Parecoxib sodium administered over several days reduces pain after gynecologic surgery via laparotomy.
OBJECTIVE
To assess the analgesic efficacy of a multidose, multiday regimen of intravenous (IV) parecoxib sodium (parecoxib).


METHODS
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.


METHODS
Postoperative recovery area and inpatient care facility.


METHODS
422 patients who had undergone gynecologic surgery via laparotomy participated (day 1), and 414 patients were randomized (day 2).


METHODS
After surgery on day 1, all patients received parecoxib 40 mg (IV), followed by 20 mg (IV) one to 12 hours later; patients were then randomized to receive parecoxib 20 mg (IV) twice daily (n = 211) or placebo (IV) twice daily (n = 203) on days 2 to 5. Patients were permitted rescue medication as needed.


METHODS
Primary efficacy measures were summed pain intensity through 24 hours (SPI-24) and Patient's Global Evaluation of Study Medication on days 2 and 3.


RESULTS
In the parecoxib treatment group, 24-hour summed pain intensity scores were significantly lower than in the placebo treatment group (P < 0.001) on days 2 and 3. More patients in the parecoxib treatment group rated their treatment as "excellent" or "good" using the Patient's Global Evaluation of Study Medication (P < 0.001) on days 2 and 3. Patients treated with parecoxib had lower pain intensity and consumed less rescue medication compared with the placebo-treated patients.


CONCLUSIONS
Multidose parecoxib was well tolerated over several days and provided improved pain control after gynecologic surgery.
Snabes
Michael C
MC
Pfizer Global Research and Development, Skokie, IL, USA. mcsnabes@comcast.net
Jakimiuk
Artur J
AJ
Kotarski
Jan
J
Katz
Teresa K
TK
Brown
Mark T
MT
Verburg
Kenneth M
KM
D000328:Adult; D000368:Aged; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D007813:Laparotomy; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*
D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; C409945:parecoxib