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Randomised, placebo controlled, double blind, crossover study of the efficacy and side effects of amitriptyline in children 6-18 years old with EB Richard Howard, Jemima Mellerio and Anna Martinez Great Ormond Street Hospital for Children London WC1N 3JH
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Background Pain – wounds – wound care – infection Immobility – pain – wound healing and contracture formation
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Pain pathophysiology and management in EB Inflammatory Neuropathic Paracetamol/ NSAIDS Opioids Anti-epileptics Anti-convulsants Anti-depressants
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Amitriptyline TCA Most used anti-neuropathic in children ‘Low – dose’ 0.5mg/kg at night Empirically found to improve mobility in EB Side effects –Sedative –Anticholinergic –Cardio toxicity
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Funding 2 years F/T Research Nurse Study expenses
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Design DBRCT Placebo controlled Crossover –2 x 6 weeks treatment periods Pain, Mobility, QOL, Side effects
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Study Flow Chart
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Recruitment Target 40 Inclusion: – 6-18 years old – Pain unresponsive to conventional analgesia Exclusion: – Amitriptyline in previous 3 months –C/I to amitriptyline or TCA
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Baseline Investigations ½ day admission to hospital – Instructions on use of VAS – QOL questionnaire – Mobility assessment – Cardiovascular assessments 7 days ‘at home’ – 2x daily Pain assessment – Sleep disorder – Side effects Repeated following 5 weeks ‘treatment’
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Outcomes Pain QOL Gait/ mobility Side effects
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Outcomes Pain QOL Gait/ mobility Side effects
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Pain Baseline and after 5 weeks treatment 7 days twice daily VAS – at rest – activity
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Outcomes Pain QOL Gait/ mobility Side effects
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Quality of life Sleep disturbance – VAS daily for 7 days CALI interview – Baseline and following treatment – Child Activity Limitations Interview Palermo et al. Pain 2004; 109: 461-470 – 8 activities chosen from list: scored 0-4 e.g. going to school; watching TV; eating Scored: Not difficult-Extremely difficult
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Outcomes Pain QOL Gait/ mobility Side effects
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Mobility GAITRite Standard Functional Measure by Physiotherapist
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Walkway connections
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Outcomes Pain QOL Gait/ mobility Side effects
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Secondary Outcomes Cardiovascular – ECG – Echocardiogram Anticholinergic – Sedation – Dry mouth – Blurred vision Other
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Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment
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Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment
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Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment
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Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment
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Problem Placebo unavailable – Start of trial delayed – Research Nurse already in post Solution – Re-approach to funder – Applied for ‘Study adoption’
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Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment
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Recruitment Initial projection 40 patients in 24 months –1.7 per month – 6 patients at 12 months (0.5 per month) Solutions – Regular recruitment meetings – Protocol amendment – Develop new recruitment site – No-cost extension
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Current Progress ~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~ Recruitment rate increased from 0.5 to 1.5/ month 20 patients recruited (50%) Full data on 19 Extension obtained until end 2009 –Need 20 (21) patients in 18 months i.e. 1.2 / month
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Questions?
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