A single oral dose of the antiemetic ondansetron significantly reduced vomiting and mild to moderate dehydration in children treated in a pediatric emergency department for gastroenteritis, allowing more children to be rehydrated orally rather than intravenously, Dr. Stephen B. Freedman reported.
A prospective, double-blind study randomized 215 children aged 6 months through 10 years to receive a disintegrating tablet of oral ondansetron (Zofran) or placebo administered by a nurse while the physicians and research assistants were out of the room. Five seconds after placing the tablet on the patient's tongue, the nurse asked or helped the child to swallow. Children who vomited within 15 minutes received a second dose. Fifteen minutes later, clinicians started a 1-hour period of intense oral rehydration, and oral rehydration could be continued until the patient was sent home or admitted. After the first hour of oral rehydration, the treating physician could choose to give intravenous fluids.
The investigators primarily assessed how many children vomited during oral rehydration therapy by conducting phone interviews with the families 3–7 days later and reviewing patients' records.
Among 107 children in the ondansetron group, 14% vomited while receiving oral rehydration therapy, compared with 35% of 107 children in the placebo group. One child in the ondansetron group was not included in the analysis because parental consent had not been obtained before randomization, said Dr. Freedman, of the University of Toronto, and his associates (N. Engl. J. Med. 2006;354:1698–705). Ondansetron also significantly reduced the mean number of episodes of vomiting, compared with placebo (0.18 vs. 0.65 episodes, respectively). Significantly fewer children in the ondansetron group received intravenous rehydration—14%, versus 31% in the placebo group.
Among the children who did not vomit during oral rehydration in either group, intravenous fluids were started in 5% given ondansetron and 17% given placebo, a significant difference.
Contrary to a study that looked at multiple doses, the single dose of ondansetron did not cause any significant adverse events, and the groups did not differ in the rate of return visits to the emergency department (19% with ondansetron and 22% with placebo). The ondansetron group did have more episodes of diarrhea during the oral rehydration than the placebo group—1.4 vs. 0.5 episodes—but this difference was not significant.
GlaxoSmithKline, which makes ondansetron, provided the tablets but had no other role in the study, and the investigators did not report any other potential conflicts of interest.
The ondansetron dosing was 2 mg for children weighing 8–15 kg, 4 mg for those weighing 16–30 kg, and 8 mg for heavier children.
At a cost of $35.75 per 4-mg tablet, the ondansetron in the study cost a total of $3,825 but saved the hospital $4,145 by avoiding insertion of intravenous catheters (at a cost of $124.74/child) and hospitalizations ($1,900/admission).
ELSEVIER GLOBAL MEDICAL NEWS