RECRUITING

Variability in Analgesic Response to Ibuprofen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms of Variability in the Analgesic Response to Ibuprofen Following Third Molar Extraction

Quick Facts

Study Start:2025-01

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06539741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Ability to take oral medication and be willing to adhere to the study treatment regimen 4. 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). 5. Absence of other major medical problems or contraindications to surgery or study drugs. 6. 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. 7. Has not ingested caffeine-containing products within 12 hours of surgery. 8. 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. 9. Does not consume more than 1 alcoholic beverage per day on average. 10. 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 11. Subjects must be willing and able to complete safety and efficacy diaries. 12. An escort must be available to pick up the subject at the end of at the end of the surgical/dosing visit (Visit #2).	1. Female subjects who are pregnant or nursing a child. 2. 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. 3. Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components. 4. Subjects who are sensitive or allergic to aspirin or other NSAIDs. 5. Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation). 6. 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. 7. Acute local infection at the time of surgery that could confound post-surgical evaluation. 8. Use of any confounding prescription or non-prescription drug within 24 hours of the surgical procedure, including analgesics, sedating antihistamine, sedative, alcohol, or CNS/psychotropic agents (i.e. sleep aids, benzodiazepines). Hormonal contraceptives, hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), or thyroid replacement hormones are allowed. Individuals taking other/additional chronic stable medications can be considered on a case-by-case basis for inclusion in the study if agreed upon by judgment of the investigator. 9. 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. 10. Subjects who have a history of opioid use disorder or other substance use disorder, based upon history and judgment of the Investigator. 11. Subjects who are unwilling to provide a blood sample for genetic analyses. 12. Employees of the principal investigator, sub-investigators, or relative of an employee who is directly involved in this study.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Ability to take oral medication and be willing to adhere to the study treatment regimen
4. 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).
5. Absence of other major medical problems or contraindications to surgery or study drugs.
6. 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.
7. Has not ingested caffeine-containing products within 12 hours of surgery.
8. 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.
9. Does not consume more than 1 alcoholic beverage per day on average.
10. 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
11. Subjects must be willing and able to complete safety and efficacy diaries.
12. An escort must be available to pick up the subject at the end of at the end of the surgical/dosing visit (Visit #2).

1. Female subjects who are pregnant or nursing a child.
2. 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.
3. Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components.
4. Subjects who are sensitive or allergic to aspirin or other NSAIDs.
5. Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation).
6. 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.
7. Acute local infection at the time of surgery that could confound post-surgical evaluation.
8. Use of any confounding prescription or non-prescription drug within 24 hours of the surgical procedure, including analgesics, sedating antihistamine, sedative, alcohol, or CNS/psychotropic agents (i.e. sleep aids, benzodiazepines). Hormonal contraceptives, hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), or thyroid replacement hormones are allowed. Individuals taking other/additional chronic stable medications can be considered on a case-by-case basis for inclusion in the study if agreed upon by judgment of the investigator.
9. 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.
10. Subjects who have a history of opioid use disorder or other substance use disorder, based upon history and judgment of the Investigator.
11. Subjects who are unwilling to provide a blood sample for genetic analyses.
12. Employees of the principal investigator, sub-investigators, or relative of an employee who is directly involved in this study.

Contacts and Locations

Study Contact

Stacey Secreto

CONTACT

215-746-8871

secreto@upenn.edu

Principal Investigator

Katherine N Theken, PharmD, PhD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Katherine N Theken, PharmD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-01

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Impacted Third Molar Tooth
Pain, Acute