Safety of botulinum toxin type a for children with nonambulatory cerebral palsy
MetadataShow full item record
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.
Showing items related by title, author, creator and subject.
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 ...
Muscle volume alterations in spastic muscles immediately following botulinum toxin Type-A treatment in children with cerebral palsyWilliams, Sian; Reid, S.; Elliott, Catherine; 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 ...
The effect of botulinum toxin-A on the functional ability of young children with spastic hemiplegia due to cerebral palsyLove, Sarah C. (2009)The purpose of this thesis is to determine the impact of very early-start injection of botulinum toxin-A (BoNT-A) on the quality of movement and the functional ability of children with hemiplegic cerebral palsy (CP). ...