Double-masked, single-dose comparison of bromfenac sodium, acetaminophen plus oxycodone, and placebo after oral surgery

Abstract

In this double-masked, parallel-group study, patients with moderate or severe pain after surgical removal of one or more impacted third molars were randomly assigned to receive a single dose of bromfenac 25 mg or 50 mg, acetaminophen 650 mg plus oxycodone 10 mg (APOX), or placebo. Patients reported their pain intensity at baseline and at regular intervals for up to 8 hours after receiving the study medication. The following efficacy measurements were collected or derived from patient assessments: hourly pain relief, peak pain relief, total pain relief (TOPAR), hourly pain intensity difference (PID), peak PID, and summed PID (SPID). Bromfenac 25 mg or 50 mg and APOX were significantly superior to placebo for each efficacy variable. The three active drug treatments were comparable up to 3 hours after administration: bromfenac 25 mg was significantly better than APOX at hour 4, and bromfenac 50 mg was superior to APOX for all hourly variables at hours 4 to 8. Mean 8-hour TOPAR and SPID scores demonstrated that bromfenac 25 mg was at least as effective as APOX, whereas bromfenac 50 mg was significantly superior to APOX. As compared with APOX or placebo, significantly more bromfenac-treated patients had global assessments of excellent or very good. Bromfenac was well-tolerated and comparable to placebo with respect to treatment-emergent study events (adverse events that either appeared or worsened after administration of the study drug). In contrast, APOX produced significantly more study events than bromfenac or placebo, including digestive events (eg, nausea or vomiting) and nervous system events (eg, dizziness or somnolence). These results demonstrate that single oral doses of bromfenac were at least as effective as APOX in providing pain relief after oral surgery. Bromfenac produced a longer duration of analgesic action than APOX, with a comparable short time to onset of action.