Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy.
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.
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, priya.edwards@health.qld.gov.au.
Priya
P
Edwards
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Leanne
L
Sakzewski
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Lisa
L
Copeland
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Laura
L
Gascoigne-Pees
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Kim
K
McLennan
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Megan
M
Thorley
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital, Brisbane Australia; Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Megan
M
Kentish
Centre for Children's Health Research, Children's Health Queensland, and School of Population Health, The University of Queensland, Brisbane, Australia.
Robert
R
Ware
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland.
Roslyn N
RN
Boyd
D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D051346:Mobility Limitation; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A