Conditions: Pain, Postoperative
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 776
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.

Detailed description:

Arms:
arm 1: Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days. arm 2: Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days. arm 3: Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days. arm 4: Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.

Interventions: intervention 1: Etoricoxib 90 mg intervention 2: Etoricoxib 120 mg intervention 3: Ibuprofen 600 mg intervention 4: Matching Placebo for Etoricoxib 120 mg intervention 5: Matching Placebo for Etoricoxib 90 mg intervention 6: Matching Placebo for Ibuprofen intervention 7: Morphine intervention 8: Oxycodone
Intervention descriptions: intervention 1: One 90 mg tablet once daily intervention 2: Two 60 mg tablets once daily intervention 3: One tablet three times daily intervention 4: Two tablets once daily intervention 5: One tablet once daily intervention 6: One tablet three times daily intervention 7: As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection intervention 8: 5 mg as needed

Protocol document: