Dettagli per singolo studio

DEC-NET Serial number GB233

Published online	24/05/2004 16.47.00
Last updated	22/11/2005 9.57.30

Other protocol ID number	N0192134868
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
Target N. of subjects	20
Major Disease (ICD9 class)	CEREBRAL PALSY NOS
Experimental drug
Botulinum A (Dysport) Treatment regimen (dosage and duration) N/A
Control drug
Botulinum A (Dysport) Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	4-12 years
Eligibility criteria
Inclusion criteria
Boys and girls with cerebral palsy (hemiplegia and diplegia)
Exclusion criteria
Refusal to consent
Trial design/methodology
Phase	4
Kind of study	Efficacy Safety
Design	Controlled Randomised Single blind
Purpose of study
How can injection technique be improved to increase efficacy per dose of botulinum toxin, as measured by observational gait analysis? This study will examine whether multiple injection technique treatment is more effective than single injection technique, for spastic muscle in children with cerebral palsy. We shall examine the effect of dividing the standard treatment of single injections of Botulinum to the Gastrocnemius muscle into multiple smaller injections. We shall also compare discomfort at time of injection, by standardised child and parent reporting scales. Null hypothesis -there is no difference in efficacy or adverse effects between single versus multiple injections.
Primary outcomes
Efficacy of Botulinum toxin injection to that muscle, as assessed by observational gait scale, before the study at 4 weeks and then at 12 weeks.
Secondary outcomes
The discomfort at the time of injection
Summary of study design, objectives, and ongoing research findings
A Single blinded cross over trial How can injection technique be improved to increase efficacy per dose of botulinum toxin, as measured by observational gait analysis. This study will examine whether multiple injection technique treatment is more effective than single injection technique, for spastic muscle in children with cerebral palsy. We shall examine the effect of dividing the standard treatment of single injections of Botulinum to the Gastrocnemius muscle into multiple smaller injections. We shall also compare discomfort at time of injection, by standardised child and parent reporting scales. Null hypothesis -there is no difference in efficacy or adverse effects between single versus multiple injections. Children are recruited to the study and consent is signed by themselves and/or their carers. They are randomised to group A or group B. Group A. Proceed first to single injections to the gastrocnemius 2 cm each side of the mid-line, one fifth of the distance from the tibial condyles to the ankle malleoli. A total dose of Botulinum A [Dysport] of 12 Units/kg, to a maximum 500 Units, is given in two divided fractions, using a concentration of Botulinum A [Dysport] 500 Units in 5ml N saline. Six months later they receive the same total dose of Botulinum A at the same concentration but divided into 10 fractions. Five injections are given 2 cm on either side of the midline of the muscle and evenly spaced, starting one fifth of the distance from the tibial condyles to the ankle malleoli and ending just past the major bulge of the gastrocnemius muscle. Group B. First receive the multiple injections, then six months later single injections using the same techniques as for Group A. For each injection, the injected area of skin is treated with local anaesthetic gel [Amethocaine], 1 hour beforehand. Thirty minutes before injection, they are given oral midazolam 0.7mg/kg as relaxant, and oral diclofenac 1 mg/kg as analgesic.