The journal of pain : official journal of the American Pain Society
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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
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.