Safety and Efficacy of Racecadotril in Acute Watery Diarrhea: A Randomized Controlled Trial in Children Aged 3 –59 Months
DOI:
https://doi.org/10.51985/Keywords:
Racecadotril; Acute watery diarrhea; Antisecretory; Oral rehydration therapy; Randomized controlled trialAbstract
Objective: To evaluate the efficacy and safety of racecadotril (1.5 mg/kg thrice daily) in combination with standard oral rehydration therapy (ORT) and compare with placebo plus ORT in 3 - 59 months old hospitalized children with acute watery diarrhea
Study Design and Setting: A randomized controlled trial having registration number NCT07392931 was conducted with 200 children aged 3-59 months hospitalized with AWD at the Punjab Rangers Teaching Hospital in Lahore, as a prospective, double-blinded study. Participant enrolment and follow-up covered six consecutive months (1st June to 30th November 2025). The study protocol was approved by the Institutional Review Board (IRB) of Punjab Rangers Teaching Hospital, Lahore (Ref: PRTH/IRB/2023/63).
Methodology: Children either received Racecadotril (1.5mg/kg three times a day) or a placebo, with standard oral rehydration therapy. The key outcomes were the number of stools in 24 hours and the length of stay of the children in the hospital. Results: Day 1 (3.1 vs. 4.8) Racecadotril reduced the stool count. The proportion of children who achieved treatment success (a decrease in stools) on the drug compared to placebo was 82% and 48%, respectively (NNT=3). The children who were administered Racecadotril spent 26.4 hours less in the hospital. The adverse effects were rare (8% vs. 12%) and no drug-related or serious problems were observed. The cost analysis showed a savings of 6,230 PKR per patient. Conclusion: Racecadotril is safe, effective, and cost-effective. It promptly reduces stool output and hospital stay of children with AWD regardless of their age and dehydration condition.
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