Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy.
In: Pediatrics, Jg. 136 (2015-11-01), Heft 5, S. 895-904
academicJournal
Zugriff:
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. [ABSTRACT FROM AUTHOR]
Titel: |
Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy.
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Autor/in / Beteiligte Person: | Edwards, Priya ; Sakzewski, Leanne ; Copeland, Lisa ; Gascoigne-Pees, Laura ; McLennan, Kim ; Thorley, Megan ; Kentish, Megan ; Ware, Robert ; Boyd, Roslyn N. |
Zeitschrift: | Pediatrics, Jg. 136 (2015-11-01), Heft 5, S. 895-904 |
Veröffentlichung: | 2015 |
Medientyp: | academicJournal |
ISSN: | 0031-4005 (print) |
DOI: | 10.1542/peds.2015-0749 |
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