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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
  1. Raymond S. Sinatra, M.D., Ph.D.,
  2. Judith A. Boice, Ph.D.,
  3. Tom L. Loeys, Ph.D.,
  4. Amy T. Ko, M.P.H.,
  5. Maureen M. Kashuba, B.S.,
  6. Jonathan S. Jahr, M.D.,
  7. Steven Rhondeau, M.D.,
  8. Neil Singla, M.D.,
  9. Paul F. Cavanaugh Jr, Ph.D. and
  10. Alise S. Reicin, M.D.
  1. Department of Anesthesiology, Yale University School of Medicine, New Haven, CT Merck Research Laboratories, Rahway, NJ Merck Research Laboratories, Brussels, Belgium Departments of Anesthesiology, Charles R. Drew University of Medicine and Science, Martin Luther King, Jr./Charles R. Drew Medical Center, and the David Geffen School of Medicine at UCLA, Los Angeles, CA LDS Hospital, Salt Lake City, UT Clinical Management Services, Huntington Memorial Hospital, Pasadena, CA.
  1. Reprint requests: Raymond S. Sinatra, M.D., Ph.D., Department of Anesthesiology, Yale University School of Medicine, TMP-3, 333 Cedar Street, New Haven, CT 06520-8051. E-mail: raymond.sinatra{at}


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.

  • Rofecoxib
  • Perioperative
  • Analgesia
  • Hysterectomy
  • Pain

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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.