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J Pediatr Gastroenterol Nutr. 2018 May;66(5):725-731. doi: 10.1097/MPG.0000000000001819.

Randomized Controlled Clinical Trial on Value of Domperidone in Functional Abdominal Pain in Children.

Author information

1
Department of Physiology, Faculty of Medicine, University of Ruhuna, Galle.
2
Department of Physiology.
3
Department of Pharmacology.
4
Department of Pediatrics, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.

Abstract

OBJECTIVES:

The aim of the study was to evaluate the therapeutic effect of domperidone on children with abdominal pain predominant functional gastrointestinal disorders (AP-FGIDs).

METHODS:

One hundred children (aged 5-12 years) fulfilling Rome III criteria for AP-FGIDs were randomized into 8 weeks of domperidone or placebo treatment. Primary outcomes defined were cure and patient-reported general improvement. Secondary outcomes were reduction in the severity of abdominal pain and increase in gastric motility. Patients were followed up for 6 months.

RESULTS:

Eighty-nine (42 in placebo group, 47 in domperidone group) completed the trial at 8 weeks. Seventy-nine completed the 6-month follow-up. When primary outcomes were assessed at 8 weeks, 37 (74%) in the domperidone group and 25 (50%) in the placebo group showed patient-reported general improvement (P = 0.013), whereas no significant difference was observed in cure (22 [44%] vs 14 [28%] P = 0.09). At 6-month follow-up 30 (60%) in the domperidone group and 19 (38%) in the placebo group reported cure (P = 0.028), whereas 44 (88%) in the domperidone group and 33 (66%) in the placebo group showed patient-reported general improvement (P = 0.009). When assessing secondary outcomes at 8 weeks, the domperidone group reported significant reduction in the severity of abdominal pain (54.1% vs 24.7%, P = 0.008) and an increase in the antral motility index (27.5% vs 7.2%, P = 0.029). None of the patients reported intervention-related adverse effects.

CONCLUSIONS:

Domperidone may be a safe and effective therapeutic modality to achieve a lasting remission of symptoms in children with AP-FGIDs.

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