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IRCT20140304016844N3 IRCT 2018-01-15 Esfahan University of Medical Sciences Comparison of the efficacy of Buspirone and placebo in functional abdominal pain in children Comparison of the efficacy of Buspirone and placebo in functional abdominal pain in children 2018-01-20 anticipated 100 Complete https://irct.ir/trial/28800 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Buspirone and placebo containing drug bottles will be coded by a pharmacist using random numbers in four blocks (generated by software). Allocation will be concealed and the attending physician, participants, and outcome assessor would be unaware of the drug codes, Blinding description: In this study, patients, investigators and treating physician and also the person who helps children filling their forms do not know if they are receiving placebo or buspirone. 3 Functional abdominal pain. Intervention 1: Intervention group: This group receive buspirone 5 milligrams tablets from Tehran Darou company based on their age and the dosage would increase gradually. Intervention 2: Control group: This group receive placebo tablets that are similar to buspirone tablets and in this group also number of using tablets would increase gradually . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Participants data will be published upon the journal's request
public Omid Yaghini
Isfahan University of medical sciences, Hezar Jarib St, Azadi square, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 313668004248 yaghini@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hossein Saneian
sfahan University of medical sciences, Hezar Jarib St, Azadi square, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 313668004248 saneian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children from 6 to 18 Filling the proposed Rome III diagnostic criteria for functional abdominal pain Having written consent from the parents of these children before their entry to the study 6 years 18 years Both Using any kind of psychiatric, antibiotic or probiotic medication in last 2 months A history of symptoms improvement following 2 weeks of lactose free diet Positive result in lactose respiratory test Suffering from another digestive disorder or organic disease, in addition to functional abdominal pain Weight of Height below 5 percentile for appropriate age R10.9 Unspecified abdominal pain Treatment - Drugs Placebo Intervention group: This group receive buspirone 5 milligrams tablets from Tehran Darou company based on their age and the dosage would increase gradually Control group: This group receive placebo tablets that are similar to buspirone tablets and in this group also number of using tablets would increase gradually . Primary outcome is treatment response as pain relief in patients. Timepoint: Primary outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: Wong-Baker faces pain rating scale. Changes in depression severity. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: The Children’s Depression Inventory (CDI). Changes in anxiety severity. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: Revised children’s manifest anxiety scale TM(RCMASTM). Changes in somatization severity. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: Children’s Somatization Inventory-Revised Form (CSI-24). Changes in sleep quality. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: The Sleep Disturbance Scale for Children (SDSC). Clinical impression of severity from the physician’s point of view. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: Clinical Global Impression Severity scale (CGI-S). Clinical impression of improvement from the physician’s point of view. Timepoint: This outcome is measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Method of measurement: Clinical Global Impression Improvement scale (CGI-I). Esfahan University of Medical Sciences Approved 2017-08-18 Ethical committee of Islamic Azad University, Najafabad branch Islamic Azad University of Najafabad, Najafabad boulevard, Najafabad, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)