Study tests if common painkillers can replace opioids after surgery
NCT ID NCT04452344
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study looks at whether a combination of over-the-counter pain relievers (like ibuprofen and acetaminophen) can control pain after wisdom tooth removal just as well as, or better than, prescription opioids. About 1,800 people having their wisdom teeth removed will be randomly assigned to receive either the non-opioid combo or a standard opioid. The goal is to find safer ways to manage acute post-surgical pain and reduce opioid use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,815 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rutgers School of Dental Medicine
Newark, New Jersey, 07101, United States
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University of Illinois at Chicago
Chicago, Illinois, 60612, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Rochester
Rochester, New York, 14620, United States
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Other studies related to the condition(s) this trial covers.
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