Functional abdominal pain. Unspecified abdominal pain
Conditions
Interventions
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 grou
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 .
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactOmid Yaghini
Esfahan University of Medical Sciences
Outcome results
None listed