Oral ondansetron decreases the need for intravenous fluids in children with gastroenteritis

Article Outline

• Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med 2006;354:1698-705
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Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med 2006;354:1698-705 

Question Among children with gastroenteritis, does a single oral dose of ondansetron control vomiting with minimal side effects?

Design Randomized, controlled trial.

Setting University-based, urban emergency department.

Participants 215 children 6 months through 10 years of age who were treated in a pediatric emergency department for gastroenteritis and dehydration.

Intervention Children were assigned to orally disintegrating ondansetron tablets (2 mg for children 8-15 kg, 4 mg for children 15-30 kg, and 8 mg for children over 30 kg) or placebo. All children received oral rehydration therapy according to a standardized protocol.

Outcomes The primary outcome was the proportion who vomited while receiving oral rehydration. The secondary outcomes were the number of episodes of vomiting and the proportions who were treated with intravenous rehydration or hospitalized.

Main Results As compared with children who received placebo, children who received ondansetron were less likely to vomit (14% vs 35%, Number Needed to Treat [NNT] = 5), vomited less often (mean number of episodes per child, 0.18 vs 0.65; P < .001), had greater oral intake (239 mL vs 196 mL, P = .001), and were less likely to be treated by intravenous rehydration (14% vs 31%, NNT = 6). Although the mean length of stay in the emergency department was reduced by 12% in the ondansetron group, the rates of hospitalization and of return visits to the emergency department did not differ significantly between groups.

Conclusions In children with gastroenteritis and dehydration, a single dose of oral ondansetron reduces vomiting and facilitates oral rehydration and may thus be well-suited for use in the emergency department.

Commentary This article addresses one of the most common illnesses seen by pediatric providers in the office or in the emergency department (ED). This is an interesting study that attempted to treat the vomiting associated with gastroenteritis by using a common pediatric antiemitic, oral ondansetron, to try to decrease the need for intravenous hydration or hospitalization. The study was well-designed, appropriately randomized, and effectively controlled. A representative group of patients with gastroenteritis and dehydration were enrolled and randomized in the study and were followed through the trial. Ondansetron effectively reduced the likelihood of emesis (NNT = 5), the likelihood of intravenous rehydration (NNT = 6), and shortened the length of stay in the ED. The main side effect was diarrhea, which was more common in the ondansetron group, but not statistically significant. However, there was no significant difference in the number of children admitted to the hospital for rehydration or for return visits to the emergency department. The decrease in the length of ED stay may not be clinically meaningful (106 vs 120 minutes). It should be noted that the admission rates were low, and the study may not have had enough power to detect a meaningful difference with the small number of patients admitted. That being said, the charges for intravenous rehydration are significant at our institution (∼$900), compared with the cost of ondansetron ($28 for a 4-mg dose). These methods could easily be duplicated in providers’ offices and represent an adjunct to current oral rehydration efforts. Using the NNT of 6, it would cost $168 to treat the 5 extra patients needed to prevent one additional intravenous rehydration. This is potentially meaningful savings, and, because there were no significant side effects noted, it could be considered in other outpatient settings where children can be monitored while receiving oral rehydration.