SINGLE-DOSE AND MULTIDOSE ANALGESIC STUDY OF IBUPROFEN AND MECLOFENAMATE-SODIUM AFTER 3RD MOLAR SURGERY

The purpose of this study was to compare the analgesic efficacy and sa fety of meclofenamate sodium with ibuprofen after dental impaction sur gery. This study was double-blind and used a unique methodology. Patie nts (N = 254) were first randomized into the single dose phase of the study that included placebo, meclofenamate 50 mg, meclofenamate 100 mg , ibuprofen 200 mg, and ibuprofen 400 mg, followed by a 7-day multidos e phase in which patients in the placebo group were rerandomized into one of the active treatment cells. In the single dose phase, all activ e treatments were significantly more efficacious than placebo for ever y summary analgesic measure. A positive dose-response was seen for bot h active drugs with meclofenamate 100 mg and ibuprofen 400 mg exhibiti ng the greatest efficacy for pain relief, pain reduction, time to reme dication, and overall evaluation. Side effects were reported by 26 pat ients. They were evenly distributed among treatment groups with headac he and drowsiness being the most common. During the multidose phase, t here were only small differences in efficacy measures among active tre atment groups. However, meclofenamate produced a higher incidence of s tomach cramps and diarrhea than did ibuprofen (8.8% and 7.2% versus 0. 8% and 0.8%). This study indicates that higher doses of nonsteroidal a nti-inflammatory drugs are most effective immediately after surgery an d that lower doses of these drugs can be used after the first postoper ative day. The side effect profile of nonsteroidal anti-inflammatory a nalgesics is best observed with the use of a multidose study design.