The Post-Operative Pain in cerebral Palsy (POPPIES) trial

• Research type

  Research Study

• Full title

  Post-operative pain in children with cerebral palsy following major hip surgery: a double blind randomised placebo controlled trial of pre-operative Botulinum toxin type A. [The Post-Operative Pain in cerebral Palsy (POPPIES) trial]

• IRAS ID

  64959

• Contact name

  Fabian Norman-Taylor

• Eudract number

  2010-023240-33

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Intra-muscular botulinum toxin may reduce post-operative pain in children with cerebral palsy following major (bony) hip surgery. Research is required to assess its value in this setting. This cannot be studied in adults as they rarely undergo such surgery. It is a well established, clinically effective and safe drug for muscle spasticity in CP. Research so far suggests it may reduce chronic hip pain, and post-operative pain for children with cerebral palsy undergoing minor muscle surgery. Cerebral palsy (CP) is the commonest cause of physical disability in childhood, and affects up to 3 children per 1000. Over 25% are in the more affected groups - GMFCS levels IV and V. These children are not independently ambulant and are likely to have communication difficulties. They are at high risk of hip displacement (ie the hip gradually comes out of its socket) and it is well-established that hip displacement is painful for some children. Hip displacement requires bony reconstructive surgery. The indications for and the benefits of this surgery are well-established. In a child with spasticity, high post-operative muscle tone may be a cause of painful muscle spasms. These involuntary and sustained muscle contractions are thought to contribute significantly to pain in children with cerebral palsy. There are a number of treatments available for muscle spasm in cerebral palsy, but all are systemic (and therefore they affect the whole body). Botulinum toxin however targets individual muscles by means of intramuscular injection. The Paediatric Pain Profile (PPP) is a validated pain questionnaire which objectively measures pain in children with communication difficulties. We have experience of using this questionnaire to describe pain in this group of children, and we will use it as our primary outcome measure. It is a user friendly system, already in place at our institution.

• REC name

  Wales REC 3

• REC reference

  11/WA/0010

• Date of REC Opinion

  21 Apr 2011

• REC opinion

  Further Information Favourable Opinion