CLINICAL OUTCOME WITH ADD ON RACECADOTRIL VERSUS STANDARD CARE IN PAEDIATRIC GASTROENTERITIS – OUR EXPERIENCE
Journal Title: Journal of Evidence Based Medicine and Healthcare - Year 2016, Vol 3, Issue 12
Abstract
BACKGROUND Acute gastroenteritis (AGE) is a diarrheal disease of rapid onset, with an increase in the water content, volume, or frequency of stools and often self-limiting. The WHO recommends ORS as the treatment of choice for children with mild to moderate gastroenteritis in both developed and developing countries. Racecadotril, an intestinal enkephalinase inhibitor, has been used as treatment because it would decrease the duration of acute diarrhea and fluid loss. Racecadotril has sufficient proven efficacy in the treatment of acute diarrhea in children. We evaluated the clinical outcome with add on Racecadotril versus standard care in paediatric gastroenteritis. METHODS This open-label randomized study was undertaken at department of Pediatrics, Medical College, for a period of two years. A total 42 children, age group between 3- 10 years of age having watery non-bloody diarrhea with mild to moderate dehydration were enrolled in the study. Patients with severe dehydration, bloody diarrhea or hypersensitivity to Racecadotril were excluded from the study. The patients were randomly assigned to receive intravenous rehydration therapy + Racecadotril (1.5mg/Kg) three times a day or intravenous rehydration therapy alone. The bedside nurse or care giver was instructed to administer the medication. All patients received standardized follow - up care for 7 days. The primary outcomes recorded were percentage of patients having diarrhea, median Stool frequency and percentage of patients switched to complete oral re-rehydration on day 3 and day-7. RESULTS Out of 42 children in each group whose data were analyzed, 27 patients received intravenous rehydration therapy + Racecadotril (1.5mg/Kg) three times a day and remaining 15 received intravenous rehydration therapy alone. All patients were age and gender matched, however percentage of patients who were moderately dehydrated were marginally higher in Racecadotril add on group. More than 50% reduction in stool frequency was seen in Racecadotril group. Percentage of patients having diarrhea and percentage of patients who were switched to complete oral re-rehydration therapy were significantly higher in Racecadotril add on group than standard care on day-3. However, outcome variables were similar on day- 7. CONCLUSION Add on Racecadotril to intravenous rehydration therapy acutely reduces stool frequency and switch children to complete oral rehydration therapy as compared to intravenous therapy alone. However cost effectiveness has to be addressed in large sample size studies.
Authors and Affiliations
Vijayalakshmi P, Veeresh S. M
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