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Patient-Oriented Evidence That Matters

Ondansetron Effective for Gastroenteritis with Vomiting

MARK EBELL, M.D., M.S.

 Am Fam Physician. 2006;74(5):830-831

Clinical Question: Is ondansetron (Zofran) safe and effective for dehydrated children with gastroenteritis?

Setting: Emergency department

Study Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: Although oral rehydration is the treatment of choice for children with gastroenteritis, it can be a
challenge when the child cannot keep anything down. This leads to overuse of intravenous hydration,
particularly given the time pressures in the emergency department. The authors considered for inclusion in
the study any mildly to moderately dehydrated child who had had at least one episode of diarrhea and one
episode of vomiting in the previous four hours. Those with a body weight of less than 17 lb 10 oz (8 kg), who
were severely dehydrated using standardized symptoms (e.g., clammy or cool skin, very dry mucosa, no tears,
moderate tachycardia, no urine for at least six hours, limp, lethargic), and those with signi�cant comorbidities
were excluded.

Of the 243 children asked to enroll, 215 underwent randomization (allocation concealed) to ondansetron or
placebo. The dose of ondansetron was 2 mg for children who weighed between 17 lb 10 oz and 33 lb (15 kg),
4 mg for those who weighed 33 lb to 66 lb (30 kg), and 8 mg for those who weighed more than 66 lb. The dose
was repeated if children vomited within 15 minutes of taking the medicine. The mean age of the children was
28 months, 57 percent were boys, and they had a mean of nine episodes of vomiting and six episodes of
diarrhea in the previous 24 hours. Groups were similar at baseline, and analysis was by intention to treat.

Children receiving ondansetron were less likely to vomit while being given liquids (14 versus 35 percent; P =
.001; number needed to treat [NNT] = 5), had fewer vomiting episodes (0.18 versus 0.65; P < .001), and were
less likely to require intravenous rehydration (14 versus 31 percent; P = .003; NNT = 5). There was no
difference in the number of children requiring hospitalization or the percentage returning to the emergency
department. The drug was well tolerated, although there was a mean of 0.9 additional episodes of diarrhea for
children who received ondansetron.
Bottom Line: Ondansetron, when given to children who are mildly to moderately dehydrated because of
diarrhea and vomiting, improves their ability to comply with oral rehydration and reduces the need for
intravenous hydration. (Level of Evidence: 1b)

Author Information
MARK EBELL, M.D., M.S.

Reference(s)
1. Freedman SB, et al. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med.
April 20, 2006;354:1698-705.

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Copyright © 2006 by the American Academy of Family Physicians.

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