Background and Objectives: In this randomized, placebo-controlled, double-blind study, the efficacy and safety of rofecoxib* 50 mg was evaluated in patients undergoing major abdominal gynecologic surgery.
Methods: Patients were randomized to receive rofecoxib 50 mg (n = 81) or placebo (n = 83) ∼2 hours before total abdominal hysterectomy or myomectomy and once daily over the ensuing 4 days. Clinical measurements included average daily opioid use over the 5-day period (primary endpoint), pain intensity on movement, and opioid-related side effects.
Results: Patients receiving rofecoxib required 32% less (P = .001) intravenous and oral opioids to relieve their postoperative pain from days 1 to 5 (primary endpoint), used 21% less (P = .011) on day 1, and 42% less (P < .001) from days 2 to 5. The rofecoxib group experienced less pain upon movement (P < .001), less sedation (P = .007), and a 24% reduction in the rate of antiemetic intake (P = .037) over the first 72 hours postsurgery. Earlier mean times to first flatus (−10.1 hours, P = .001), first bowel movement (−14.1 hours, P = .037), and time to hospital discharge (−10.9 hours; 95% confidence interval, −17.1 to −4.7) occurred in the rofecoxib group. There were no significant intergroup differences in blood loss, wound healing, or overall adverse experiences.
Conclusions: Compared with placebo, perioperative administration of rofecoxib 50 mg provided significant opioid sparing, significantly better pain control, improved clinical outcomes, and was well tolerated.
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Supported by Merck Research Laboratories.
R. Sinatra has served as a member of the Analgesic Advisory Board for Merck & Co., Inc.M.M. Kashuba, J.A. Boice, T. Loeys, A. Ko, P.F. Cavanaugh, and A.S. Reicin are employees of Merck & Co., Inc., and own stock and/or hold stock options in the company.