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dc.contributor.authorEdwards, Priya
dc.contributor.authorSakzewski, Leanne
dc.contributor.authorCopeland, Lisa
dc.contributor.authorGascoigne-Pees, Laura
dc.contributor.authorMcLennan, Kim
dc.contributor.authorThorley, Megan
dc.contributor.authorKentish, Megan
dc.contributor.authorWare, Robert
dc.contributor.authorBoyd, Roslyn N
dc.date.accessioned2017-11-15T05:46:16Z
dc.date.available2017-11-15T05:46:16Z
dc.date.issued2015
dc.identifier.issn0031-4005
dc.identifier.doi10.1542/peds.2015-0749
dc.identifier.urihttp://hdl.handle.net/10072/172284
dc.description.abstractOBJECTIVE: 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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherAmerican Academy of Pediatrics
dc.relation.ispartofpagefrom895
dc.relation.ispartofpageto904
dc.relation.ispartofissue5
dc.relation.ispartofjournalPediatrics
dc.relation.ispartofvolume136
dc.subject.fieldofresearchPaediatrics and Reproductive Medicine not elsewhere classified
dc.subject.fieldofresearchMedical and Health Sciences
dc.subject.fieldofresearchPsychology and Cognitive Sciences
dc.subject.fieldofresearchcode111499
dc.subject.fieldofresearchcode11
dc.subject.fieldofresearchcode17
dc.titleSafety of botulinum toxin type a for children with nonambulatory cerebral palsy
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.hasfulltextNo Full Text
gro.griffith.authorWare, Robert
gro.griffith.authorKentish, Megan J.


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