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Am. J. Obstet. Gynecol. · Oct 2004
Randomized Controlled Trial Comparative Study Clinical TrialA clinical trial demonstrates the analgesic activity of intravenous parecoxib sodium compared with ketorolac or morphine after gynecologic surgery with laparotomy.
- George B Bikhazi, Michael C Snabes, Zahid H Bajwa, Derek J Davis, Diane LeComte, Louise Traylor, and Richard C Hubbard.
- University of Miami School of Medicine, Miami, FL, USA.
- Am. J. Obstet. Gynecol. 2004 Oct 1;191(4):1183-91.
ObjectiveThe 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 DesignIn 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.ResultsSingle-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.ConclusionParecoxib sodium is an effective analgesic in the management of acute postoperative pain after laparotomy surgery.
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