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 proced...
| Main Authors: | , , , , , , , , |
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| Format: | Journal Article |
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American Academy of Pediatrics
2015
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| Online Access: | http://hdl.handle.net/20.500.11937/15178 |
| _version_ | 1848748823231332352 |
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| author | Edwards, P. Sakzewski, L. Copeland, L. Gascoigne-Pees, L. McLennan, K. Thorley, M. Kentish, M. Ware, R. Boyd, Roslyn |
| author_facet | Edwards, P. Sakzewski, L. Copeland, L. Gascoigne-Pees, L. McLennan, K. Thorley, M. Kentish, M. Ware, R. Boyd, Roslyn |
| author_sort | Edwards, P. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T07:11:10Z |
| format | Journal Article |
| id | curtin-20.500.11937-15178 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T07:11:10Z |
| publishDate | 2015 |
| publisher | American Academy of Pediatrics |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-151782017-09-13T15:04:45Z Safety of botulinum toxin type a for children with nonambulatory cerebral palsy Edwards, P. Sakzewski, L. Copeland, L. Gascoigne-Pees, L. McLennan, K. Thorley, M. Kentish, M. Ware, R. Boyd, Roslyn 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. 2015 Journal Article http://hdl.handle.net/20.500.11937/15178 10.1542/peds.2015-0749 American Academy of Pediatrics unknown |
| spellingShingle | Edwards, P. Sakzewski, L. Copeland, L. Gascoigne-Pees, L. McLennan, K. Thorley, M. Kentish, M. Ware, R. Boyd, Roslyn Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title | Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title_full | Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title_fullStr | Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title_full_unstemmed | Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title_short | Safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| title_sort | safety of botulinum toxin type a for children with nonambulatory cerebral palsy |
| url | http://hdl.handle.net/20.500.11937/15178 |