Track topics on Twitter Track topics that are important to you
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Functional Gastrointestinal Disorders
Children's Memorial Hospital
Children's Memorial Hospital
Published on BioPortfolio: 2014-08-27T03:34:52-0400
This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gas...
This cross-sectional survey study is to determine the prevalence of functional gastrointestinal (GI) disorders in the general population and to describe common triggers for food-related GI...
A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrom...
To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-...
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treati...
This prospective study evaluated the incidence of functional gastrointestinal disorders (FGIDs) during infancy, on their own or combined with other symptoms.
The goal of this review is to review the current status of prokinetics and to place it in historical context. Impaired motility and thus propulsion have long been thought to play important roles in th...
The most common medical conditions in infants, which belong to pediatric and gastroenterological disease areas, are functional gastrointestinal disorders, food hypersensitivity and food allergy. First...
The most common functional gastrointestinal disorders (FGID) are functional dyspepsia (FD) and irritable bowel syndrome (IBS), with a prevalence in the general population of 15-20% (FD) and 10% (IBS),...
To test the hypothesis that allergic proctocolitis, a cause of self-limiting rectal bleeding in infants, can predispose to the development of functional gastrointestinal disorders (FGIDs) later in chi...
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.
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)
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)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Pathological processes that affect voice production, usually involving VOCAL CORDS and the LARYNGEAL MUCOSA. Voice disorders can be caused by organic (anatomical), or functional (emotional or psychological) factors leading to DYSPHONIA; APHONIA; and defects in VOICE QUALITY, loudness, and pitch.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...