DOUBLE-BLIND, SINGLE-DOSE COMPARISON OF BROMFENAC SODIUM, TRAMADOL, AND PLACEBO AFTER ORAL-SURGERY

This double-blind, parallel-group study was performed at a single site in patients with moderate or severe pain after oral surgery to remove one or more impacted third molars. Patients recorded their pain inten sity at baseline and were then assigned to receive a single dose of br omfenac sodium (25 mg or 50 mg), tramadol (100 mg), or placebo, using a randomized double-blind code. At regular intervals for up to 8 hours after study drug administration, pain intensity and pain relief were recorded and were used to derive the efficacy variables, total pain re lief (TOTPAR), pain intensity difference (PID), and summed pain intens ity difference (SPID). Both doses of bromfenac were superior to tramad ol and placebo in terms of hourly and peak pain relief-and PID. The S- hour and 8-hour TOTPAR and SPID results for both doses of bromfenac al so were significantly superior to those for tramadol and placebo, wher eas the scores for tramadol did not show superiority to placebo. Simil arly, both doses of bromfenac were superior to tramadol and placebo as measured by patient global assessment, time to meaningful pain relief , and duration of pain relief. Bromfenac was well tolerated and was eq uivalent to placebo with respect to treatment-emergent study events. O verall, significantly more study events (total), digestive events (par ticularly nausea and vomiting), and nervous system events (particularl y dizziness) occurred in patients treated with tramadol than in those in other treatment groups. Single oral doses of bromfenac were more ef fective, longer-acting and better tolerated than single doses of trama dol in providing pain relief after oral surgery. (C) 1998 The American College of Clinical Pharmacology.