Opioid Analgesic Reduction Study (OARS) - Pilot

Completed · Phase 3

Conditions studied: Post Operative Pain

In brief

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.

Key facts

Study ID

NCT05283499

Run by

Rutgers, The State University of New Jersey

People needed

53

Starts

2020-07-06

Expected to finish

2021-03-26

Last updated by the study team

2023-06-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Illinois Chicago — Chicago, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Rutgers University — Newark, New Jersey, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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