A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia.
We assessed the efficacy and safety of ondansetron (0.1 mg/kg IV) prophylactically administered before surgery for prevention of postoperative vomiting (POV) in a double-blind, placebo-controlled study of 670 pediatric patients, 1- to 24-mo-old, undergoing elective surgery under general anesthesia. The study enrolled 335 children in each treatment group (ondansetron versus placebo). Significantly fewer children treated with ondansetron exhibited emesis or discontinued the study prematurely after surgery (ondansetron, 11%; placebo, 28%; odds ratio = 0.33; P < 0.0001). The number required to treat prophylactically with ondansetron to prevent POV was approximately six. Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21). The incidence of POV and other antiemetic effects of ondansetron were similar in children aged 1-12 mo and 13-24 mo and in children prospectively expected or not expected to require opioids as part of their anesthetic or analgesic management. Ondansetron was well tolerated; the incidence of adverse events considered possibly related to study drug was similar between treatment groups (ondansetron, 1.8%; placebo, 1.5%).


CONCLUSIONS
This prospective, randomized, double-blind, placebo-controlled study establishes the efficacy and tolerability of IV ondansetron (0.1 mg/kg) in the prevention of postoperative emesis in 1- to 24-mo-old pediatric patients undergoing elective surgery under general anesthesia.
Khalil
Samia N
SN
*Department of Anesthesiology, University of Texas Health Science Center, Houston; †Department of Pediatric Anesthesiology, Children's Memorial Hospital, the Feinberg School of Medicine at Northwestern University, Chicago, Illinois; ‡Department of Anesthesiology, Children's National Medical Center, Washington, DC; §Department of Anesthesia, British Columbia's Children's Hospital, Vancouver; ∥Department of Anesthesiology, Children's Hospital of Pittsburgh; and ¶GlaxoSmithKline, Upper Providence, Pennsylvania.
Roth
Andrew G
AG
Cohen
Ira T
IT
Simhi
Eli
E
Ansermino
J Mark
JM
Bolos
Mariana E
ME
Coté
Charles J
CJ
Hannallah
Raafat S
RS
Davis
Peter J
PJ
Brooks
Peter B
PB
Russo
Mark W
MW
Anschuetz
Gaya C
GC
Blackburn
Linda M
LM
D000768:Anesthesia, General; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D016017:Odds Ratio; D017294:Ondansetron / Q000008:administration & dosage / Q000627:therapeutic use*; D020250:Postoperative Nausea and Vomiting / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
D000932:Antiemetics; D017294:Ondansetron