High dose nalbuphine in early acute myocardial infarction

Twenty patients with moderate or severe pain of suspected myocardial infarction received nalbuphine 50 mg intravenously as analgesia in 2 divided doses of 30 mg and 20 mg with 10 mg metoclopramide and were observed for 2 hours. Eighteen patients received nalbuphine outside hospital. The median time from onset of pain to treatment was 73 minutes. Within 30 minutes of the drug's administration 90% of all patients reported satisfactory pain relief (grade 0 or 1). For those with definite myocardial infarction 83% reported satisfactory pain relief at 30 minutes. There were no significant adverse cardiorespiratory effects observed or serious side-effects reported. Nalbuphine is effective and safe when used in this higher dose, although no additional analgesic effect was demonstrated when compared with lower established doses used early in acute myocardial infarction.     

Cyclobenzaprine with ibuprofen versus ibuprofen alone in acute myofascial strain: a randomized,double-blind clinical trial

STUDY OBJECTIVE: We evaluate the analgesic and side effects of adding cyclobenzaprine to ibuprofen in emergency department patients with acute myofascial strain. METHODS: A randomized, prospective, double-blind study was conducted at an urban teaching ED with an annual census of 44,000. One hundred two patients aged 18 to 70 years with acute myofascial strain caused by minor trauma within the prior 48 hours were included, and 77 patients completed the protocol. Each patient received a single dose of 800 mg of ibuprofen in the ED and a vial of 6 capsules containing 800 mg of ibuprofen to take every 8 hours as needed after discharge from the ED. In addition, 51 patients received a single dose of 10 mg of cyclobenzaprine and a vial of 6 capsules containing 10 mg of cyclobenzaprine to take every 8 hours as needed after discharge from the ED; the remaining 51 patients received an identically labeled placebo capsule and vial of placebo capsules to take every 8 hours as needed after discharge from the ED. Patients rated the intensity of their pain on a 100-mm visual analog scale (VAS) at baseline; 30, 60, 90, 120, and 180 minutes; and 24 and 48 hours after treatment. Telephone follow-up was obtained at 24 and 48 hours, and side effects were elicited at 24 and 48 hours by means of open-ended questioning. RESULTS: The patients in each group were similar with regard to diagnosis and baseline pain score. The number of patients who did not complete the protocol and the number of those who required additional analgesia were similar in both groups. Over the 48 hours of the protocol, the mean VAS score for the combination group decreased from 60.4 to 35.6, and the mean VAS score for the ibuprofen alone group decreased from 62.2 to 35.4. The mean VAS scores between groups across time was not statistically significant (P =.962, repeated-measures analysis of variance). At both 24 and 48 hours, central nervous system side effects were reported more frequently in the patients receiving cyclobenzaprine (16 [42%] versus 7 [18%] at 24 hours and 15 [39%] versus 5 [13%] at 48 hours, respectively). CONCLUSION: In ED patients with acute myofascial strain, the addition of cyclobenzaprine to ibuprofen does not improve analgesia but is associated with a greater prevalence of central nervous system side effects.