CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,815 enrolled
Drug / intervention
opioid-containing analgesic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04452344
NCT04452344Phase 3Active

Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

Rutgers, The State University of New Jersey·interventional·Posted Jun 30, 2020·Updated Mar 31, 2026

In Brief

A Phase 3 clinical trial evaluating opioid-containing analgesic and two over-the-counter analgesics for Opioid Use. Active but no longer recruiting, targeting 1,815 participants across 5 sites.

Detailed Summary

The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.

Study Details

Timeline

Phase 3Active
202120222023202420252026
First PostedJun 30, 2020
Enrollment StartJan 4, 2021
Primary CompletionJul 7, 2023
Study CompletionJul 31, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.0 years ago

Interventions

opioid-containing analgesicdrug

hydrocodone/ acetaminophen combination product

two over-the-counter analgesicsdrug

combination of over-the-counter analgesics (ibuprofen/acetaminophen)