Opioid Analgesic Reduction Study

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1815 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This study was a double-blinded study. The participant, care provider, site directors and site research coordinators were all blinded.

Study Groups

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Opioid

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

Group Type ACTIVE_COMPARATOR

opioid-containing analgesic

Intervention Type DRUG

hydrocodone/ acetaminophen combination product

Non-Opioid

Combination of ibuprofen 400 mg/acetaminophen 500 mg

Group Type ACTIVE_COMPARATOR

two over-the-counter analgesics

Intervention Type DRUG

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

Interventions

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opioid-containing analgesic

hydrocodone/ acetaminophen combination product

Intervention Type DRUG

two over-the-counter analgesics

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes