Evaluation of the effect of perioperative rofecoxib treatment on pain control and clinical outcomes in patients recovering from gynecologic abdominal surgery : A randomized, double-blind, placebo-controlled clinical study

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 P 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.