Double blind, placebo controlled crossover study of the efficacy and side effects of low dose amitriptyline treatment for chronic pain, disordered sleep and reduced mobility in children with Epidermolysis Bullosa

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: Child Activity Limitation Interview (CALI): In addition to classical pain measurement, using the Visual Analogue Scales (VAS), quality of life will be measured using a simple, recently developed questionnaire tool (the CALI) which defines impairments in patient selected developmentally appropriate activities. Mobility: Mobility will be assessed by a physiotherapist, with particular emphasis on quantifiable parameters of walking gait including use of the ?GAITERITE? commercial measurement system. Side effects: Side effects will be monitored, cardiovascular effects will be investigated using ECG (electrocardiograph) and echocardiography. CONDITION: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases ; Skin and Connective Tissue Diseases ; Epidermolysis bullosa PRIMARY OUTCOME: Self assessment of pain using a linear VAS SECONDARY OUTCOME: 1. Quantitative assessment of mobility, measured by a physiotherapist; 2. Reporting of sleep pattern and nocturnal pain INCLUSION CRITERIA: 1. Children age 6 ‐ 18 years 2. EB and pain 3. Not responding to conventional analgesia 4. Undergoing ongoing care at Great Ormond Street Hospital
Epistemonikos ID: 95747496e7ff65c14e90c0808e4b64f8dca7220d
First added on: Aug 22, 2024