Effect of Domperidone on Children with Functional Abdominal Pain: A Randomized Controlled Clinical Trial

Background: One of the most common functional problems in children is functional abdominal pain (FAP), and dysmotility is one of the possible causes of FAP. Domperidone is a prokinetic drug that increases gastrointestinal motility. Objectives: The aim of this study was to evaluate the effect of domperidone on the treatment of FAP in children. Methods: In this double-blind clinical trial study, FAP was diagnosed in 80 children aged 5 - 14 years, who were referred to Amirkola Children s Hospital in Babol for one year based on the criteria of the Rome IV. Then, they were randomly divided into two groups of 40 patients. Group A received domperidone tablets (0.25 mg/kg, three-time/day) for two months, and group B received a placebo. The primary outcome was at least a 50% reduction in both frequency and severity of pain, and the secondary outcome was a significant reduction in the duration, frequency, and intensity of pain according to the Wong-Baker scale compared to baseline. Results: A total of 80 children completed the trial (40 with domperidone). The recovery rate was higher in the domperidone group than in the placebo group after eight weeks (71.8% vs. 28.2%; P 0.0001), and domperidone had significant superiority over the placebo in reducing the duration (4.58 ± 7.71 vs. 24.5 ± 41.45, min/day, P 0.001), frequency (3.35 ± 3.99 vs. 10.63 ± 10.55, episode/week, P 0.001), and intensity (2.20 ± 2.16 vs. 5.05 ± 2.37, P 0.001) of the pain. Conclusions: Based on the results, domperidone can be useful in the treatment of FAP in children.