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.

Abstract

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) approximately 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.

• Authors: Raymond S Sinatra, Judith A Boice, Tom L Loeys, Amy T Ko, Maureen M Kashuba, Jonathan S Jahr, Steven Rhondeau, Neil Singla, Paul F Cavanaugh Jr, Alise S Reicin, Protocol 159 Study Group
• Journal: Regional anesthesia and pain medicine (Reg Anesth Pain Med) 2006 Mar-Apr Vol. 31 Issue 2 Pg. 134-42 ISSN: 1098-7339 [Print] England
• PMID: 16543099 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lactones
• Sulfones
• rofecoxib

Topics

• Adult
• Aged
• Double-Blind Method
• Female
• Gynecologic Surgical Procedures
• Humans
• Hysterectomy
• Lactones (administration & dosage)
• Middle Aged
• Pain Measurement (drug effects)
• Pain, Postoperative (drug therapy, epidemiology)
• Preoperative Care (methods)
• Sulfones (administration & dosage)