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

AIM: To identify factors that increase the likelihood of systemic adverse events after botulinum neurotoxin A (BoNT-A) injections in children with cerebral palsy (CP). METHOD: A prospective observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Occurrences of systemic adverse events, defined as lower respiratory tract illnesses, generalized weakness, dysphagia, and death were determined at follow-up. The relationship between systemic adverse events and eight preinjection variables (age, Gross Motor Function Classification System [GMFCS] level, history of dysphagia, gastrostomy, aspiration pneumonia, recent history of illness, BoNT-A dose, and type of sedation) were examined using univariable and multivariable logistic regression with generalized estimating equations methods. RESULTS: In total 591 children underwent 2219 injection episodes with follow-up in 2158 (97%) cases. Systemic adverse events were reported in 77 (3.6%) injection episodes. Univariable analysis suggested that GMFCS levels IV and V, a history of dysphagia, gastrostomy, aspiration pneumonia, and increasing BoNT-A dose increase the likelihood of systemic adverse events. In multivariable analysis, a history of dysphagia (odds ratio [OR] 3.42) and/or aspiration pneumonia (OR 2.31) remained associated with increased likelihood of systemic adverse events. INTERPRETATION: A history of dysphagia and/or aspiration pneumonia are the factors that most increase the likelihood of systemic adverse events after BoNT-A. WHAT THIS PAPER ADDS: Systemic adverse events occur in 3.6% of botulinum neurotoxin A (BoNT-A) injection episodes. Dysphagia and/or aspiration pneumonia are associated with increased likelihood of systemic adverse events. Multivariable models showed no evidence of association between Gross Motor Function Classification System and systemic adverse events. Multivariable models showed no evidence of association between BoNT-A dose and systemic adverse events.

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

AIM: To determine the incidence of common adverse events after botulinum toxin A (BoNT-A) injections in children with cerebral palsy (CP) and to identify whether the severity of CP influences the incidence of adverse events. METHOD: This was an observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Data examined included procedural adverse events at the time of injection and at follow-up. Systemic adverse events were defined as lower respiratory tract illnesses, generalized weakness, dysphagia, and death. Severity of CP was categorized by the Gross Motor Function Classification System (GMFCS). The relationships between GMFCS and adverse events were analysed using negative binomial regression models. RESULTS: In total, 591 children underwent 2219 injection episodes. Adverse events were reported during the procedure (130 [6%] injection episodes) and at follow-up (492 [22%] injection episodes). There were significantly increased rates of systemic adverse events in injection episodes involving children in GMFCS level IV (incidence rate ratio [IRR] 3.92 [95% confidence interval] 1.45-10.57]) and GMFCS level V (IRR 7.37 [95% confidence interval 2.90-18.73]; p<0.001). INTERPRETATION: Adverse events after BoNT-A injections are common but mostly mild and self-limiting. Children in GMFCS levels IV and V are at increased risk of systemic adverse events. The relationship between CP severity and BoNT-A adverse events is complex and further research is required to better understand this relationship. WHAT THIS PAPER ADDS: Adverse events reported at the time of botulinum toxin A injection occurred in 6% of injection episodes. Adverse events were reported at follow-up in 22% of injection episodes. Children in Gross Motor Function Classification System (GMFCS) levels IV and V have increased rates of systemic adverse events. Children in GMFCS levels IV and V report less local weakness and pain.

Normative reference values for lower limb joint range, bone torsion, and alignment in children aged 4-16 years.

Normative reference values are essential to identify deviation from normal and evaluate response to treatment. As joint range of motion datasets specific to the pediatric population are infrequently reported in the literature, we determined lower limb passive joint range of motion and bone torsion values from 53 typically developing children aged 4-16 years. Our reference values were consistent with previously published norms, although for some measures, large variability in the literature exists. A clear correlation between joint range and age was observed in most measures. Our results highlight the importance of applying age-matched norms when attempting to identify deviation from normal in the growing child.

Orthopedic surgery and mobility goals for children with cerebral palsy GMFCS level IV: what are we setting out to achieve?

BACKGROUND: Multilevel orthopedic surgery is considered to be the gold standard treatment for ambulatory children with cerebral palsy (CP), classified at levels I, II, or III according to the Gross Motor Function Classification System (GMFCS). Hip enlocation and stability are the main goals of orthopedic intervention in the GMFCS level IV subgroup and are well researched; however, there is no evidence to date to support or challenge the effectiveness of orthopedic treatment to preserve functional mobility in this patient group. The aim of this study was to evaluate the results of orthopedic surgery to maintain or restore standing transfers and supported walking in children with CP at GMFCS level IV. METHODS: Twenty-two children with CP GMFCS level IV who underwent orthopedic surgery to improve mobility between the years 2004 and 2008 were included in this study. A retrospective chart review was performed and a satisfaction questionnaire sent to all patients. The primary outcome measure was the attainment and maintenance of mobility goals 2 years post-surgery. The secondary outcome measures were family/patient satisfaction, Functional Mobility Scale (FMS), and complications. RESULTS: The two goals identified by the patients and carers were standing transfers and supported walking. At the 2-year post-surgery assessment, 14 children (63.6 %) did not reach their pre-determined goals. In the questionnaire, 21.4 % of the families reported that surgery was not beneficial. The FMS score remained unchanged in 95.4 % of the patients. Fourteen patients (63.6 %) had at least one complication that prolonged their post-operative rehabilitation (e.g., neuropraxia). CONCLUSION: This study suggests that orthopedic surgery in children with CP at GMFCS level IV is unlikely to maintain or restore mobility. Furthermore, it carries a significant risk of complications. LEVEL OF EVIDENCE: Case series, Level IV.