Safety of botulinum toxin type a for children with nonambulatory cerebral palsy

Edwards, Priya, Sakzewski, Leanne, Copeland, Lisa, Gascoigne-Pees, Laura, McLennan, Kim, Thorley, Megan, Kentish, Megan, Ware, Robert and Boyd, Roslyn (2015) Safety of botulinum toxin type a for children with nonambulatory cerebral palsy. Pediatrics, 136 5: 895-904. doi:10.1542/peds.2015-0749


Author Edwards, Priya
Sakzewski, Leanne
Copeland, Lisa
Gascoigne-Pees, Laura
McLennan, Kim
Thorley, Megan
Kentish, Megan
Ware, Robert
Boyd, Roslyn
Title Safety of botulinum toxin type a for children with nonambulatory cerebral palsy
Journal name Pediatrics   Check publisher's open access policy
ISSN 0031-4005
1098-4275
Publication date 2015-10-19
Year available 2015
Sub-type Article (original research)
DOI 10.1542/peds.2015-0749
Open Access Status Not Open Access
Volume 136
Issue 5
Start page 895
End page 904
Total pages 10
Place of publication Elk Grove Village, IL, United States
Publisher American Academy of Pediatrics
Language eng
Abstract 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).
Formatted abstract
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.
Keyword Pediatrics
Pediatrics
Q-Index Code C1
Q-Index Status Confirmed Code
Grant ID 10268
1037220
1090828
Institutional Status UQ

 
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Created: Tue, 27 Oct 2015, 20:47:18 EST by Ms Leanne Sakzewski on behalf of School of Health & Rehabilitation Sciences