Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study

Abstract

Abstract Introduction Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug–drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety. Objectives The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo. Methods This 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4]0–8). Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs) were also assessed. Results In total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4]0–8 (all p 720 min; all p 9 h, and tolerability similar to that with ibuprofen and placebo. ClinicalTrials.gov Registration NCT01559259