ABSTRACTS SUBMITTED TO THE FLORIDA BOTULINUM TOXIN CONFERENCE NOV 1999

Authors


  • The following abstracts should have been included in Supplement 2 of Volume 15, 2000. We apologize to the authors for the oversight.

Children with CP Tolerate Repeated BtA Injection Sessions without GA

Abstract:

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.

A Systematic Review of Controlled Trials of the Use of Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity in Cerebral Palsy

Abstract:

In the light of growing acceptance of the use of botulinum toxin type A (BtA) as an adjunct to the treatment of lower limb spasticity in cerebral palsy (CP), we undertook a systematic review of the controlled evidence to support this view.

Following the guidelines of the Cochrane Collaboration, a thorough search was conducted, including contacting researchers or pharmaceutical companies directly, to identify all the published studies into the use of BtA for leg spasticity in CP. Only studies that were randomized and had a control group not receiving BtA were eligible for the review. Three eligible studies were found in which data were adequate for review. Two reviewers independently appraised each study for methodological quality. One study compared BtA with injection of a placebo and two studies compared BtA with the use of casts. No data could be extracted for meta-analysis.

The comparison of BtA and placebo showed promising results but was too small and short term to demonstrate a convincing effect. The two studies comparing BtA and casts found the two treatments to be very similar in their effects.

We will re-evaluate this review as soon as additional trial data becomes available. The review concludes that there is a paucity of controlled evidence to support the use of BtA for leg spasticity in CP and discusses the type of research needed to establish its efficacy.

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