Opioid Analgesic Reduction Study (OARS)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-03-26

Brief Summary

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The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

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Detailed Description

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A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules

Study Groups

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Opioid

Combination analgesic of hydrocodone 5mg/acetaminophen350 mg

Group Type ACTIVE_COMPARATOR

OPIOID

Intervention Type DRUG

Analgesic assignment

Non-Opioid

Combination analgesic of ibuprofen 400mgacademinophen 350mg

Group Type ACTIVE_COMPARATOR

NON-OPIOID

Intervention Type DRUG

Analgesic assignment

Interventions

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OPIOID

Analgesic assignment

Intervention Type DRUG

NON-OPIOID

Analgesic assignment

Intervention Type DRUG

Other Intervention Names

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Opioid containing analgesic Non-opioid contains analgesic

Eligibility Criteria

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Inclusion Criteria

* Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
* Subjects who are English speaking and are able to provide consent will be considered.
* Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

Exclusion Criteria

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

* Individual under the age of 18
* 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 drug that required respiratory support postoperatively
* Active or untreated asthma
* History of known allergic 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 (excludes marijuana use)
* Family history of drug or alcohol abuse in a first degree relative
* Has had one or more opioid prescription filled within the past 6 months
* Currently pregnant or lactating

Patients 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

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes