Study of Medication for Functional Abdominal Pain in Children
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine where amitriptyline is effective in the treatment
      of functional abdominal pain in children.
    

Detailed 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.
    

Intervention name(s): Amitriptyline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Medication taken for 4 weeks; Medication taken for 4 weeks
Other intervention name(s): Other names include: Elavil, Trepiline and Laroxyl.
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: children; abdominal pain; amitriptyline