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IRCT20160308026973N2 IRCT 2021-01-08 Babol University of Medical Sciences Assesment the effect of Domperidone in the treatment of Functional Abdominal Pain in children Comparison of the Effectiveness of Domperidon with Placebo in the treatment of Functional Abdominal Pain in children 2021-01-20 anticipated 80 Complete https://irct.ir/trial/52646 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The research-aware nurse divided the samples into 2 categories using Block randomized. Both the physician and the patient will be blind to the grouping of patients (Double blind), Blinding description: After the diagnosis of FAP was given to the patients by the Pediatric Gastroenterologist and the initial questionnaires were completed by the Pediatric assistant under the supervision of the Pediatric Gastroenterologist, the patient was referred to a knowledgeable nurse for research. She will place the samples in 2 categories using Block randomized . 3 Functional Abdominal Pain. Intervention 1: Intervention group: Domperidone tablets 0.25mg / kg TDS up to 8 weeks (Hakim Pharmaceutical Company). Intervention 2: Control group: Placebo which is completely similar to Domperidone in terms of shape, appearance and color ( Faculty of Pharmacy, Sari University of Medical Sciences). Yes - There is a plan to make this available What will be shared: All data including primary (before treatment) and secondary (end of treatment) questionnaires including patients' demographic information, pain frequency, pain intensity and duration of pain can be shared after the individuals not being identified. When: Documents are available forever after the results are published. To whom: The documentation will be accessible to everyone. Conditions: It is possible to use the documents in other scientific articles and to obtain new results in different contexts while submitting a written request and agreeing to be responsible for the study response. Where to obtain: It is possible to receive documents from the Research Center of Babol University of Medical Sciences (Babol University of Medical Sciences located in Ganj Afrooz St.) or by correspondence with the person in charge of public accountability of the study via email (n.tavackoli.h@gmail.com). How to obtain: It is possible by submitting a request in person or by e-mail through the said addresses. Comments:
public Negin Tavackoli Haghighi
No 19, Amirkola Children’s Hospital, Amirkola
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 N.tavackoli.h@gmail.com Babol University of Medical Sciences scientific Sanaz Mehrabani
No 19, Amirkola Children’s Hospital, Amirkola
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 mehrabanisanaz@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) 5-14 years old children referred to Amirkola Children's Hospital with diagnosis of functional abdominal pain (FAP) 5 years 14 years Both Existence of chronic disease Taking other medications such as antibiotice and probiotic during the month before the start of the project The presence of Abdominal pain's red flags Constipation K59.9 Functional intestinal disorder, unspecified Treatment - Drugs Placebo Intervention group: Domperidone tablets 0.25mg / kg TDS up to 8 weeks (Hakim Pharmaceutical Company) Control group: Placebo which is completely similar to Domperidone in terms of shape, appearance and color ( Faculty of Pharmacy, Sari University of Medical Sciences) Change at least 50% of the frequency of pain. Timepoint: At the beginning of the study and after two months of medication (end of the study). Method of measurement: Based on the questionnaire of reducing the frequency of pain, pain intensity and duration of pain (assessment of pain intensity based on face scale questionnaires). Abdominal pain intensity based on Wong-Baker FACES Pain Rating Scale questionnaire. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Wong-Baker FACES Pain Rating Scale questionnaire. Duration of pain. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements). Pain frequency (number of pain days per month). Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements). Babol University of Medical Sciences Approved 2020-10-10 Ethics committee of Babol University of Medical Sciences No 19, Amirkola Children’s Hospital, Amirkola, Babol Mazandaran Iran (Islamic Republic of)