Use of domperidone in children with abdominal pain

INTERVENTION: The intervention group will receive domperidone 10mg as oral tablets (brand name Motilium®) 3 times per day 15 minutes before meals, while control group receives a placebo 3 times per day 15 minutes before meals for 8 weeks. A diary will be provided to document severity, frequency and duration of symptoms and interruption of activities. Gastric motility studies will be repeated at 8th week CONDITION: Abdominal pain predominant functional gastrointestinal disorders in children PRIMARY OUTCOME: 1.Cure ; i.Less than 4 episodes of abdominal pain per month; ii.Severity of abdominal pain less than 25mm in the visual analogue scale; iii.No interruption of activities due to abdominal pain; ; 2.Improvement : based on responses to 2 questions; i.Overall how do you feel your problem is? Answer will be better, same or worse. “Better” will be regarded as positive result. “Same” or “worse” will be regarded as negative result; ii.How did the medication relieve your pain? Sense of improvement will be expressed as excellent, good, fair and poor. Excellent and good will be considered as positive result. fair and poor will be considered as negative result. SECONDARY OUTCOME: 1.Improvement of quality of life using the PredsQL Paediatric Quality of Life Inventory ‐ version 4 for young child report (ages 5 ‐ 7 years) and child report (ages 8 ‐12 years) ; 2.Decrease impact on the family using the PredsQL Family Impact Module ‐ version 2, parent report will be used ; 3.Improvement of gastric motility using gastric emptying rate and antral motility index. An increase of 25% or more from baseline in the above motility parameters will be considered as improvement ; 4.Tolerability of intervention: any specified, severe or unexpected adverse reactions among all those allocated study treatment compared to placebo INCLUSION CRITERIA: Age between 5‐12 years Children who fulfil the Rome III criteria for abdominal pain related FGD Children with abdominal pain at least once per week for at least 2 months prior to diagnosis Pain severity more than 25% on visual analogue scale pain interrupt the activities of the child (e.g. sleep, play, schooling etc) Written informed consent from parents or legally‐accepted guardians