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 intensity at baseline and were then assigned to receive a single dose of bromfenac 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 relief (TOTPAR), pain intensity difference (PID), and summed pain intensity difference (SPID). Both doses of bromfenac were superior to tramadol and placebo in terms of hourly and peak pain relief and PID. The 3-hour and 8-hour TOTPAR and SPID results for both doses of bromfenac also were significantly superior to those for tramadol and placebo, whereas the scores for tramadol did not show superiority to placebo. Similarly, 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 equivalent to placebo with respect to treatment-emergent study events. Overall, significantly more study events (total), digestive events (particularly nausea and vomiting), and nervous system events (particularly dizziness) occurred in patients treated with tramadol than in those in other treatment groups. Single oral doses of bromfenac were more effective, longer-acting, and better tolerated than single doses of tramadol in providing pain relief after oral surgery.