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

In this study, 100 children with the diagnosis of functional abdominal pain who are eligible for the study are chosen from a pediatrics gastroenterology private clinic. They are then randomly assigned into two groups of intervention and control and receive buspirone or placebo. Medications are placed in bottles that are divided by a pharmacist through a randomization software and each bottle have a code. This trial is a Phase 3 clinical trial.

In this study patients are recruited from a pediatrics gastroenterology private clinic, based on the inclusion criteria that has been explained in the study protocol. At first, patients will be observed for one week for type of their symptoms and pain severity without using any medications. Then patients would receive placebo or buspirone which are in matte bottles, randomly for 4 weeks. These bottles are classified randomly through the randomization software by a pharmacist. In each arm of the study, 50 patients are involved based on the statistical calculations. To determine the efficacy of buspirone and to compare its efficacy with placebo, two primary and secondary outcomes are defined. Primary outcome measure treatment response as pain relief in patients using Wong-Baker faces pain rating scale (WBFPRS). Secondary outcome measures the amount of changes in depression severity, anxiety, somatization, sleep quality and clinical impression of severity and improvement from the physician’s point of view through The Children’s Depression Inventory (CDI), Revised children’s manifest anxiety scale TM(RCMASTM), Children’s Somatization Inventory-Revised Form (CSI-24), The Sleep Disturbance Scale for Children (SDSC) and Clinical Global Impression Severity and Improvement scales (CGI-S, CGI-I) respectively. Primary and secondary outcomes are measured before starting the intervention, 4 weeks after the start point and finally 8 weeks after the end of the intervention. Side effects also would be evaluated using a checklist, two weeks after using medication through telephone calls and also 4 weeks after the start point during visiting the patient.

Inclusion criteria: 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 Exclusion criteria: 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

Intervention group: In this group 50 patients who are randomly chosen would receive buspirone. Control group: In this group 50 patients who are randomly chosen would receive placebo.

Primary outcome measure treatment response as pain relief in patients using Wong-Baker faces pain rating scale (WBFPRS). Secondary outcome measures the amount of changes in depression severity, anxiety, somatization, sleep quality and clinical impression of severity and improvement from the physician’s point of view through The Children’s Depression Inventory (CDI), Revised children’s manifest anxiety scale TM(RCMASTM), Children’s Somatization Inventory-Revised Form (CSI-24), The Sleep Disturbance Scale for Children (SDSC) and Clinical Global Impression Severity and Improvement scales (CGI-S, CGI-I) respectively.

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.

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.