Opioid Analgesic Reduction Study (OARS)

Rutgers The State University of New Jersey

Status and phase: Active, not recruiting; Phase 3

Conditions: Opioid Use

Treatments: Drug: opioid-containing analgesic; Drug: two over-the-counter analgesics

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04452344

Pro2020002299

5UH3DE028860-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,815 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

An individual must meet all of the following criteria to be eligible to participate in the study:

• Be able to understand the informed consent.

• Provide signed and dated informed consent form

• Be able to understand all directions for data gathering instruments in English

• Be willing and able to comply with all study procedures and be available for the duration of the study

• Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars

• Be 18 years or older

• Be in good general health as evidenced by medical history

• Women must agree to use one of the following methods of contraception while participating in this study:

  • contraceptive pill
  • intra-uterine device
  • condoms
  • abstinence

Exclusion criteria

Participants who self-report the following history will be excluded from participating:

• History of gastrointestinal bleeding and/or peptic ulcer

• History of renal disease (excluding kidney stones)

• History of hepatic disease

• History of bleeding disorder

• History of respiratory depression

• Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively

• Active or untreated asthma

• History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia

• Currently taking any of the following medications:

  • CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
  • CNS depressants.

• Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism

• History of drug or alcohol abuse

• Family history of drug or alcohol abuse in a first-degree relative

• Has had no more than one opioid prescription filled within the past 12 months

• Currently pregnant or lactating

Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

• Prior participation in this study
• Inability or refusal to provide informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,815 participants in 2 patient groups

Opioid

Active Comparator group

Description:

Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.

Treatment:

Drug: opioid-containing analgesic

Non-Opioid

Active Comparator group

Description:

Combination of ibuprofen 400 mg/acetaminophen 500 mg

Treatment:

Drug: two over-the-counter analgesics