Nonopioid vs opioid analgesics after impacted third-molar extractions: The Opioid Analgesic Reduction Study randomized clinical trial

Abstract

Background: Opioids are still being prescribed to manage acute postsurgical pain. Unnecessary opioid prescriptions can lead to addiction and death, as unused tablets are easily diverted. Methods: To determine whether combination nonopioid analgesics are at least as good as opioid analgesics, a multisite, double-blind, randomized, stratified, noninferiority comparative effectiveness trial was conducted, which examined patient-centered outcomes after impacted mandibular third-molar extraction surgery. Participants were randomized to receive 5 mg of hydrocodone with 300 mg of acetaminophen (opioid) or 400 mg of ibuprofen and 500 mg of acetaminophen (nonopioid). After an initial dose, analgesic was taken every 4 through 6 hours as needed for pain. Results: In this randomized multisite clinical trial (n = 1,815 adults), those not taking opioids experienced significantly less pain (numeric rating scale ranging from 0 [no pain] through 10 [worst pain imaginable]) for first day and night (mean difference, –0.70; 95% CI, –0.94 to –0.45; P