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IRCT20190522043672N5 IRCT 2023-05-17 Mashhad University of Medical Sciences The effect of bethanechol and domperidone on oral feeding intolerance A comparative study of the effect of bethanechol and domperidone on food tolerance in children with food intolerance 2023-05-22 anticipated 214 Complete https://irct.ir/trial/69758 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequence generation will be done using www.randomization.com. Codes A and B are considered for patients, and allocation concealment will be done using opaque sealed envelopes, Blinding description: The statistical consultant, the data analyst, the patients, and the outcome assessor are blinded. As the patients are children, they have no knowledge and information about the type of intervention. After obtaining informed consent from their parents, they have been classified into intervention groups. The evaluator who records the patient's clinical outcomes has no information about the type of intervention. Because the intervention is given by a nurse or doctor, the person registering does not know about the type of intervention. For the statistical consultant, the type of intervention is coded. 3 Malabsorption due to intolerance. Intervention 1: Intervention group1: Domperidone in children 0.25 to 0.5 mg/kg, orally 3 or 4 times a day. Intervention 2: Intervention group 2: Children receive bethanechol orally at 0.5 mg/ kg/ day in 3 divided doses with a maximum dose of 10 mg per dose. It is taken 1 hour before or 2 hours after food. Yes - There is a plan to make this available What will be shared: The main and secondary outcome can be shared. When: Six months after the results are published To whom: Researchers affiliated with academic centers Conditions: For the use of researchers affiliated with academic centers for scientific studies Where to obtain: Dr.Majid Sezavar How to obtain: Request via email to sezavardm@mums.ac.ir Comments:
public Majid Sezavar
Akbar Children's Hospital, in front of Shahid Kaveh 14, Shahid Kaveh Boulevard
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Sezavar
Akbar Children's Hospital, in front of Shahid Kaveh 14, Shahid Kaveh Boulevard
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) One month to 18 year children, hospitalized in the pediatric intensive care unit Patients with nutritional intolerance 1 month 18 years Both The cause of intolerance is one of the remediable causes such as electrolyte disorder, constipation or ileus K90.4 Malabsorption due to intolerance, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group1: Domperidone in children 0.25 to 0.5 mg/kg, orally 3 or 4 times a day Intervention group 2: Children receive bethanechol orally at 0.5 mg/ kg/ day in 3 divided doses with a maximum dose of 10 mg per dose. It is taken 1 hour before or 2 hours after food. Nutritional tolerance. Timepoint: Daily review from the first day of intervention. Method of measurement: Specialist clinical examinations. Possible side effects during hospitalization. Timepoint: Daily examination during hospitalization. Method of measurement: Clinical examination by experts. Mashhad University of Medical Sciences Approved 2023-02-14 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)