Opioid Analgesic Reduction Study (OARS) - Pilot
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: OPIOID; NON-OPIOID
Intervention description: Analgesic assignment; Analgesic assignment
Intervention MeSH terms: Analgesics, Opioid; Analgesics; Analgesics, Non-Narcotic
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioids; Pain Management; Analgesics

Summary:

      The purpose of this study is to test protocols being developed for the conduct of a large
      sale multi-site clinical trial which will compare opioids to non-opioids for managing
      post-surgical impacted 3rd molar extraction pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and non-pregnant women who are at least 18 years of age, who are able to
             refrain from driving or operating heavy machinery while taking the study medication
             will be able to participate.

          -  Subjects who are English speaking and are able to provide consent will be considered.

          -  Subjects must be in generally good health and able to take ibuprofen, paracetamol
             (acetaminophen), and hydrocodone.

        Exclusion Criteria:

        Subjects who self-report the following history will be excluded from participating:

          -  Individual under the age of 18

          -  History of gastrointestinal bleeding and/or peptic ulcer

          -  History of renal disease (excluding kidney stones)

          -  History of hepatic disease

          -  History of bleeding disorder

          -  History of respiratory depression

          -  Any prior respiratory effect of an opioid or other anesthetic drug that required
             respiratory support postoperatively

          -  Active or untreated asthma

          -  History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or
             anesthesia

          -  Currently taking any of the following medications:

               -  CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin),
                  azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g.,
                  ritonavir), which may increase plasma concentrations of hydrocodone bitartrate
                  and acetaminophen and prolong opioid adverse reactions, and which may cause
                  potentially fatal respiratory depression

               -  CNS depressants.

          -  Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism

          -  History of drug or alcohol abuse (excludes marijuana use)

          -  Family history of drug or alcohol abuse in a first degree relative

          -  Has had one or more opioid prescription filled within the past 6 months

          -  Currently pregnant or lactating

        Patients would also be excluded due to any additional criteria that would place the
        individual at increased risk or preclude the individual's full compliance with or
        completion of the study which includes:

          -  Prior participation in this study

          -  Inability or refusal to provide informed consent