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ECMT January 2007 Michael Vloeberghs Professor of Paediatric Neurosurgery Nottingham University Hospital

Intrathecal Baclofen in Children with CP and Dystonia The NUH Experience. . BASICS. GABA: inhibitory neurotransmittorBaclofen: increases the effect of GABA in the nervous systemDeveloped in 1920Intrathecal use since 1970'sDrug delivery systems since 1980's. HOW. Programmable implantable pump,

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ECMT January 2007 Michael Vloeberghs Professor of Paediatric Neurosurgery Nottingham University Hospital

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    1. ECMT January 2007 Michael Vloeberghs Professor of Paediatric Neurosurgery Nottingham University Hospital

    2. Intrathecal Baclofen in Children with CP and Dystonia The NUH Experience

    3. BASICS GABA: inhibitory neurotransmittor Baclofen: increases the effect of GABA in the nervous system Developed in 1920 Intrathecal use since 1970s Drug delivery systems since 1980s

    4. HOW Programmable implantable pump, Synch II Catheter, going from pump to spinal sack Baclofen is delivered near the spinal cord The dose necessary for effect is 1/1000 of the oral dose Limited by reservoir volume

    5. WHO Proven benefit: Quadriparetics with severe spasticity Unproven benefit: Ambulant patients Historically: ITB in children was seen as experimental in 1998 Postcode lottery, funding restrictions, various hurdles

    6. EFFECTS Improvement of nursing care Improved interactivity Improved swallowing Improved ease of motion Improved function? Effect lies in the eye of the beholder The test procedure is predictive of outcome

    7. Nottingham Activity Referral Test Procedure, EUA (neuromuscular block) Negotiation Phase Implant Refill Procedure 10/1998 First tests & implants started

    8. Test Procedure- Effects Improvement of nursing care Improved interactivity Improved swallowing Improved ease of motion Improved function? Effect lies in the eye of the beholder The test procedure is predictive of outcome Clear goals Negotiation

    9. ITB Implant Programmable implantable pump, Medtronic Synchromed II Catheter, going from pump to spinal sack Baclofen is delivered near the spinal cord The dose necessary for effect is 1/1000 of the oral dose Limited by reservoir volume

    11. TEST PROCEDURE Examination under anaesthetic, catheter insertion, single injection of 50 mcgs ITB Total tests: 164 No effect of Baclofen: 12 Good effect of Baclofen, implant declined: 15 No adverse events No side effects No infections 10% spinal tap syndrome Awaiting funding: > 50

    12. NUH Implants 147 implants in 137 children 127 CP, birth-injury-prematurity 8 Dystonia 2 Familial Paraparesis 2 Transverse Myelitis 1 TBI 1 NAI 1 Near Drowning 1 Encephalitis

    13. Distribution Male: 80 Female: 57 Subcutaneous: 5 Subfascial: 142 Synchromed EL 10 ml: in use 66 Synchromed II 20 ml: 81 Single piece catheter Tip position irrelevant Cervical catheter implant 4

    14. Dystonia Primary : 6 2 PKAN 2 Unknown 1 Glutaraciduria 1 Leys syndrome 3 have DBS in place Secondary : 2 Posturing Bulbar signs Athetoid

    15. ADVERSE EVENTS Catheter migration : 16 per procedure: 10,1% Fracture catheter connector: 5 (EL) 3,4% Infection: 3 + 1 (1 sterile pus) 2,7% Cut catheter 2, 1 spin proc., 1 iatrogen. Psychosis: 1 GI Side effects on dose increment: 1 Sedation: 1 Death unrelated to ITB: 5 UNK: 1 TOR: 6 End Battery Life: 2 Minor events: small number without consequence No adverse events with refills,1998- 2006 No adverse events with Cervical Catheter test or implant.

    16. CONCLUSION ITB is safe, has a number of adverse events but these lie well in the brackets of the international literature NUH has the largest global experience with ITB in Children The ITB team aims to improve the service and continue to collect data on ITB

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