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    Safety of botulinum toxin type a for children with nonambulatory cerebral palsy

    Access Status
    Open access via publisher
    Authors
    Edwards, P.
    Sakzewski, L.
    Copeland, L.
    Gascoigne-Pees, L.
    McLennan, K.
    Thorley, M.
    Kentish, M.
    Ware, R.
    Boyd, Roslyn
    Date
    2015
    Type
    Journal Article
    
    Metadata
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    Citation
    Edwards, P. and Sakzewski, L. and Copeland, L. and Gascoigne-Pees, L. and McLennan, K. and Thorley, M. and Kentish, M. et al. 2015. Safety of botulinum toxin type a for children with nonambulatory cerebral palsy. Pediatrics. 136 (5): pp. 895-904.
    Source Title
    Pediatrics
    DOI
    10.1542/peds.2015-0749
    ISSN
    0031-4005
    School
    School of Occupational Therapy and Social Work
    URI
    http://hdl.handle.net/20.500.11937/15178
    Collection
    • Curtin Research Publications
    Abstract

    OBJECTIVE: To determine safety of intramuscular botulinum toxin A (BoNT-A) injections to reduce spasticity and improve care and comfort of nonambulatory children with cerebral palsy (CP). METHODS: Nonambulatory children with CP were randomly allocated to receive either BoNT-A (n = 23) or sham procedure (n = 18) in Cycle 1. In Cycle 2, the BoNT-A group received a second episode of BoNT-A (n = 20) and sham group received their first episode of BoNT-A (n = 17). A pediatric rehabilitation specialist masked to group allocation graded each adverse event (AE) according to system, severity (mild, moderate, serious, sentinel) and causality (unlikely/unrelated; possible; probable/definite). RESULTS: There was no difference for all moderate/serious AEs between the BoNT-A and sham/control groups in either Cycle 1 (incident rate ratio = 1.30, 95% confidence interval = 0.43–4.00; P = .64) or Cycle 2 (incident rate ratio = 0.72, 95% confidence interval = 0.30–1.75; P = .47). In Cycle 2, 1 serious, 3 moderate (single-episode group), and 24 mild (single-episode group n = 10; 2 episode group n = 14) AEs were probably/definitely related to BoNT-A. CONCLUSIONS: Children receiving BoNT-A were at no greater risk of moderate/serious AEs compared with a sham control procedure. There was no increased risk of moderate/serious AEs between one and two episodes of BoNT-A.

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