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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

1. The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy (appendix 2).

2. The child is between the ages of 2 and 15 years (inclusive).

3. The child has a GMFCS level of IV or V

4. The child has a diagnosis of hypertonic cerebral palsy (or a diagnosis consistent with this nomenclature)

5. The child does not communicate verbally

6. Informed consent to participate has been given by parent/carer.

Exclusion Criteria:

1. The child is younger than 2 years or older than 15 years

2. The child has an acute and current systemic infection or illness

3. The child has had botulinum toxin injections within the past 4 months

4. The child has had a previous reaction to botulinum toxin

5. 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)

6. Insufficient understanding of the trial by the parent or carer, in the investigator's opinion.