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.