Abstract

The purpose of the study was to compare the preemptive analgesic effect of celecoxib, a cyclooxygenase 2 inhibitor, with a traditional nonsteroidal anti-inflammatory drug, ibuprofen, in patients after minor oral surgery procedures. This randomized, double-blind, placebo-controlled, prospective clinical trial was conducted over an 8-month period. Participants were randomly allocated to receive a standard oral dose of 200 mg celecoxib, 400 mg ibuprofen, or a placebo containing lactose, preemptively 1 h before surgery. 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 effect, and duration of effect were evaluated, with the primary end point being total pain relief over 8 hours. The safety profile was assessed on the basis of physical findings and spontaneous reports of adverse experiences. The results showed that compared with ibuprofen, celecoxib had superior analgesic effects on all measures of analgesic efficacy, including overall analgesic effect (total pain relief over 8 hours: 18.1 vs 12.2, P < 0.001), time to onset of effect (30 vs 60 minutes, P = 0.003), peak pain relief (score, 2.7 vs 2.4, P < 0.05), and duration of effect (>24 vs 7.0 hours, P < 0.001). The safety profile was similar across all treatment groups. This is the first reported study that demonstrates the superior analgesic effect of celecoxib, for the release of acute postoperative pain following surgery, when compared with the traditional nonsteroidal anti-inflammatory drug, ibuprofen. There was no safety compromise when celecoxib was used in lower doses to provide analgesia for patients who need minor surgery.

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