Variability in Analgesic Response to Ibuprofen

Exclusion Criteria

• •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.