Botulinum Toxin A for Nonambulatory Children with Cerebral Palsy: A Double Blind Randomized Controlled Trial

Copeland, Lisa; Edwards, Priya; Thorley, Megan; Donaghey, Samantha; Gascoigne-Pees, Laura; Kentish, Megan; Cert, Grad; Lindsley, Jayne; McLennan, Kim; Sakzewski, Leanne; Boyd, Roslyn N.

doi:10.1016/j.jpeds.2014.01.050

Cited by 60 publications

(82 citation statements)

References 22 publications

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“…10,11 Our recent randomized, double-blinded sham/ controlled trial supported efficacy of intramuscular injections of BoNT-A for nonambulatory children with CP (GMFCS IV and V) to improve comfort and reduce carer burden. 5 Children who received BoNT-A compared with the sham procedure had significantly and clinically greater gains in performance of and satisfaction with care and comfort goals (Canadian Occupational Performance Measure; mean difference of 2.2, 95% confidence interval [CI] 0.8-3.5; P = .02). Children receiving BoNT-A had significantly less pain compared with baseline and improved reported quality of life.…”

Section: What This Study Addsmentioning

confidence: 98%

“…3 In a double-blind randomized controlled trial (RCT), BoNT-A has been shown to reduce pain 4 and improve care and comfort goals for nonambulatory children with CP. 5 In 2008, the safety of BoNT-A for children with CP was called into question by the US Consumer Advocacy Group Public Citizen, which petitioned the US Federal Drug Administration to increase label warnings for commercially available BoNT-A products. 6 At this time, 9 deaths had been reported in children with CP under 16 years of age after intramuscular injections of BoNT-A.…”

Section: What This Study Addsmentioning

confidence: 99%

“…Children receiving BoNT-A had significantly less pain compared with baseline and improved reported quality of life. 5 This study now investigates whether intramuscular injections of BoNT-A increased the risk of AEs for children with CP classified as GMFCS IV or V compared with a sham/control group and whether there was an increase in AEs with repeated BoNT-A injections.…”

Section: What This Study Addsmentioning

confidence: 99%

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Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy

et al. 2015

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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.

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Section: What This Study Addsmentioning

confidence: 98%

Section: What This Study Addsmentioning

confidence: 99%

Section: What This Study Addsmentioning

confidence: 99%

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Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy

et al. 2015

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“…In a systematic review by Pin et al (24), most studies on the use of botulinum toxin A in children with severe CP (GMFCS levels of IV–V) were of poor methodological quality and the evidence of beneficial effects was limited. However, botulinum toxin A was found to be beneficial in terms of the ease of care and comfort of non‑ambulatory children (25). Our study evaluated only gross motor function and not pain, comfort, or ease of care.…”

Section: Discussionmentioning

confidence: 99%

Factors Influencing the Gross Motor Outcome of Intensive Therapy in Children with Cerebral Palsy and Developmental Delay

Hong

Kim

et al. 2017

J Korean Med Sci

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The study was designed to identify factors influencing the short term effect of intensive therapy on gross motor function in children with cerebral palsy or developmental delay. Retrospectively, total Gross Motor Function Measure-88 (GMFM-88) scores measured during the first and last weeks of intensive therapy were analyzed (n = 103). Good and poor responder groups were defined as those in the top and bottom 25% in terms of score difference, respectively. The GMFM-88 score increased to 4.67 ± 3.93 after 8 weeks of intensive therapy (P < 0.001). Gross Motor Function Classification System (GMFCS) level (I–II vs. IV–V; odds ratio [OR] = 7.763, 95% confidence interval [CI] = 2.177–27.682, P = 0.002) was a significant factor in a good response to therapy. Age (≥ 36 months; OR = 2.737, 95% CI = 1.003–7.471, P = 0.049) and GMFCS level (I–II vs. IV–V; OR = 0.189, 95% CI = 0.057–0.630, P = 0.007; and III vs. IV–V; OR = 0.095, 95% CI = 0.011–0.785, P = 0.029) were significantly associated with a poor response. GMFCS level is the most important prognostic factor for the effect of intensive therapy on gross motor function. In addition, age ≥ 36 months, is associated with a poor outcome.

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“…5 The Gross Motor Function Classification System (GMFCS) enables classification of children with CP based on their gross motor function ability. [11][12][13][14] Adverse events after BoNT-A administration have been reported with an incidence of 3% to 23% of injection episodes, with the majority being transient and mild. 4,[7][8][9][10] Additionally, the treatment has been shown to be effective in non-ambulant children (GMFCS levels IV and V) for decreasing pain; ease of positioning and dressing; and improving hygiene.…”

mentioning

confidence: 99%