STUDY OBJECTIVE: To assess the analgesic efficacy of a multidose, multiday regimen of intravenous (IV) parecoxib sodium (parecoxib). DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. SETTING: Postoperative recovery area and inpatient care facility. PATIENTS: 422 patients who had undergone gynecologic surgery via laparotomy participated (day 1), and 414 patients were randomized (day 2). INTERVENTIONS: After surgery on day 1, all patients received parecoxib 40 mg (IV), followed by 20 mg (IV) one to 12 hours later; patients were then randomized to receive parecoxib 20 mg (IV) twice daily (n = 211) or placebo (IV) twice daily (n = 203) on days 2 to 5. Patients were permitted rescue medication as needed. MEASUREMENTS: Primary efficacy measures were summed pain intensity through 24 hours (SPI-24) and Patient's Global Evaluation of Study Medication on days 2 and 3. MAIN RESULTS: In the parecoxib treatment group, 24-hour summed pain intensity scores were significantly lower than in the placebo treatment group (P < 0.001) on days 2 and 3. More patients in the parecoxib treatment group rated their treatment as "excellent" or "good" using the Patient's Global Evaluation of Study Medication (P < 0.001) on days 2 and 3. Patients treated with parecoxib had lower pain intensity and consumed less rescue medication compared with the placebo-treated patients. CONCLUSION:Multidose parecoxib was well tolerated over several days and provided improved pain control after gynecologic surgery.
RCT Entities:
STUDY OBJECTIVE: To assess the analgesic efficacy of a multidose, multiday regimen of intravenous (IV) parecoxib sodium (parecoxib). DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. SETTING: Postoperative recovery area and inpatient care facility. PATIENTS: 422 patients who had undergone gynecologic surgery via laparotomy participated (day 1), and 414 patients were randomized (day 2). INTERVENTIONS: After surgery on day 1, all patients received parecoxib 40 mg (IV), followed by 20 mg (IV) one to 12 hours later; patients were then randomized to receive parecoxib 20 mg (IV) twice daily (n = 211) or placebo (IV) twice daily (n = 203) on days 2 to 5. Patients were permitted rescue medication as needed. MEASUREMENTS: Primary efficacy measures were summed pain intensity through 24 hours (SPI-24) and Patient's Global Evaluation of Study Medication on days 2 and 3. MAIN RESULTS: In the parecoxib treatment group, 24-hour summed pain intensity scores were significantly lower than in the placebo treatment group (P < 0.001) on days 2 and 3. More patients in the parecoxib treatment group rated their treatment as "excellent" or "good" using the Patient's Global Evaluation of Study Medication (P < 0.001) on days 2 and 3. Patients treated with parecoxib had lower pain intensity and consumed less rescue medication compared with the placebo-treated patients. CONCLUSION: Multidose parecoxib was well tolerated over several days and provided improved pain control after gynecologic surgery.