The Post-Operative Pain in Cerebral Palsy (POPPIES) Trial
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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 these children require major (bony) hip surgery. After bony hip surgery the
management of pain is very difficult, as spasticity tends to increase and causes painful
spasms which are difficult to control. Botulinum Toxin injections are known to reduce
spasticity and therefore should also reduce pain. These injections take at least a week to
work, but the effects can last for months. Botulinum Toxin is already an established
treatment for chronic hip pain prior to surgery. The investigators aim to find out whether
Botulinum Toxin injections can reduce post-operative pain. The identification of the level of
pain can be challenging because most of these children are unable to communicate verbally.
The investigators are therefore using a validated pain scoring tool that was designed
especially for such children. This study will be the first to describe fully the pain
experience of children with cerebral palsy undergoing this type of major surgery. The
investigators will compare Botulinum Toxin injections with placebo (non-active) injections.
There is a high emotional and financial burden on the families of these children. Families
describe high levels of emotional distress around the time of surgery, particularly when
their child is in pain. Difficulty with pain control post operatively may delay discharge
from hospital and parental return to work. It causes disrupted sleep for the child and family
and may delay the child's return to school. The results of this study will be shared with
professionals and families at international conferences and in scientific and popular
(patient-based) publications. This study cannot be undertaken in adults with cerebral palsy
as they only rarely undergo this sort of surgery.