Variability in Analgesic Response to Ibuprofen

NCT06539741 | Recruiting

• 2 other identifiers: 8563671R01DE033405-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pain, Acute; Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Supplemental Opioid Use

  Use of oxycodone in addition to ibuprofen + acetaminophen

  Up to 7 days after third molar extraction

Secondary Outcomes (7)

• Gene Expression Profiling

  Up to 7 days after third molar extraction

• COX-1 activity

  Up to 7 days after third molar extraction

• COX-2 activity

  Up to 7 days after third molar extraction

• DNA sequencing

  1 day

• Pain intensity score

  Up to 7 days after third molar extraction

Study Arms (2)

Complete Responders

Patients who do not require supplemental opioids, in addition to a standard-of-care NSAID-based pain management regimen, for pain relief following third molar extraction

Partial Responders

Patients who require supplemental opioids (oxycodone 5 mg), in addition to a standard-of-care NSAID-based pain management regimen, for pain relief following third molar extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting for surgical extraction of partial or full bony impacted mandibular third molars at the Oral Surgery Clinics at Penn Dental Medicine

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to take oral medication and be willing to adhere to the study treatment regimen
• Men and women greater than 18 years of age requiring extraction of at least one impacted mandibular third molar tooth (at least 50% covered with bone).
• Absence of other major medical problems or contraindications to surgery or study drugs.
• Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and a urine pregnancy test on the day of surgery, which must be negative at all time points.
• Has not ingested caffeine-containing products within 12 hours of surgery.
• All subjects must consent to a urine drug test at screening. Results must be negative (except for THC) unless the subject is on a stable dose of a non-analgesic drug for a legitimate medical purpose. A positive test for THC will be permitted and the frequency of use will be documented. A positive result will be reported to the subject.
• Does not consume more than 1 alcoholic beverage per day on average.
• Subjects must reach a level of at least moderate pain within four hours of surgery completion, with a pain score greater than or equal to 4 on a 0-10 numerical pain scale
• Subjects must be willing and able to complete safety and efficacy diaries.
• An escort must be available to pick up the subject at the end of at the end of the surgical/dosing visit (Visit #2).

You may not qualify if:

• Female subjects who are pregnant or nursing a child.
• Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
• Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components.
• Subjects who are sensitive or allergic to aspirin or other NSAIDs.
• Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation).
• Presence of a serious medical condition (e.g. poorly controlled hypertension or diabetes, gastrointestinal disorders such as bleeding ulcer, coagulation or bleeding disorders, significantly impaired cardiac, renal, hepatic, respiratory, or thyroid function) that according to the investigator may interfere with interpretation of the study results or compromise the safety of a potential subject.
• Acute local infection at the time of surgery that could confound post-surgical evaluation.
• Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
• Subjects who have a history of opioid use disorder or other substance use disorder, based upon history and judgment of the Investigator.
• Subjects who are unwilling to provide a blood sample for genetic analyses.
• Employees of the principal investigator, sub-investigators, or relative of an employee who is directly involved in this study.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, whole blood, peripheral blood mononuclear cells, stool, oral microbiome, tissue

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine N Theken, PharmD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Secreto

CONTACT

215-746-8871; secreto@upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)