Efficacy and Safety of Racecadotril in Management of Acute Diarrhea in Severely Malnourished Children Under 5 Years

Abstract

Objectives

To evaluate the efficacy and safety of Racecadotril in the management of acute diarrhea in severe acute malnourished children.

Study design

Single-blinded randomized control trial

Place and duration of study

The study was conducted at the Children's Hospital and the Institute of Child Health Multan from January 1, 2019, to December 31, 2019.

Materials and Methodology

This clinical trial evaluates the efficacy and tolerance of Racecadotril in the management of acute diarrhea in children suffering from severe acute malnutrition. This was designed as a single-blinded, randomized control trial from January to December 2019 at the Children's Hospital, Multan. There were 174 children enrolled in this study, aged between 6 months and 60 months. The patients were divided into two random groups. The patients in Group A were administered standard diarrheal management according to IMNCI. IV fluids, zinc supplements, and Racecadotril were given, but Group B received all the treatments except Racecadotril. The patients were followed for stool consistency, frequency, and hydration status for 72 hours.

Result

The results indicated that both groups were not significantly different in the first 24 hours, but in the third dose after 72 hours, Group A showed dramatic improvement, as 80% of them became better hydrated with minimal diarrhea, contrasted with 70% in the Racecadotril group. On the Bristol Stool Scale and Mann-Whitney U test, the Racecadotril group showed significant recovery when the p-value was less than 0.05 with no side effects.

Conclusion

The study concludes that Racecadotril is a relatively safe adjunct treatment for SAM children with diarrheal diseases, especially after the first 72 hours of treatment.