Study of Medication for Functional Abdominal Pain in Children
Summary
The purpose of this study is to determine where amitriptyline is effective in the treatment of functional abdominal pain in children.
Description
Recurrent gastro-intestinal complaints constitute one of the most common reasons for medical consultation among daycare and school children. Studies suggest an association between childhood functional abdominal pain and psychiatric disorders. Although most children with mild symptoms are mostly managed by reassurance and simple measures, a large range of interventions such as dietary changes, use of antidepressant and medications are being widely used with little evidence to suggest their effectiveness. In view of the high prevalence of this disorder and the lack of pediatric scientific evidence on extensively used drug therapies there is critical need to develop trials of all suggested pharmacologic interventions in children with functional pain disorders. This study has the potential to fill a critical void in pediatric gastroenterology.
The main objective of this study is to evaluate the impact of the medication (amitriptyline) on symptoms of patients with abdominal pain of non-organic origin.
Our hypotheses are that amitriptyline results in adequate relief of symptoms in children with functional abdominal pain and that is more effective than placebo in controlling pain.
This is a randomized, double masked placebo controlled study, using standard current measures and diagnostic criteria to address the question whether the treatment with amitriptyline is efficacious, and that leads to an improvement in severity of the symptoms for which the patient sought medical attention.
The study is conducted on a group of children (eight to eighteen years) suffering from functional abdominal pain. The study population is randomly assigned (by chance) into 2 groups (half of the patients receive drug and half of patients receive a non-acting drug-placebo). Each individual will randomly receive the medication or placebo at night time for 4 weeks. In order to qualify for the study the patients have to complete one week on baseline questionnaires to assess their symptoms and have to be diagnosed with a condition associated with functional abdominal pain by the investigators. The patient will complete initial questionnaires and end of the study questionnaires as well as daily questionnaires to assess the symptoms. At the end of the study both groups will be compared to establish differences.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Functional Gastrointestinal Disorders
Intervention
Amitriptyline, Placebo
Location
Children's Memorial Hospital
Chicago
Illinois
United States
60614
Status
Completed
Source
Children's Memorial Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00564525
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:34:52-0400
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Medical and Biotech [MESH] Definitions
Amitriptyline
Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
Cisapride
A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)
Hypokalemia
Abnormally low potassium concentration in the blood. It may result from potassium loss by renal secretion or by the gastrointestinal route, as by vomiting or diarrhea. It may be manifested clinically by neuromuscular disorders ranging from weakness to paralysis, by electrocardiographic abnormalities (depression of the T wave and elevation of the U wave), by renal disease, and by gastrointestinal disorders. (Dorland, 27th ed)
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Opipramol
A tricyclic antidepressant with actions similar to AMITRIPTYLINE.
