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

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 < .001) and second day and night (mean difference, -0.28; 95% CI, -0.52 to -0.04; P = .015), and experienced no more pain than participants taking opioids over the entire postoperative period (mean difference, -0.20; 98.75% CI, -0.45 to 0.05; P = .172). Participants not taking opioids had higher overall satisfaction at the postoperative visit (85.3% extremely satisfied or satisfied vs 78.9%; 95% CI, 1.21 to 1.98; P = .006).

CONCLUSIONS

The ibuprofen and acetaminophen combination managed pain better for the first 2 days and led to greater satisfaction over the entire postoperative period than hydrocodone with acetaminophen. At no time did hydrocodone outperform the nonopioid.

PRACTICAL IMPLICATIONS: Routine opioid prescribing after dental surgery is not supported. The results of this study confirmed the American Dental Association's recommendations that ibuprofen and acetaminophen in combination should be the first-line therapy for acute pain management. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT04452344.