No abstract

There was no evidence of cumulative or persisting benefit from repeated botulinum toxin A (BtA) at the injection cycle troughs at 1 year or 2 years. The dose was not enough to change spasticity measures and thus GMFM in this heterogeneous group. Ceiling effects in GMFM and Pediatric Evaluation of Disability Index (PEDI) may have reduced responsiveness. This finding does not deny the value, individually, of single injection cycles or prove that repeating them is unhelpful. In this regard, BtA treatment can be viewed in the same light as other temporary measures to relieve spasticity, such as oral or intrathecal agents: there is no evidence of continuing benefit if the treatment ceases. The study provides long-term, fully controlled adverse event data and has not revealed any long-term adverse effects.

Although controlled data on botulinum toxin type A (BtA) in cerebral palsy (CP) mainly relates to single injection sessions, children with CP on this treatment are likely to receive multiple injections in separate sessions over a number of years. Early researchers used general anaesthetic (GA) to make sessions more acceptable and to ensure accurate placement of injections. Accumulating experience has allowed an increasing proportion of sessions without GA.We are monitoring the acceptability of injections given three times monthly to children with CP and spasticity taking part in a double blind, parallel group, randomized controlled trial of repeated BtA/placebo injections over 2 years. The children have (1) sedation with oral midazolam 0.5-0.75 mg/kg alone;(2) local anaesthetic cream (EMLA or Ametop) alone; (3) both; or (4) neither. The choice is made at each visit after discussion between parents, researchers, and sometimes, the children. Within 5-10 minutes of BtA/placebo injection, parents are asked to rate the distress caused to their child by the procedure as none, minor, moderate, or major.After 240 injection sessions in 59 children the responses have been as follows: 21.3% (51) no distress; 57.9% (139) minor distress; 17.9% (43) moderate distress; 2.9% (7) major distress. These results will be discussed in further detail.In conclusion, it seems acceptable to most children and caregivers for BtA injections to be given without GA, even when repeated sessions are required.