NCT04452344

Opioid Analgesic Reduction Study

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,815 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Use

Interventions

Type	Name	Description
DRUG	opioid-containing analgesic	hydrocodone/ acetaminophen combination product
DRUG	two over-the-counter analgesics	combination of over-the-counter analgesics (ibuprofen/acetaminophen)

Timeline

• Start date: 2021-01-04
• Primary completion: 2023-07-07
• Completion: 2026-07-31
• First posted: 2020-06-30
• Last updated: 2026-03-31
• Results posted: 2024-07-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study