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Efficacy and Safety of Two Oral Solutions as Maintenance Therapy for Acute Diarrhea

A Double-blind, Randomized, Multicenter Trial

Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta

Paul G. Taylor, MB, FRCPC

Department of Pediatrics, Misericordia Hospital, University of Alberta, Edmonton, Alberta

Louis Geoffroy, MD, FRCPC

Department of Pediatrics, Hôpital Sainte-Justine, Université de Montreal, Montreal, Quebec

Pauline Darling, MSc

Department of Clinical Research, Ross Laboratories, Montreal, Quebec

There is continuing uncertainty about the appropriate level of sodium in oral fluid therapy for children with acute gastroenteritis in developed countries. The present study was undertaken in order to assess whether an oral glucose/electrolyte solution designed for fluid replacement (Na⁺ concentration 75 mmol/l) and an oral glucose/electrolyte solution designed for maintenance of hydration (Na ⁺ concentration 45 mmol/1) would be safe and effective in the treatment of acute childhood diarrhea in a developed country. Children aged 3-24 months (n = 54) with acute diarrhea and less than 5 percent dehydration were randomized to receive either maintenance (n . = 27) or rehydration (n = 27) fluid. Outcome was assessed at 24 and 48 hours after entry to the study. Both solutions were found to be equally effective and safe. The fluid was refused by one child in each group. Analysis of efficacy showed that hydration status was maintained in all patients and 98 percent of children showed significant improvement in diarrheal status at 24 hours. We conclude that for well-nourished ambulatory children aged 3-24 months with acute diarrhea and minimal (<5%) or no dehydration, the use of an oral fluid containing 75 mmol/l of sodium is as safe and effective as the use of an oral fluid containing 45 mmol/1 of sodium.

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