Randomized Double-blind Trial of Ringer Lactate Versus Normal Saline in Pediatric Acute Severe Diarrheal Dehydration.

Abstract

The aim of this study was to compare the effectiveness of Ringer lactate (RL) versus normal saline (NS) in the correction of pediatric acute severe diarrheal dehydration, as measured by improvement in clinical status and pH (≥7.35). A total of 68 children ages 1 month to 12 years with acute severe diarrheal dehydration (World Health Organization [WHO] classification) were randomized into RL (n = 34) and NS groups (n = 34) and received 100 mL/kg of the assigned intravenous fluid according to WHO PLAN-C for the management of diarrheal dehydration. The primary outcome was an improvement in clinical status and pH (≥7.35) at the end of 6 hours. Secondary outcomes were changes in serum electrolytes, renal and blood gas parameters, the volume of fluid required for dehydration correction excluding the first cycle, time to start oral feeding, hospital stay, and cost-effectiveness analysis. Primary outcome was achieved in 38% versus 23% (relative risk = 1.63, 95% confidence interval 0.80-3.40) in RL and NS groups, respectively. No significant differences were observed in secondary outcomes in electrolytes, renal, and blood gas parameters. None required second cycle of dehydration correction. Median (interquartile range) time to start oral feeding (1.0 [0.19-2.0] vs 1.5 [0.5-2.0] hours) and hospital stay (2.0 [1.0-2.0] vs 2.0 [2.0-2.0] days) was similar. The median total cost was higher in RL than NS group ((Equation is included in full-text article.)120 [(Equation is included in full-text article.)120-(Equation is included in full-text article.)180] vs (Equation is included in full-text article.)55 [(Equation is included in full-text article.)55-(Equation is included in full-text article.)82], P ≤ 0.001). In pediatric acute severe diarrheal dehydration, resuscitation with RL and NS was associated with similar clinical improvement and biochemical resolution. Hence, NS is to be considered as the fluid of choice because of the clinical improvement, cost, and availability.