The journal of pain : official journal of the American Pain Society
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A randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo. At the 2- and 4-week visits, the primary outcome measure, visual analog scale (VAS) for pain, and the secondary outcome measures, number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ), were evaluated. After a 4-week washout period, subjects returned for reassessment of the outcome measures. There were no significant differences in population demographics between groups at baseline. There were significant decreases in the VAS (-2.04, P < .02), FIQ (-12.07, P < .02), and anxiety (-1.67, P < .02) in the nabilone treated group at 4 weeks. There were no significant improvements in the placebo group. The treatment group experienced more side effects per person at 2 and 4 weeks (1.58, P < .02 and 1.54, P < .05), respectively. Nabilone appears to be a beneficial, well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement. ⋯ To our knowledge, this is the first randomized, controlled trial to assess the benefit of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement in patients with fibromyalgia. As nabilone improved symptoms and was well-tolerated, it may be a useful adjunct for pain management in fibromyalgia.
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Randomized Controlled Trial
Effects of a selective cyclooxygenase-2 inhibitor on postoperative inflammatory reaction and pain after total knee replacement.
The goal of this study was to evaluate the systemic and peripheral effects of preoperative administration of cyclooxygenase-2 inhibitor on pain and inflammation occurring with total knee replacement (TKR). Patients undergoing elective TKR were prospectively and randomly given oral rofecoxib (25 mg) or placebo (control group) 1 hour before surgery. All patients received an epidural combined with isoflurane anesthesia during the operation and patient-controlled epidural analgesia postoperatively. The outcome measures included pain scores during rest and movement of knee joints and cumulative morphine consumption. Femoral blood and knee joint drainage fluids were examined for leucocyte numbers and concentrations of cytokines (including IL-6, IL-8, IL-10, and TNF-alpha). Periarticular circumferential increments at 48 hours served as an indication of inflammatory edema. Pain scores during rest and knee joint movement on postoperative days 1 and 2 were better in those given rofecoxib than in control subjects, and cumulative morphine consumption for the first 24 hours was significantly reduced. Both groups had higher concentrations of IL-6 and IL-8 in knee drainage fluid compared with serum levels. Rofecoxib significantly decreased regional IL-6 and TNF-alpha level after surgery. Moreover, the incidence of febris and degree of local edema were lower in the rofecoxib group (P < .05), and peripheral IL-6 level significantly correlated with pain score at 48 hours. Preoperative administration of rofecoxib increases patient satisfaction with analgesia, reduces opioid requirement, and decreases both systemic and local anti-inflammation after TKR. ⋯ This randomized, double-blinded trial shows that preoperative administration of rofecoxib can greatly ameliorate the pain occurring with total knee joint replacement surgery and its accompanying reduction of general and local inflammatory reactions.
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Randomized Controlled Trial Comparative Study
Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial.
This randomized, double-blinded, double-dummy, parallel-group, single-center study compared a single dose of the novel selective COX-2 inhibitor lumiracoxib (400 mg), with celecoxib (400 mg) or placebo in dental pain. Patients > or =17 years with moderate-to-severe dental pain were recruited after surgical extraction of 2 or more partially or fully bony impacted molars. Pain intensity was measured using the categorical scale and the primary efficacy variable was the summed pain intensity difference over 8 hours after dosing (SPID-8). Patient disposition and demographics were comparable between lumiracoxib 400 mg (n = 156), celecoxib 400 mg (n = 156), and placebo (n = 52) groups. Lumiracoxib was statistically superior (P < .001) to both celecoxib and placebo in reducing pain intensity (SPID-8; least-squares means: 8.31, lumiracoxib; 4.26, celecoxib; -1.87, placebo). Significantly more patients treated with lumiracoxib (58.9%) considered treatment to be good or excellent compared with celecoxib and placebo (42.3% and 5.7%, respectively; P = .001). Lumiracoxib was superior to celecoxib and placebo for all other secondary efficacy variables. All treatments were well-tolerated. In conclusion, 400 mg lumiracoxib was well-tolerated and provided significantly superior analgesia to 400 mg celecoxib or placebo in patients with moderate-to-severe pain after dental surgery. ⋯ In a randomized, double-blinded, double-dummy, parallel-group, single-center study, a single dose of the novel selective COX-2 inhibitor lumiracoxib (400 mg) was well-tolerated and provided significantly superior analgesia to 400 mg celecoxib or placebo in patients with moderate-to-severe dental pain after surgical extraction of impacted molars.
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Randomized Controlled Trial Comparative Study
Epidural labor analgesia: continuous infusion versus patient-controlled epidural analgesia with background infusion versus without a background infusion.
The purpose of this study was to compare the total epidural dose of 3 commonly used labor epidural modalities. After local institutional review board approval, 195 laboring parturients received an epidural catheter for labor analgesia. All patients received an initial bolus of 0.1% ropivacaine (10 mL) and fentanyl (100 microg). Maintenance of labor analgesia consisted of ropivacaine 0.1% with fentanyl 2 microg/mL. Patients were then randomly assigned into 3 groups: Group 1 (continuous epidural infusion [CEI]), continuous infusion at 10 mL/h; group 2 (CEI + patient-controlled epidural analgesia [PCEA]), CEI at 5 mL/h with a demand dose of 5 mL allowed every 20 minutes with a 20 mL/h maximum dose; group 3 (PCEA), demand doses only of 5 mL every 15 minutes with a 20 mL/h maximum dose. Measured variables included total epidural dose, total bolus requests and boluses delivered, number of staff interventions, pain Visual Analog Scale (VAS; 0-100), modified Bromage scores, stage I and II labor duration, delivery outcome, and maternal satisfaction after delivery. No differences were noted with respect to pain VAS, modified Bromage scores, stage I and II labor duration, number of staff interventions, delivery outcome, and maternal satisfaction score. Total infusion dose was lower in demand dose only PCEA compared with CEI and CEI + PCEA groups (P = < .01). Demand dose-only PCEA results in less total epidural dose compared with CEI and CEI + PCEA without affecting labor duration, motor block, pain VAS, maternal and neonatal outcomes, and maternal satisfaction. ⋯ This article compares 3 commonly used labor epidural delivery modalities (traditional continuous epidural infusion, patient-controlled epidural analgesia with a background infusion, and demand dose-only patient-controlled epidural analgesia). Benefits in epidural dose reduction with demand dose only PCEA does not translate into improved maternal and neonatal outcome.
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Randomized Controlled Trial Clinical Trial
A randomized clinical trial of targeted cognitive behavioral treatment to reduce catastrophizing in chronic headache sufferers.
This randomized clinical trial (RCT) examined the efficacy of a cognitive-behavioral treatment (CBT) specifically targeted toward reducing pain catastrophizing for persons with chronic headache. Immediate treatment groups were compared with wait-list control groups. Differential treatment gains based on the order of presentation of 2 components of CBT (cognitive restructuring and cognitive/behavioral coping) and the role of catastrophizing in treatment outcome were examined. Thirty-four participants enrolled in a 10-week group treatment and 11 completed a wait-list self-monitoring period. Participants reported significant reductions in catastrophizing and anxiety and increased self-efficacy compared with wait-list control subjects, and these were maintained at follow-up. Although we did not find overall differences in the reduction of headache frequency or intensity compared with wait-list control subjects, calculation of clinical significance on headache indicators suggest that approximately 50% of treated participants showed meaningful changes in headache indices as well. Order of treatment modules was not related to gains during treatment or at follow-up; however, almost all changes occurred during the second half of treatment, suggesting that duration of treatment participation is important. ⋯ Cognitive-behavioral treatment targeting reduction of catastrophizing for chronic headache pain reduced negative cognitive and affective variables associated with recurrent headache, increased headache management self-efficacy, and in half of the participants, produced clinically meaningful reductions in headache indicators. Length of treatment is an important factor to consider when providing CBT for chronic pain.