Actively Recruiting
Variability in Analgesic Response to Ibuprofen
Led by University of Pennsylvania · Updated on 2026-05-06
200
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, are recommended as first-line treatment for post-surgical dental pain. However, there is variability in analgesic response, and some patients require supplemental opioids for adequate pain relief. The goal of this study is to identify the factors that contribute to the need for opioid after third molar extraction to help limit unnecessary opioid prescriptions in patients who will have good pain relief with ibuprofen alone.
CONDITIONS
Official Title
Variability in Analgesic Response to Ibuprofen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Ability to take oral medication and willingness to follow the treatment regimen
- Men and women over 18 years old needing extraction of at least one impacted mandibular third molar (at least 50% covered with bone)
- No major medical problems or contraindications to surgery or study drugs
- Women of childbearing potential must use acceptable contraception during the study and have negative urine pregnancy tests at screening and surgery
- No caffeine intake within 12 hours before surgery
- Negative urine drug test at screening (except THC if use is stable and documented)
- Consume no more than 1 alcoholic drink per day on average
- Experience at least moderate pain (score ≥4 out of 10) within four hours after surgery
- Willing and able to complete safety and efficacy diaries
- Have an escort to pick up after surgery/dosing visit
You will not qualify if you...
- Pregnant or nursing women
- Use of investigational drug or experimental device within 30 days before screening, or blood donation of ≥1 pint within 8 weeks before screening
- Allergies to ibuprofen, acetaminophen, aspirin, NSAIDs, oxycodone, or other opioids (except nausea or constipation)
- Serious medical conditions that may affect safety or study results (e.g., uncontrolled hypertension, diabetes, bleeding disorders, severe organ dysfunction)
- Acute local infection at surgery time
- Use of confounding medications or substances within 24 hours before surgery (analgesics, sedating antihistamines, sedatives, alcohol, CNS agents)
- Abnormal lab values or physical findings impacting safety or interpretation
- History of opioid or other substance use disorder
- Unwillingness to provide blood sample for genetic testing
- Employees or relatives of study investigators involved in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Stacey Secreto
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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