Oral Versus Intravenous Rehydration of Moderately Dehydrated Children: A Randomized, Controlled Trial

ABSTRACT. Background. Dehydration from viral gastroenteritis is a significant pediatric health problem. Oral rehydration therapy (ORT) is recommended as first-line therapy for both mildly and moderately dehydrated children; however, three quarters of pediatric emergency medicine physicians who are very familiar with the American Academy of Pediatrics recommendations for ORT still use intravenous fluid therapy (IVF) for moder-ately dehydrated children. Objective. To test the hypothesis that the failure rate of ORT would not be>5 % greater than the failure rate of IVF. Secondary hypotheses were that patients in the ORT group will (1) require less time initiating therapy, (2) show more improvement after 2 hours of therapy, (3) have fewer hospitalizations, and (4) prefer ORT for fu-ture episodes of dehydration. Methods. A randomized, controlled clinical trial (noninferiority study design) was performed in the emer-gency department of an urban children’s hospital from December 2001 to April 2003. Children 8 weeks to 3 years old were eligible if they were moderately dehydrated, based on a validated 10-point score, from viral gastroen-teritis. Patients were randomized to receive either ORT or IVF during the 4-hour study. Treating physicians were masked and assessed all patients before randomization at 2 and 4 hours of therapy. Successful rehydration at 4 hours was defined as resolution of moderate dehydra-tion, production of urine, weight gain, and the absence severe emesis (>5 mL/kg). Results. Seventy-three patients were enrolled in the study: 36 were randomized to ORT and 37 were random-ized to IVF. Baseline dehydration scores and the number of prior episodes of emesis and diarrhea were similar in the 2 groups. ORT demonstrated noninferiority for the main outcome measure and was found to be favorable with secondary outcomes. Half of both the ORT and IVF groups were rehydrated successfully at 4 hours (differ-ence: 1.2%; 95 % confidence interval [CI]: 24.0 % to 21.6%). The time required to initiate therapy was less in the ORT group at 19.9 minutes from randomization, com-pared with 41.2 minutes for the IVF group (difference