A Double-Blind Multicenter Study of the Safety and Efficacy of Parecoxib Sodium/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain in Patients Who Have Coronary Bypass Graft Via Median Sternotomy

简要总结

主要结局

次要结局

• Combined incidence of the number of patients with at least 1 reported CRAE and the combined incidence of the number of patients with specific reported CRAEs summarized according to the categories listed above(Day 30)
• Rate of supplemental analgesia consumed(Days 1-10)
• Vital signs(Day 30)
• Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)(Day 1)
• Opioid-related Symptoms Distress Scale (OR-SDS)(Days 1-10)
• Time to last Patient Controlled Analgesia (PCA) dose
• Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)
• Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs(Day 30)
• Adverse events(Day 30)
• Serious adverse events(Day 30)
• Clinical laboratory assessments(Day 30)
• Peak Pain Intensity (PPI) of sternotomy alone and overall body pain(Days 1-10)
• Patient's and Physician's Global Evaluation of Study Medication(At time of transition from intravenous to oral medication and final visit/early termination)
• Modified Brief Pain Inventory-short form (mBPI-sf)(Days 1-10)
• SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)(Days 1-10)