Variability in Analgesic Response to Ibuprofen
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Patients presenting for surgical extraction of partial or full bony impacted mandibular third molars at the Oral Surgery Clinics at Penn Dental Medicine
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Complete Responders
Group B: Partial Responders
Trial outcomes
Primary outcomes
1
Supplemental Opioid Use
Use of oxycodone in addition to ibuprofen + acetaminophen
Time frame
Up to 7 days after third molar extractionSecondary outcomes
1
Gene Expression Profiling
mRNA levels will be measured in peripheral blood mononuclear cells
Time frame
Up to 7 days after third molar extraction2
COX-1 activity
COX-1 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine.
Time frame
Up to 7 days after third molar extraction3
COX-2 activity
COX-2 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine.
Time frame
Up to 7 days after third molar extraction4
DNA sequencing
Assessment of genetic variation
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov