Safety of botulinum toxin A in children and adolescents with cerebral palsy in a pragmatic setting.

This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal adverse events were reported (3.3% of the total injections number, 8.7% of the patients). On five occasions, the adverse reactions observed in GMFCS V children were attributed to the sedation used (rectal midazolam plus pethidine; buccal midazolam) and resulted in prolongation of hospitalization. Of the reactions attributed to the toxin, 23 involved an excessive reduction of the muscle tone either of the injected limb(s) or generalized; others included local pain, restlessness, lethargy with pallor, disturbance in swallowing and speech production, seizures, strabismus, excessive sweating, constipation, vomiting, a flu-like syndrome and emerging hypertonus in adjacent muscles. Their incidence was associated with GMFCS level and with the presence of epilepsy (Odds ratio (OR) = 2.74 - p = 0.016 and OR = 2.35 - p = 0.046, respectively) but not with BoNT-A dose (either total or per kilogram). In conclusion, treatment with BoNT-A was safe; adverse reactions were mostly mild even for severely affected patients. Their appearance did not necessitate major changes in our practice.

Botulinum toxin treatment in upper limb spasticity: treatment consistency.

This study assessed treatment consistency of botulinum toxin administration in spastic upper limbs under pragmatic conditions, as derived through stability of dosages and between injections intervals. Over a period of 8 years, 153 children (81 with bilateral spastic cerebral palsy, 72 with unilateral) were treated according to accepted, experience-based guidelines with Botox and Dysport. Treatment response was based on assessment of spasticity and attainment of pre-determined goals at 3, 6 and 12 months post each treatment. Mean age at treatment onset was 6y 4mo (SD: 4y 10mo), median F/U, 2.5 years (4 months-6 8/12 years). Number of injection sessions was 1-10; few had more than 6 sessions. In 106 (69.28%) children, more than one anatomic regions of the limb were injected. Most (56.2%), had at least two injection sessions; median time interval between the sessions was 9 months (IQR: 4-35 months, similar for unilateral and bilateral cerebral palsy, p = 0.874). Children >4 years old at the first treatment had longer intervals between sessions (25.8%) compared to younger ones (p = 0.010). The mixed effects models demonstrated that botulinum toxin dosage was stable over subsequent visits (p = 0.144) and that intermediate intervals for subsequent visits were similar to the first one (p = 0.279).