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

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.

SUBMITTER: Kellstein D 

PROVIDER: S-EPMC7419400 | BioStudies | 2020-01-01

REPOSITORIES: biostudies

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