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

Abstract

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. 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. 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. Parecoxib sodium is an effective analgesic in the management of acute postoperative pain after laparotomy surgery.