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

NCT01437644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-05-01

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Post-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.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Rebecca Newton · King's Health Partners Clinical Trials Office

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-09-30
Completion
2015-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437644 on ClinicalTrials.gov