Use of domperidone in children with abdominal pain

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2012/008
• Date of registration: 07/08/2012
• Primary sponsor: None
• Public title: Use of domperidone in children with abdominal pain
• Scientific title: A study to determine the therapeutic value of the prokinetic drug- domperidone to improve gastric motility in children with abdominal pain predominant functional gastrointestinal disorders (FGD)
• Date of first enrolment: 1/9/2012
• Target sample size: 100 Children
• Recruitment status: Pending
• URL: http://www.slctr.lk/trial_details.asp?reg_id={78E7878A-3A11-477D-B637-59B7100665C2}
• Study type: Interventional
• Study design: Double blind, randomized, controlled, parallel group therapeutic; trial to assess the value of domperidone in the management of abdominal; pain predominant FGD in children

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. Shaman Rajindrajith
• Affiliation: Senior Lecturer and Consultant Paediatrician

• Name: Prof. H Asita de Silva
• Affiliation: Professor

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Abdominal pain predominant functional gastrointestinal disorders in children

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

None

Source(s) of Monetary Support

None