Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial
Article Outline
Spandorfer PR, Alessandrini EA, Joffe MD, Localio R, Shaw KN. Pediatrics 2005;115:295-301.
Context Dehydration from viral gastroenteritis is a significant pediatric health problem. Oral rehydration therapy (ORT) is recommended as firstline 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 moderately dehydrated children.
Objectives 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 future episodes of dehydration.
Design Randomized, controlled clinical trial (noninferiority study design).
Setting Emergency department of an urban children's hospital from December 2001 to April 2003.
Participants Children 8 weeks to 3 years old who were moderately dehydrated, based on a validated 10-point score, from viral gastroenteritis.
Interventions Patients were randomized to receive either ORT or IVF during the 4-hour study.
Main Outcome Measures Successful rehydration at 4 hours was defined as resolution of moderate dehydration, production of urine, weight gain, and the absence of severe emesis (>5 mL/kg).
Results 73 patients were enrolled in the study: 36 were randomized to ORT and 37 were randomized 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 (difference: −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, compared with 41.2 minutes for the IVF group (difference: −21.2 minutes; 95% CI: −10.3 to −32.1 minutes). There was no difference in the improvement of the dehydration score at 2 hours between the 2 groups (78.8% ORT vs 80% IVF; difference: −1.2%; 95% CI: −20.5% to 18%). Less than one-third of the ORT group required hospitalization, whereas almost half of the IVF group was hospitalized (30.6% vs 48.7%, respectively; difference: −18.1%; 95% CI: −40.1% to 4.0%). Patients who received ORT were as likely as those who received IVF to prefer the same therapy for the next episode of gastroenteritis (61.3% vs 51.4%, respectively; difference: 9.9%; 95% CI: −14% to 33.7%).
Conclusions This trial demonstrated that ORT is as effective as IVF for rehydration of moderately dehydrated children due to gastroenteritis in the emergency department. ORT demonstrated noninferiority for successful rehydration at 4 hours and hospitalization rate. Additionally, therapy was initiated more quickly for ORT patients. ORT seems to be a preferred treatment option for patients with moderate dehydration from gastroenteritis.
Comment Evidence has been accumulating that oral rehydration therapy (ORT) is not inferior to intravenous therapy (IVT) and is more cost effective;1, 2, 3 however, for many reasons ORT is still underused in developed nations. This well-designed RCT is an important addition to the evidence as it demonstrates the non-inferiority in a North American Pediatric Emergency Department, the setting where ORT has had difficulty gaining acceptance. This study was of high quality because its authors noted and improved upon the limitations of studies previously done in the field, as evidenced by its method of randomization, use of allocation concealment, and accounting for all patients entered into the study. While a study in this area is impossible to double blind, the authors were innovative by being the first to blind treating physicians to treatment arms. New, previously unexplored outcome measures were defined, including time to initiation of therapy and number of unsuccessful vascular accesses. The question is no longer whether ORT is safe and effective, but rather how can child health care providers ensure that children, who deserve to receive the painless and beneficial intervention of ORT, actually receive it.
References
- Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomized controlled trials. BMC Med. 2004;2(1):11
- . Enteral vs intravenous rehydration therapy for children with gastroenteritis: a meta-analysis of randomized controlled trials. Arch Pediatr Adolesc Med. 2004;158:483–490
- . Effectiveness of nasogastric rehydration in hospitalized children with acute diarrhea. J Pediatr Gastroenterol Nutr. 1995;21:145–148
PII: S0022-3476(05)00379-3
doi:10.1016/j.jpeds.2005.04.050
© 2005 Elsevier Inc. All rights reserved.
