Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib inpost-dental surgery pain: A randomized, controlled trial

Previous data have suggested that rofecoxib, a cyclooxygenase (COX)-2-speci fic inhibitor, had analgesic effects similar to those of the nonsteroidal a nti-inflammatory drugs when tested in the post-dental surgery pain model. T he objective of this parallel-group, double-masked, randomized, placebo and active comparator-controlled clinical trial was to assess more fully the a nalgesic efficacy of rofecoxib in the treatment of postoperative dental pai n. After dental surgery, 151 patients (50.3% women; mean age, 18.3 years; 9 3.4% white) experiencing moderate-to-severe pain were to receive a single d ose of placebo. rofecoxib 50 mg, or ibuprofen 400 mg. Analgesic efficacy wa s assessed for up to 24 hours postdose using self-administered questionnair es. Tolerability was assessed using spontaneous reports of adverse experien ces, physical findings, and laboratory measurements. The results of this st udy demonstrated that rofecoxib 50 mg was more effective than placebo on al l measures of analgesic efficacy. Rofecoxib 50 mg exhibited overall analges ic effects, onset of analgesia, and peak analgesic effects that were not si gnificantly different from those of ibuprofen 400 mg, with a significantly longer duration of action (P < 0.05). We concluded that rofecoxib was effic acious in the treatment of postoperative dental pain and that COX-2-derived prostanoids play a role in treatment of the pain associated with dental su rgery.