The Post-Operative Pain in Cerebral Palsy (POPPIES) Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

January 31, 2015

Conditions
Cerebral PalsyPost-operative Pain
Interventions
DRUG

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."

Trial Locations (1)

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust, London

All Listed Sponsors
lead

Guy's and St Thomas' NHS Foundation Trust

OTHER

NCT01437644 - The Post-Operative Pain in Cerebral Palsy (POPPIES) Trial | Biotech Hunter | Biotech Hunter