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The Efficacy and Safety of Enkephalinase Inhibitor Racecadotril in Treatment of Acute Diarrhea in Children: A Randomized Clinical Trial

Background: Acute diarrhea in children with an annual prevalence of about 2 billion episodes accounts for 1.9 million deaths in developing countries. According to the World Health Organization (WHO), only 35% of children with diarrhea receive proper treatment for dehydration; hence, the detection of appropriate interventions enables us to prevent mortality and decrease the morbidity rate. Methods: This prospective randomized clinical trial was conducted from September 2018 to May 2019 in the Pediatric Gastroenterology Ward at the Mofid Children's Hospital, where 95 children were hospitalized with non-exudative acute gastroenteritis and moderate to severe dehydration. Among these patients, 53 children were administered intravenous (IV) fluid therapy and oral rehydration solution (ORS), and 42 children received IV rehydration and ORS plus Racecadotril (ORS+R). Daily bowel movements and their consistency were recorded at admission, 24 hours, and 48 hours after hospitalization. All data were analyzed by SPSS software version 25. Results: There was no statistically meaningful difference between the intervention and control groups in terms of age, gender, and weight. According to the statistical analysis, the dehydration severity was same in both groups, and no difference was revealed between the two groups regarding fever and vomiting. All laboratory findings were similar in both groups at the time of admission. Although the average duration of diarrhea was shorter in the racecadotril group than in the control group, there was no statistically significant difference between the two groups. The results indicated a rapid decline in the number of bowel movements by the first and second days after beginning of the treatment in both groups; however, no statistically meaningful difference was noticed. The present results indicated no significant difference between the two groups regarding the recovery rate in the first 24 hours of treatment. Moreover, although the recovery rate of children treated for 48 hours was faster in the racecadotril+ORS group than in the oral rehydration group, no significant difference was revealed. Conclusions: There was no meaningful relationship between the administration of racecadotril with the duration of diarrhea, the frequency of diarrhea, and the recovery rate in the first and second days after treatment. However, in 24 and 48 hours after treatment, there were a decrease in the number of watery stools and an increase in solid stools; hence, further studies with larger sample sizes and more accurate measurements determining factors affecting acute diarrhea and differentiating different types of diarrhea are recommended to further illustrate the role of racecadotril on the treatment of diarrhea in children.