Abdominal pain predominant functional gastrointestinal disorders in children
Conditions
Interventions
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 b
Sponsors
none
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Clinical or laboratory evidence suggesting organic pathology Chronic medical or surgical disease other than FGD Long-term medication for any illness other than FGD Previous abdominal surgery except appendectomy Use of prokinetic drugs or any other drugs that can alter gastrointestinal motility during the within 30 days prior to the diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 [8 weeks after the intervention] 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. [8 weeks after the intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) [At baseline and at 8 weeks after commencement] Decrease impact on the family using the PredsQL Family Impact Module - version 2, parent report will be used [At baseline and at 8 weeks after commencement ] 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 [At baseline and at 8 weeks after commencement ] Tolerability of intervention: any specified, severe or unexpected adverse reactions among all those allocated study treatment compared to placebo [At baseline and at 8 weeks after commencement ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Shaman Rajindrajith
Senior Lecturer and Consultant Paediatrician
Outcome results
None listed