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Opioid Analgesic Reduction Study

NCT04452344 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1815

Last updated 2026-03-31

Study results available
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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

DRUG

opioid-containing analgesic

hydrocodone/ acetaminophen combination product

DRUG

two over-the-counter analgesics

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

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Rochester

    collaborator OTHER

  • University of Maryland, Baltimore

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Cecile A Feldman, DMD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2023-07-07
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452344 on ClinicalTrials.gov