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ACTIVE NOT RECRUITING
NCT04452344
PHASE3

Opioid Analgesic Reduction Study

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1815

Start Date

2021-01-04

Completion Date

2026-07-31

Last Updated

2026-03-31

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

opioid-containing analgesic

hydrocodone/ acetaminophen combination product

DRUG

two over-the-counter analgesics

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

Locations (5)

University of Illinois at Chicago

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Rutgers School of Dental Medicine

Newark, New Jersey, United States

University of Rochester

Rochester, New York, United States