Study of Medication for Functional Abdominal Pain in Children
Study of Medication for Functional Abdominal Pain in Children
The purpose of this study is to determine where amitriptyline is effective in the treatment
 of functional abdominal pain in children.
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.
Inclusion Criteria:

 -  Age 8 to 17 years

 -  Diagnosis of functional abdominal pain or irritable bowel syndrome made by a pediatric
 gastroenterologist according to Rome II criteria

 -  Mean daily intensity of pain of 25 mm in the week prior to the initiation of the
 study, based on the Word-Graphic Rating Scale continuous score

 -  Following evaluation in the six months prior to the study: normal EKG and laboratory
 tests including complete blood count, erythrocyte sedimentation rate, albumin, serum
 amylase, lipase, liver enzymes, urine analysis, stool examination for occult blood and
 ova and parasites. Urinary culture will be obtained if the symptoms or urinalysis
 suggest the possibility of a urinary infection,

 -  Normal lactose breath test or history of lack of resolution of symptoms on a
 lactose-free diet

 -  Consenting parents

 -  Patient assent

 Exclusion Criteria:

 -  Inclusion criteria not met

 -  Evidence of organic gastrointestinal disease, hepatic disorders, urinary or cardiac
 disease, seizures, blood dyscrasias, glaucoma

 -  History of allergic reaction to amitriptyline

 -  Patients receiving barbiturates, cimetidine, neuroleptics, monoamine oxidase
 inhibitors, sympathomimetic agents or quinidine

 -  Children below the 5th percentile for weight or height

 -  Hemoccult positive stools