Status:
COMPLETED
The Post-Operative Pain in Cerebral Palsy (POPPIES) Trial
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Cerebral Palsy
Post-operative Pain
Eligibility:
All Genders
2-15 years
Phase:
PHASE3
Brief Summary
Cerebral palsy is common. It affects approximately 3 per 1000 children. Hip displacement due to muscle tightness (spasticity) occurs in up to half of the more severely affected children, and many of t...
Detailed Description
Botulinum toxin injected intramuscularly is beneficial in the management of spasticity and as a treatment for chronic hip pain in children with cerebral palsy. Botulinum injections also seem to be use...
Eligibility Criteria
Inclusion
- The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy (appendix 2).
- The child is between the ages of 2 and 15 years (inclusive).
- The child has a GMFCS level of IV or V
- The child has a diagnosis of hypertonic cerebral palsy (or a diagnosis consistent with this nomenclature)
- The child does not communicate verbally
- Informed consent to participate has been given by parent/carer.
Exclusion
- The child is younger than 2 years or older than 15 years
- The child has an acute and current systemic infection or illness
- The child has had botulinum toxin injections within the past 4 months
- The child has had a previous reaction to botulinum toxin
- The child has received or is likely to receive, at the time of trial drug or placebo administration, medications which might interact with botulinum toxin (this does not apply to any drugs at present)
- Insufficient understanding of the trial by the parent or carer, in the investigator's opinion.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01437644
Start Date
October 1 2011
End Date
January 1 2015
Last Update
May 1 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom, SE1 7EH