The Efficacy and Safety of Enkephalinase Inhibitor Racecadotril in Treatment of Acute Diarrhea in Children: A Randomized Clinical Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 95 participants or records.
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