Efficacy and safety of intravenous parecoxib sodium in relieving acute postoperative pain following gynecologic laparotomy surgery.
BACKGROUND
This study tested the hypothesis that an injectable cyclooxygenase (COX)-2-specific inhibitor will be at least as effective and well tolerated as a COX-nonspecific conventional nonsteroidal antiinflammatory drug (NSAID) by comparing the analgesic efficacy and tolerability of one intravenous dose of parecoxib sodium, an injectable prodrug of the novel COX-2-specific inhibitor, valdecoxib, with ketorolac and placebo in postoperative laparotomy surgery patients. Intravenous morphine, 4 mg, was studied as a positive analgesic control.


METHODS
In this multicenter, double-blinded, placebo-controlled study, women experiencing moderate-to-severe pain on the first day after abdominal hysterectomy or myomectomy received one intravenous dose of parecoxib sodium, 20 or 40 mg, ketorolac, 30 mg, morphine, 4 mg, or placebo. Analgesic efficacy and tolerability were evaluated for 24 h postdose or until patients, whose pain was not adequately controlled, opted to receive rescue analgesia.


RESULTS
Two hundred two patients were enrolled. All treatment groups had comparable demographics and baseline pain status. All active treatments had an equally rapid time to onset of analgesia (10-23 min). Overall, each parecoxib sodium dose and ketorolac were significantly superior to morphine and placebo for most measures of analgesic efficacy at most time points, including a significantly longer (two- to threefold) time to rescue analgesia (P </= 0.05). All treatments were well tolerated.


CONCLUSIONS
Single intravenous doses of parecoxib sodium, 20 mg and 40 mg, have comparable analgesic effects and are well tolerated after laparotomy surgery. Parecoxib sodium appears to be as effective as intravenous ketorolac, 30 mg, and superior to intravenous morphine, 4 mg.
Barton
Scott F
SF
Columbia St. Mark's Hospital, Salt Lake City, Utah, USA.
Langeland
Fred F
FF
Snabes
Michael C
MC
LeComte
Diane
D
Kuss
Michael E
ME
Dhadda
Shobha S
SS
Hubbard
Richard C
RC
D000328:Adult; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007275:Injections, Intravenous; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D020910:Ketorolac / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009020:Morphine / Q000627:therapeutic use; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*
D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; D009020:Morphine; C409945:parecoxib; D020910:Ketorolac