Pediatrics/original researchEffect of Ondansetron on the Incidence of Vomiting Associated With Ketamine Sedation in Children: A Double-Blind, Randomized, Placebo-Controlled Trial
Introduction
Ketamine is widely used for emergency department (ED) procedural sedation and analgesia in children.1, 2 Important adverse events associated with ketamine include hypoxia, laryngospasm, apnea, vomiting, and emergency reactions.2, 3, 4 The reported frequency of vomiting ranges from 3.8% to 18.7%.1, 2, 5, 6, 7, 8, 9, 10, 11 Ondansetron has been widely used in a variety of settings to reduce vomiting associated with viral illnesses, chemotherapy, and anesthesia.12, 13, 14, 15, 16 This antiemetic is increasingly used in the ED, including for the treatment of ketamine-associated vomiting.
Although ondansetron is often used to treat ketamine-associated vomiting, its efficacy for prophylaxis is unknown. Vomiting may increase ED length of stay and decrease patient satisfaction. Although clinically apparent pulmonary aspiration has never been reported during ED procedural sedation and analgesia in children, vomiting during such sedation could increase its risk.17, 18
We wished to determine whether vomiting associated with intravenous (IV) ketamine may be reduced or eliminated by the addition of prophylactic ondansetron.
Section snippets
Study Design
A convenience sample of children was enrolled in a randomized, double-blind, placebo-controlled trial of ondansetron with ED ketamine sedation. Written, informed consent was obtained from all parents or guardians, as well as assent from all children 7 years of age or older, before enrollment into the study. The study was approved by the Colorado Multiple Institutional Review Board.
Setting
This study was conducted at a university-affiliated, urban children's hospital ED, which is a regional pediatric
Results
This study was conducted from January 2003 to August 2005. Eligible and enrolled patients during the study period are shown on the patient flow diagram (Figure). Two hundred sixty-eight patients were randomized; 850 patients met criteria but were not enrolled because of parent or patient refusal or, more commonly, nonavailability of a research assistant to enroll patients during busy ED patient volume times. Characteristics of the enrolled patients are listed (Table 1).
Patients who received
Limitations
This study has several important limitations. Because of our inability to enroll consecutive patients in a busy ED, this work represents a convenience sample of patients. Failure to enroll all eligible patients makes this study susceptible to selection bias. As a result of our sample size, the 95% CI for the number needed to treat is relatively wide, suggesting the true effect may be larger or smaller. In addition, although telephone follow-up was obtained for almost 83% of patients, those not
Discussion
Previous studies of IV ketamine in the ED have reported a wide range of vomiting (3.8% to 18.7%), with research from our institution reporting 9.3% t 18.7%.2, 11, 26 In addition, some children (3.6% o 9.1%) who do not vomit in the ED do vomit after discharge.2, 11 Because of these relatively high rates of vomiting, we sought to determine whether the addition of the antiemetic drug ondansetron could decrease or prevent vomiting associated with ketamine.
Several factors may influence vomiting
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Supervising editor: Steven M. Green, MD
Author contributions: WTL, JEW, and MGR conceived of the study and designed the trial. WTL and JEW supervised data collection. LB provided statistical analyses of the data. MR drafted the article, and all authors contributed to its revision. JEW takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that may create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. Financial support was from the Children's Hospital Research Institute, Denver, CO.
Publication dates: Available online March 19, 2008.
Reprints not available from the authors.