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

Abstract

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.

Severity of cerebral palsy and likelihood of adverse events after botulinum toxin A injections

“…24 A recent randomized controlled trial reported similar rates of moderate-to-severe adverse events in both BoNT-A treatment and placebo arms. 25 What we have described in this study is a temporal association between BoNT-A injections and adverse events. For some adverse events (perhaps many) this relationship may also be causative; for others, they may be related to the comorbidities and poor health associated with severe CP and unrelated to BoNT-A injections.…”

Systemic adverse events after botulinum neurotoxin A injections in children with cerebral palsy

“…17 Increasing dose (units/kg) has also been suggested to be associated with increased emergency department presentations. 17 Gastrostomy has also been suggested to be associated with more severe adverse events in a study of children in GMFCS levels IV and V. 12 We acknowledge the considerable overlap between those children with dysphagia and those with a gastrostomy.…”

“…Several studies have been published that support decisionmaking in this area. Total adverse events after BoNT-A have been reported to occur in 3.3% to 56% of injection episodes, [11][12][13][14][15] reflecting different study designs. Adverse events with symptoms suggesting systemic spread are less common, 16 estimated to occur in 1% to 2.2% of injection episodes.…”

Tone Reduction and Physical Therapy: Strengthening Partners in Treatment of Children with Spastic Cerebral Palsy

“…Commonly reported side and adverse effects are fatigue, flu-like symptoms, swallowing difficulties, increased seizures and bladder and bowel incontinence. [45][46][47][48][49][50][51][52] These are usually transient. No increased risk is reported between one and two episodes of BoNT.…”