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TORONTO, April 20 - A single oral dose of the antiemetic Zofran (ondansetron) can reduce vomiting by more than half and facilitate oral rehydration in children with gastroenteritis, according to pediatric emergency researchers.

In a prospective double-blind study of 214 children ages six months through 10 years treated in two pediatric emergency departments, investigators at the University of Toronto here and Northwestern University in Chicago found that such an approach could increase the use of oral-rehydration therapy, compared with intravenous rehydration, for mild-to-moderate dehydration when vomiting is a major symptom.

Use of the antiemetic also wound up getting the children discharged from the ER more quickly than those in a placebo group, reported Stephen Freedman, M.D., of the University of Toronto, and colleagues at Northwestern, in the April 20 issue of the New England Journal of Medicine.

In the study, 107 children with gastroenteritis and dehydration were randomized to treatment with a single 4 mg orally disintegrating Zofran tablet and 107 to placebo.

Compared with the placebo children, those given Zofran were less likely to vomit (14% versus. 35%) (relative risk, 0.40; 95% CI, 0.26 to 0.61), and vomited less often (mean number of episodes per child 0.18 vs. 0.65; P<0.001)

The Zofran children also managed a greater oral intake (239 mL versus. 196 mL, P=0.001) and were half as likely to be treated with intravenous rehydration (14% vs. 31%; RR, 0.46; 95% CI 0.26-0.79).

Although the mean length of stay in the emergency department was reduced by 12% for the Zofran children (1.77 versus two hours; P=0.02), the rates of hospitalization (4% and 5% respectively) and of return visits to the ED (19% and 22%) did not differ significantly, the researchers reported.

No cardiovascular or respiratory events occurred. Urticaria developed in one child given placebo. However, children given Zofran had more episodes of diarrhea while undergoing oral rehydration than those who got a placebo (1.4 versus 0.5, P<0.001), even after adjustment for the number of episodes before arrival, the researchers said.

The oral-rehydration period in the emergency department was limited to one hour to mimic routine clinical practice. It might have been more successful for some of the children in whom it failed if they had been observed for four hours, as recommended by the WHO, Dr. Freedman said.

In a cost analysis for the Zofran study, the researchers calculated that based on $35.75 per 4 mg tablet at their hospital, the total cost of the drugs used in the trial would have been $3,825. The reduction in cost resulting from avoiding insertion of IV catheters ($124.74 per child) and hospitalization ($1,900 per admission) was a somewhat higher $4,145. Thus, Dr. Freedman said, the use of Zofran may reduce overall costs while providing individual benefits.

The tablet is easy to administer, has few side effects, and is safe and effective, the researchers said. "Therefore it may be useful therapy in an emergency department for children with vomiting and mild-to-moderate dehydration as a result of gastroenteritis," they concluded.

This study was supported by grants from the National Institutes of Health and GlaxoSmithKline, Zofran's maker.

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