Jemds.com Original Research Article J. Evolution Med. Dent. Sci./eISSN- 2278-4802, pISSN- 2278-4748/ Vol. 5/ Issue 69/ Aug. 29, 2016 Page 5015 TOLERABILITY OF RACECADOTRIL IN ACUTE WATERY DIARRHOEA IN CHILDREN Maha Singh 1 , Alka Yadav 2 , Sanjeev Nanda 3 1 Assistant Professor, Department of Paediatrics, SHKM Govt. Medical College, Nalhar (Mewat), Haryana. 2 Assistant Professor, Department of Paediatrics, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana. 3 Senior Professor, Department of Paediatrics, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana. ABSTRACT BACKGROUND Acute diarrhoea remains a major cause of mortality and morbidity in children due to dehydration, dyselectrolytemia and nutrient loss. Racecadotril is found to be effective in reducing the stool output in acute watery diarrhoea in children through its potent antisecretory effect mediated by enkephalinase inhibition in basolateral membrane of enterocytes and promoting selective chloride absorption through delta receptors and may prove to be beneficial in complications associated with acute watery diarrhoea. AIMS To establish the safety profile and tolerability of racecadotril. STUDY DESIGN Present study is a placebo-controlled single blind prospective study. METHODOLOGY Study was conducted in 100 children aged 6 months to 5 years having acute watery diarrhoea with some dehydration. Inclusion and exclusion criteria were strictly adhered to throughout the study. Study cohort was divided into two groups. Group A received racecadotril (1.5 mg/kg thrice a day for 5 days or till diarrhoea stopped, whichever came earlier) as adjuvant therapy to low osmolarity ORS, whereas group B received placebo and low osmolarity ORS. Variables studied were any adverse effect observed or reported by patients or parents, symptoms associated with diarrhoea such as anorexia, nausea, vomiting, abdominal pain and abdominal distension and any rebound effects after the drug was discontinued. RESULTS Both the groups were comparable clinically as well as epidemiologically. Nausea and/or vomiting was reported by 13 patients (26%) in group A and 14 patients (28%) in group B with a ‘p’ value (>0.05). Abdominal distension was reported by 3 patients in each group. None of the patients had electrolyte imbalance in either groups during the study. Abdominal pain though mild was reported by 6 patients (12%) in group A and by 5 patients (10%) in group B. None of the patients or parent reported any undesirable side effect of drug in study group. On discontinuing racecadotril rebound constipation was observed in 3 patients (6%) in group A, whereas it was observed in 2 patients (4%) in group B with ‘p’ value (>0.05). CONCLUSION Racecadotril is as tolerable as placebo and can be used as adjuvant therapy in acute watery diarrhoea in children. KEYWORDS Racecadotril, Acute Watery Diarrhoea, Enkephalinase Inhibitor. HOW TO CITE THIS ARTICLE: Singh M, Yadav A, Nanda S. Tolerability of racecadotril in acute watery diarrhoea in children. J. Evolution Med. Dent. Sci. 2016;5(69):5015-5018, DOI: 10.14260/jemds/2016/1139 INTRODUCTION Diarrhoea is the third most frequent illness seen in general practice globally with as many as four billion cases occurring each year. 1 Estimated 1.8 billion episodes of diarrhoea occur each year and 3 million children under the age of 5 years die in developing countries. 2 Overall, children are ill with diarrhoea for 10-20% of their first 3 years of life. In India during 2005, about 1.07 million cases of acute diarrhoea were reported. Prevalence of diarrhoeal episodes in India in children less than Financial or Other, Competing Interest: None. Submission 06-08-2016, Peer Review 17-08-2016, Acceptance 20-08-2016, Published 29-08-2016. Corresponding Author: Dr. Maha Singh, Assistant Professor, Department of Paediatrics, SHKM Govt. Medical College, Nalhar (Mewat), Haryana. E-mail: doc.mahasingh@gmail.com DOI: 10.14260/jemds/2016/1139 3 years continues to be as high as 19 percent. 3 In health institutions, up to a one-third of total paediatric admissions are due to diarrhoeal diseases and up to 17% of all deaths in indoor paediatric patients are diarrhoea related. 4 Diarrhoea is defined as passage of loose, liquid or watery stools at least three times in 24 hours. However, it is the recent change in the consistency of stools rather than the frequency that is more important. Another definition of diarrhoea is stool output more than 10 gm/kg/24 hours or more than adult limit of 200 gm/24 hours. Acute diarrhoea is defined as an episode of sudden onset diarrhoea, which usually lasts 3 to 7 days, but may last up to 14 days. 5 In nearly 70-80% cases of acute diarrhoea, causative agents can be identified. 6 The rotavirus is the single most important cause of diarrhoea in infants and children. 7 Most common bacterial causes of diarrhoea are Vibrio Cholerae 01, Salmonella, Shigella, Enterotoxigenic Escherichia coli and Campylobacter jejuni. Driving forces operative in diarrhoea are osmotic, secretory, exudative or motility disturbances. 8 In almost all