Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Condition: Pain
MeSH terms: Toothache
Intervention: Pharmacogenomic Testing; Ibuprofen; hydroxycontin/acetominophen; acetominophen; Oxycontin/acetominophen
Intervention description: Saliva collection (5mL); 400 mg; hydroxycontin 2.5 mg, acetominophen 325 mg; 650 mg; 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Opioid analgesics are the most common postoperative pain medications used among dentists in
      the United States.Although these medications are highly effective in the postoperative dental
      pain management, not all patients optimally benefit from this therapy. Many suffer adverse
      consequences such as nausea, emesis, and psychomotor impairment, and there is a high
      prevalence of opioid prescription misuse among substance abusers within the dental patient
      population.

      The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of
      postoperative dental pain has demonstrated equivalent or superior analgesic effects compared
      to opioid analgesic therapies, typically with significantly less adverse effects.However,
      despite these results, dentists have encountered a high variability in the success of
      non-opioid analgesic responses among the postoperative dental pain population.Thus, new
      strategies for earlier recognition of analgesic responses for pain medications is fundamental
      in the field of dentistry. Therefore, this study will evaluate the clinical utility of
      pharmacogenomic testing in acute postoperative dental pain management among healthy adults
      who undergo extraction of impacted mandibular third molar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are able to read, comprehend, and sign the consent form, and willing to
             stay in the study unit for up to 12 hours.

          -  Patients who are reliable, cooperative, and of adequate intelligence to record the
             requested information on the questionnaire form(s).

          -  Women of childbearing potential who are not pregnant, as assessed by a urine pregnancy
             quick test on the day of the procedure, prior to surgery. Women must be using a method
             of birth control deemed acceptable by the investigator and continue to use this method
             during the duration of dosing with study medication

          -  Patient who develop sufficient levels of pain (rated at 50mm or more out of a 100 mm)
             on the DPIS within 6 hours post-surgical extraction.

          -  Patients who agree not to take analgesics other than protocol-defined rescue
             analgesics during the post-operative treatment period of 6 hours.

               -  Patients who agree to refrain from alcohol and sedative consumption during the
                  post-operative period of 6 hours.

          -  Patients scheduled to undergo surgical removal of 3 or more impacted third molars, at
             least 1 of which must be a bony mandibular impaction. In addition, the sum of the
             dental impaction scores must be 9 or above, carried out by investigator.

        Exclusion Criteria:

        Subjects with:

          -  Known opioids and NSAIDs allergies (or induced asthmatic attacks)

          -  Known history of opioid abuse

          -  Recent history of gastrointestinal ulceration

          -  History of aspirin intolerance/cross-sensitivity

          -  Recent myocardial disease

          -  Uncontrolled hypertension

          -  Patients receiving anticoagulation therapy

          -  Uncontrolled diabetes

          -  Pregnant women

          -  Immunosuppression

          -  Recent history of opioid or NSAID therapies

          -  Subjects who do not achieve a qualifying baseline pain threshold of 50mm out of 100mm
             on the visual analog DIPS within 6 hours of completion of surgery