R Sarangi, B Biswal, B Dash, A Dhanawat

Abstract

Objective: To study the tolerability and efficacy of racecadotril versus placebo in hospitalised children with acute diarrhoea. Methods: This prospective randomised placebo-controlled double blind trial was carried among 3-36 months age hospitalised children with acute diarrhoea. Out of 140 children, 67 children received placebo and 73 received racecadotril at 1.5 mg/kg, three times a day till recovery or five days whichever was earlier. Stool volume in 48 hours, duration of hospitalisation and tolerability of the drug were the outcome measures. Result: The mean stool volume in 48 hours (179.5±17.31 g/kg body weight versus 191.04±33.4 g/kg body weight, p=0.0001) and mean duration of hospital stay (62.4±11.4 hours versus 95.6±19.5 hours, p=0.0001) were significantly lower in racecadotril arm compared to placebo arm respectively. No serious adverse event was documented in either group. Conclusion: Racecadotril is both safe and effective in children with acute diarrhoea in decreasing the stool volume and duration of hospitalisation.