OxyNorm Capsules in Post-Operative Pain Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: OxyNorm Capsules; Morphine tablet
Intervention description: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours; dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized
      patients with moderate to severe pain following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either sex aged 18 to 80 years inclusive.

          2. Patients who have given written informed consent to participate in the study.

          3. Able and willing to communicate with the investigator and his/her staff.

          4. Free of anesthesia as assessed through question and answer interaction with nurse at
             which time oral medication is indicated.

          5. Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting
             analgesics for pain relief.

        Exclusion Criteria:

          1. Patients have developed tolerance to or dependence on narcotic analgesics and/or
             alcohol.

          2. Patients with ASA ≥ 3 .

          3. Have any concomitant medical condition that would be adversely affected by analgesics
             or confound the quantification of analgesia, or could affect the absorption,
             metabolism or excretion of the study drugs in any clinically significant fashion.

          4. Have known hypersensitivity to any of the study medications or related agents.

          5. Have taken analgesic medications within three hours (wash-out) prior to dosing.

          6. Have developed complications from the surgical procedure that would confound the
             study.

          7. Have a history of severe iatrogenic adverse experiences.

          8. Mothers nursing their infant during the 24 hours following study drug administration,
             or pregnant women.

          9. Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.

         10. Surgery in patients with epidural anesthesia

         11. Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times
             upper limit) and abnormal renal function.

         12. Patients with medical history of recovering from abnormal surgery anesthesia.

         13. Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg,
             Diastolic blood pressure 110Hg).

         14. Patients with shock.

         15. Patients with COPD.

         16. According to investigator to determine, patients are in addition the inclusion
             criteria and exclusion criteria for any other reason than not suitable in this study.