Eficacia de racecadotrilo en el tratamiento de la enfermedad diarreica aguda, en niños de 3 a 36 meses, en el servicio de emergencia del Hospital Vicente Corral Moscoso. Ensayo clínico controlado ciego. 2014.

Abstract

Objective: To determine the efficacy of the combined treatment of oral rehydration salts (ORS) and racecadotril against the use of ORS and placebo in children aged between 3 and 36 months with acute diarrhea disease (ADD), in the Vicente Corral Moscoso Hospital (VCMH) emergency service. Method: It is a blind controlled clinical trial in children from 3 to 36 months of the VCMH emergency service, with acute diarrheic disease, without dehydration or mild or moderate dehydration; they do not need hospitalization, without previous antidiarrheal treatment or antibiotic, if their parents or legal representatives sign the informed consent. A total of 79 patients were recruited, 45 in the ORS plus racecadotril group and 34 ORS plus placebo group. Results: The groups were clinically comparable, the patients in the ORS plus racecadotril group showed a significant difference in the number of diarrheas per day from 48 hours [2.7 (DS: ± 1.5), the ORS plus placebo group 4.1 (DS: ± 2.6)] with a p: 0.012; at 72 hours, the racecadotril group [2.2 (DS: ± 1.7), and placebo group [3.3 (DS: ± 2.5)] with p: 0.027. No significant difference was found in the first 24 hours (p: 0.27).

Conclusions: Racecadotril is an effective medication to reduce the number of diarrhea after 48 hours, in the initial treatment of children with ADD accompanying ORS therapy in a group of patients treated at the Vicente Corral Moscoso Hospital.