Rofecoxib administration to paediatric patients undergoing adenotonsillectomy.
BACKGROUND
Rofecoxib is a selective COX-2 inhibitor that does not interfere with platelet function and is associated with fewer bleeding complications than other nonsteroidal anti-inflammatory agents (NSAIDs). Our aims were to evaluate the safety and the efficacy of rofecoxib administration to paediatric patients undergoing adenotonsillectomy (T&A).


METHODS
We conducted a double-blind, randomized, placebo-controlled study of rofecoxib in 45 ASA 1-2 patients > or = 4 years of age undergoing outpatient T&A. All patients received midazolam 0.5 mg x kg(-1) (max 15 mg) p.o. and either rofecoxib 1 mg x .kg(-1) (max 25 mg) or placebo p.o. 30 min preoperatively. All patients had a standardized anaesthetic and were extubated awake in the operating room at the conclusion of surgery. The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores were obtained on arrival in the postanaesthetic care unit (PACU). Morphine 25 microg x kg(-1) i.v. were administered up to six times for pain in the PACU. Wong-Baker FACES Scales were obtained at discharge from the PACU and the day surgery unit (DSU). Outcome measures included intraoperative estimated blood loss (EBL), pain scores, PACU morphine requirements and discharge times.


RESULTS
There were 23 patients in the rofecoxib group and 22 patients in the placebo group. There were no differences between the rofecoxib and placebo groups in terms of bleeding, pain scores, PACU morphine requirements, PACU times or DSU times.


CONCLUSIONS
Rofecoxib administration to paediatric patients undergoing T&A did not result in increased bleeding. Rofecoxib, however, was not found to decrease morphine use or improve pain scores prior to hospital discharge in T&A patients who received intraoperative morphine and acetaminophen.
Sheeran
P W
PW
Departments of Anesthesiology and Pediatrics, University of Texas Southwestern Medical Center, USA. psheer@childmedodallas.fx.us
Rose
J B
JB
Fazi
L M
LM
Chiavacci
R
R
McCormick
L
L
D000233:Adenoidectomy / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006776:Hospitals, Pediatric; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010149:Postoperative Pain / Q000517:prevention & control*; D011229:Preanesthetic Medication; D013450:Sulfones; D014068:Tonsillectomy / Q000009:adverse effects*
D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib