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PEDIATRIC ANESTHESIA

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

Samia N. Khalil, MD^*, Andrew G. Roth, MD, Ira T. Cohen, MD, Eli Simhi, MD^||, J. Mark Ansermino, MBChB, Mariana E. Bolos, MD^*, Charles J. Coté, MD, Raafat S. Hannallah, MD, Peter J. Davis, MD^||, Peter B. Brooks, MBChB, Mark W. Russo, MD, PhD^¶, Gaya C. Anschuetz, MS^¶, and Linda M. Blackburn, RN, MS^¶

*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

Address correspondence and reprint requests to Samia N. Khalil, MD, University of Texas Health Science Center, Department of Anesthesiology, Memorial Hermann Hospital, 6431 Fannin St., Suite 5.020 Houston, TX 77030. Address e-mail to Samia.N.Khalil{at}uth.tmc.edu.

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%).

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