Recurrent Abdominal Pain in Childhood -Characteristics and Course

Abdominal Pain Clinical Trial

Official title:

Recurrent Abdominal Pain in Childhood, Characteristics and Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311233
• Other study ID #: 150063
• Status: Completed
• Phase: N/A
• First received: April 3, 2006
• Last updated: May 22, 2008
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Eastern Norway Regional Health AuthorityNorway: Innlandet Hospital, Health AuthoritiesNorway: Centre for Child and adolescent Mental Health, Eastern and Southern Norway
• Study type: Observational

Clinical Trial Summary

Recurrent abdominal pain (RAP) is a common complaint in childhood. Identification of the processes that maintain illness is important.

The purpose of this study is to get more knowledge about characteristics of children with recurrent abdominal pain and their parents, and about the course of their pain. These results may be important to identify children who need treatment.

Description:

BACKGROUND:

Recurrent abdominal pain (RAP), mainly constituted by functional gastrointestinal disorders (FGID), affects a significant number of children, and is a result of a complex interaction between biopsychosocial factors. Despite the seemingly benign nature of RAP, in some children RAP is associated with school absenteeism, functional impairment and frequent doctor visits. Identification of the processes that maintain illness is important. These results may be important to identify children who need treatment.

AIMS:

The aims of this study are to characterize children with RAP (in four out-patient clinics) and their parents, describe outcome and determine predictors of persistent RAP in children.

SAMPLE:

150 pediatric patients (4-15 years), their parents and teachers. Consecutive new patients referred to four pediatric out-patients clinics for evaluation of abdominal pain (primary complaint). Patients with RAP (abdominal pain at least once a month, in three consecutive months during the last year, and whose pains are severe enough to affect daily activity) are eligible.

DESIGN: A prospective cohort study.

MEASUREMENT:

All pediatric patients will undergo a complete physical examination emphasizing diagnosing organic illness and FGID according to the international ROME classification. Routine laboratory will be done. A protocol to identify somatic causes is part of the study. In addition, parents will complete validated questionnaires regarding their child`s physical/psychological health, temperamental characteristics and social skills and also psychosocial conditions concerning them selves. Self-report regarding the same aspects will be obtained from children above 8-9 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

Inclusion Criteria:

• Consecutive new pediatric patients (4-15 years) referred by their general practitioners to four pediatric out-patient clinics in Innlandet Hospital Health Authorities for evaluation of recurrent abdominal pain.

Exclusion Criteria:

• Known organic diagnosis for abdominal pain

• Language problems (which will interfere completing questionnaires)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Pain

Locations

Country	Name	City	State
Norway	Division of women and child and Division of Child and Adolescent Psychiatry, Innlandet Hospital Health Authorities	Gjovik

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Regionsenter for barn og unges psykiske helse

Country where clinical trial is conducted

Norway,