Safety of botulinum toxin type a for children with nonambulatory cerebral palsy
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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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Botulinum toxin a for nonambulatory children with cerebral palsy: A double blind randomized controlled trialCopeland, L.; Edwards, P.; Thorley, M.; Donaghey, S.; Gascoigne-Pees, L.; Kentish, M.; Lindsley, J.; McLennan, K.; Sakzewski, L.; Boyd, Roslyn (2014)Objectives: To examine the efficacy and safety of intramuscular botulinum toxin A (BoNT-A) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy (CP). Study design: Nonambulant ...
Evaluation of the effects of botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: A double blind randomized controlled trialThorley, M.; Donaghey, S.; Edwards, P.; Copeland, L.; Kentish, M.; McLennan, K.; Lindsley, J.; Gascoigne-Pees, L.; Sakzewski, L.; Boyd, Roslyn (2012)Background: Children with cerebral palsy (CP) whom are non-ambulant are at risk of reduced quality of life and poor health status. Severe spasticity leads to discomfort and pain. Carer burden for families is significant. ...
Muscle volume alterations in spastic muscles immediately following botulinum toxin Type-A treatment in children with cerebral palsyWilliams, Sian; Reid, S.; Elliott, C.; Shipman, P.; Valentine, J. (2013)AIM: With evidence for an atrophic effect of botulinum toxin type A (BoNT-A) documented in typically developing muscles, this study investigated the immediate morphological alterations of muscles in children with cerebral ...