Comparison of rofecoxib and celecoxib, two cyclooxygenase-2 inhibitors, inpostoperative dental pain: A randomized, placebo- and active-comparator-controlled clinical trial

Pain is a common complaint, often occurring in conjunction with inflammatio n. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used analgesic agents in ambulatory patients. In recent studies, the cyclooxyge nase-2 (COX-2) inhibitor rofecoxib demonstrated analgesic effects similar t o those of NSAIDs in the treatment of acute pain and primary dysmenorrhea. The present randomized, single-dose, double-blind, double-dummy, placebo- a nd active-comparator-controlled, parallel-group study was undertaken to com pare the analgesic efficacy of the COX-2 inhibitors rofecoxib 50 mg and cel ecoxib 200 mg with that of ibuprofen 400 mg and placebo in patients with po stoperative dental pain. Two hundred and seventy-two patients experiencing pain after the removal of greater than or equal to 2 third molars were rand omized according to pain severity (moderate vs severe) to receive a single dose of placebo (n = 45), rofecoxib 50 mg (n = 90), celecoxib 200 mg (n = 9 1), or ibuprofen 400 mg (n = 46). Using a patient diary, patients recorded pain intensity, pain relief, and global evaluations throughout the 24-hour period after dosing. The overall analgesic effect, onset of action, peak ef fect, and duration of effect were evaluated, with the primary end point bei ng total pain relief over 8 hours (TOPAR8). The safety profile was assessed on the basis of physical findings, laboratory results, and spontaneous rep orts of adverse experiences. The results showed that compared with celecoxi b, rofecoxib had superior analgesic effects on all measures of analgesic ef ficacy, including overall analgesic effect (TOPAR8, 18.3 vs 12.5; P < 0.001 ), time to onset of effect (30 vs 60 minutes; P = 0.003), peak pain relief (score, 2.8 vs 2.3; P < 0.05), and duration of effect (> 24 vs 5.1 hours; P < 0.001). In addition, rofecoxib's analgesic efficacy was similar to that of ibuprofen (TOPAR8, 18.3 vs 17.0; P = 0.460), but the duration was longer (P < 0.05); with ibuprofen, the time to onset was 24 minutes, peak pain re lief score was 2.9, and duration of analgesic effect was 8.9 hours. The saf ety profile was similar across all treatment groups. Thus rofecoxib provide d analgesic efficacy superior to that of celecoxib and comparable to that o f ibuprofen in the treatment of patients with acute postoperative dental pa in. .