Active — Not RecruitingPhase 3

Opioid Analgesic Reduction Study

United States1,815 participantsStarted 2021-01-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite Pain 1

Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)

Composite Pain 2

Timeframe: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)

Composite Pain 3

Timeframe: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)

Composite Pain All

Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)

Overall Satisfaction

Timeframe: At time of post-operative visit (day 9 +/- 5 days)

Pain Worst 1

Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)

Pain Worst 2

Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery

Trial details

NCT IDNCT04452344

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-07

Results submitted2024-05-15

View on ClinicalTrials.gov More Opioid Use trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Composite Pain 1

Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)

Composite Pain 2

Timeframe: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)

Composite Pain 3

Timeframe: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)

Composite Pain All

Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)

Overall Satisfaction

Timeframe: At time of post-operative visit (day 9 +/- 5 days)

Pain Worst 1

Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)

Pain Worst 2

Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery