54
Participants
Start Date
October 31, 2011
Primary Completion Date
September 30, 2014
Study Completion Date
January 31, 2015
botulinum toxin intramuscular injection
"A single dose of active drug or placebo will be administered immediately prior to surgery.~The injections will be given to the anaesthetised child before the surgical procedure begins. The surgeon will perform the injections at three muscle groups around each hip: the adductors, hamstrings and iliopsoas muscles. Two units per kilogram will be given at each site. The maximum dose will be 12 units per kilogram or 500 units in total (whichever is the lesser), divided equally between six or three sites. Each active drug vial will contain 100 iu of the Botox preparation. The volume injected will be dependent on the weight of the child. Injections of normal saline will be administered in those children randomised to the placebo."
Guy's and St Thomas' NHS Foundation Trust, London
Guy's and St Thomas' NHS Foundation Trust
OTHER