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Randomized Double-blind Trial of Ringer Lactate Versus Normal Saline in Pediatric Acute Severe Diarrheal Dehydration
Gayathri Bhuvaneswaran Kartha1, Ramachandran Rameshkumar, Subramanian Mahadevan
1Department of Pediatrics, Division of Pediatric Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Insights
Normal saline (NS) and Ringer lactate (RL) show similar effectiveness in treating severe pediatric dehydration. NS is recommended due to its lower cost and availability, making it the preferred choice for rehydration.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Hydration Therapy
- Gastroenterology
Background:
- Acute severe diarrheal dehydration is a significant cause of pediatric morbidity worldwide.
- Intravenous fluid resuscitation is critical for managing severe dehydration.
- Ringer lactate (RL) and normal saline (NS) are commonly used fluids, but their comparative effectiveness in pediatric severe diarrheal dehydration requires further clarification.
Purpose of the Study:
- To compare the effectiveness of Ringer lactate (RL) versus normal saline (NS) in correcting pediatric acute severe diarrheal dehydration.
- To assess clinical status improvement and normalization of blood pH (≥7.35) as primary outcomes.
- To evaluate secondary outcomes including serum electrolytes, renal and blood gas parameters, fluid volume, time to oral feeding, hospital stay, and cost-effectiveness.
Main Methods:
- A randomized controlled trial involving 68 children (1 month to 12 years) with acute severe diarrheal dehydration.
- Participants were assigned to receive either RL (n=34) or NS (n=34) at 100 mL/kg according to WHO PLAN-C guidelines.
- Primary outcome assessed at 6 hours was improvement in clinical status and pH (≥7.35).
Main Results:
- The primary outcome was achieved in 38% of the RL group versus 23% of the NS group (relative risk=1.63, 95% CI 0.80-3.40), with no statistically significant difference.
- No significant differences were observed in secondary outcomes related to electrolytes, renal function, or blood gas parameters.
- The median total cost was significantly higher in the RL group compared to the NS group (P≤0.001).
Conclusions:
- Both RL and NS are associated with similar clinical improvement and biochemical resolution in pediatric acute severe diarrheal dehydration.
- Normal saline (NS) is recommended as the fluid of choice due to its cost-effectiveness and availability.
- The study supports the use of NS for rehydration in this pediatric population, considering both efficacy and economic factors.
Objective:
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).
Methods:
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.
Results:
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).
Conclusion:
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.
