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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.

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Presentation on theme: "Randomised, placebo controlled, double blind, crossover study of the efficacy and side effects of amitriptyline in children 6-18 years old with EB Richard."— Presentation transcript:

1 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

2 Background Pain – wounds – wound care – infection Immobility – pain – wound healing and contracture formation

3 Pain pathophysiology and management in EB Inflammatory Neuropathic Paracetamol/ NSAIDS Opioids Anti-epileptics Anti-convulsants Anti-depressants

4 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

5 Funding 2 years F/T Research Nurse Study expenses

6 Design DBRCT Placebo controlled Crossover –2 x 6 weeks treatment periods Pain, Mobility, QOL, Side effects

7 Study Flow Chart

8 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

9 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’

10 Outcomes Pain QOL Gait/ mobility Side effects

11 Outcomes Pain QOL Gait/ mobility Side effects

12 Pain Baseline and after 5 weeks treatment 7 days twice daily VAS – at rest – activity

13 Outcomes Pain QOL Gait/ mobility Side effects

14 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: – 8 activities chosen from list: scored 0-4 e.g. going to school; watching TV; eating Scored: Not difficult-Extremely difficult

15 Outcomes Pain QOL Gait/ mobility Side effects

16 Mobility GAITRite Standard Functional Measure by Physiotherapist

17 Walkway connections

18

19 Outcomes Pain QOL Gait/ mobility Side effects

20 Secondary Outcomes Cardiovascular – ECG – Echocardiogram Anticholinergic – Sedation – Dry mouth – Blurred vision Other

21 Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment

22 Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment

23 Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment

24 Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment

25 Problem Placebo unavailable – Start of trial delayed – Research Nurse already in post Solution – Re-approach to funder – Applied for ‘Study adoption’

26 Problems Trials in children Small population Unforeseen delays Funding problems Slow recruitment

27 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

28 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

29 Questions?


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