Efficacy and safety of non-specific anti-diarrheal agents in the management of acute diarrhea in children.

Abstract

Objective: To compare the efficacy and safety of racecadotril, smectite and placebo among children having acute diarrhea. Study Design: Randomized Controlled trial. Setting: Department of Pediatrics, Allama Iqbal Memorial Teaching Hospital, Sialkot. Period: January 2021 to June 2021. Material & Methods: A total of 120 children (40 in each group) of both gender, aged above 6 months to 5 years with acute diarrhea were enrolled. All children were prescribed oral rehydration therapy (ORT). As co-adjuvant treatment, children in Group-A (n=40) were prescribed smectite, racecadotril in Group-B (n=40) while placebo was given in Group-C (n=40). Among all children, treatment duration was 7 days and all children were asked to follow up on 3^rd, 5^th and 7^th day for the evaluation of stool frequency, stool consistency and dehydration status. Results: In a total of 120 children, 62 (51.7%) were male. Overall, mean age was noted to be 17.9+9.4 months. Stool frequency significantly reduced in Group-A and Group-B in comparison to Group-C at day-3 (p<0.001), day-5 (p<0.001) and day-7 (p=0.018). During the follow ups, need for IV rehydration was 1 (2.5%) in Group-A, 1 (2.5%) in Group-B and 6 (15.0%) in Group-C (p=0.035). Significant improvement was observed in stool grading of children in Group-A and Group-B when compared to Group-C at day-3 (p<0.001), day-5 (p<0.001) and day-7 (p=0.043). No side effects were recorded in any of the patients. Conclusion: Along with oral rehydration therapy, non-specific anti-diarrheal agents like smectite and racecadotril were found to have good efficacy and safety in the management of acute diarrhea in children.