CLINICAL TRIAL
CLINICAL TRIAL, PHASE IV
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Efficacy of preoperative oral rofecoxib in pain control for third molar surgery.

OBJECTIVE: The study compared the analgesic efficacy of preoperative 50 mg oral rofecoxib, 400 mg ibuprofen, and placebo in the control of postoperative pain after third molar surgery.

STUDY DESIGN: This was a clinical randomized, double-blind, cross-over, placebo- and active-comparator-controlled study. The surgeries were randomized into 3 groups, in which patients were given a single dose of 50 mg rofecoxib, 400 mg ibuprofen, or placebo 30-60 minutes before the surgery. The patients were asked to quantify their pain intensity basing on a visual analog scale postoperatively. A rescue medication, 500 mg acetaminophen, was prescribed to the patients. The quantity and time of consumption of the rescue tablets were recorded by the patients.

RESULTS: A total of 49 patients completed the study. Of the 98 lower third molar extractions 33 were with rofecoxib, 33 ibuprofen, and 32 placebo. The pain scores within the first 6 hours postoperatively in the rofecoxib group were significantly lower than the placebo ( P < .05). The ibuprofen group did not have significantly lower pain scores than the placebo group. Regarding the postoperative requirement of rescue medication, the rofecoxib group required significantly less rescue medication than both ibuprofen and placebo groups in the first twelve hours after the surgery.

CONCLUSIONS: The preoperative oral intake of 50 mg rofecoxib provides a significantly better analgesic benefit than the placebo for postoperative pain relief in the first 6 hours after third molar surgery. This regimen also reduced the requirement of postoperative analgesic when compared with ibuprofen and placebo in the first 12 postoperative hours.

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