A clinical trial demonstrates the analgesic activity of intravenous parecoxib sodium compared with ketorolac or morphine after gynecologic surgery with laparotomy

Objective: The purpose of this study was to compare the analgesic activity of 2 doses of parecoxib sodium, ketorolac, and morphine with placebo after gynecologic surgery that requires laparotomy. Study design: In a randomized, controlled, double-blind, parallel-group study, 208 patients, after surgical hysterectomy, received single-dose intravenous placebo, parecoxib sodium 20 mg or 40 mg,. ketorolac 30 mg, or morphine 4 mg followed by multiple-dose parecoxib sodium or ketorolac as needed. Primary efficacy variables were time to onset of analgesia, pain intensity differences, pain relief, time to first rescue/remedication, and global evaluation of study medication. Results: Single-dose parecoxib sodium 40 mg provided significantly better pain responses to placebo or morphine 4 mg and was comparable to ketorolac 30 mg. Multiple-dose parecoxib sodium 20 mg, 4 times daily, or 40 mg, twice daily, was comparable to ketorolac 30 mg, 4 times daily. Parecoxib sodium was well tolerated. Conclusion: Parecoxib sodium is an effective analgesic in the management of acute postoperative pain after laparotomy surgery. (C) 2004 Elsevier Inc. All rights reserved.