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

Phase 1

• Conditions: Post Operative Pain in Cerebral Palsy; Level: LLT Classification code 10054710 Term: Post Operative Hip Pain; Level: LLT Classification code 10008129 Term: Cerebral Palsy

• Registration Number: EUCTR2010-023240-33-GB
• Lead Sponsor: Guys and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-02
• Study Completion: 2015-01-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

1.The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy.
2.The child is between the ages of 2 and 18 years.
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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.The child is younger than 2 years or older than 18 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary outcome measures: length of stay, return to school, tolerance of sitting,transfusion requirements and quality of life. We will collect information on pain throughout the course of the study which will generate a comprehensive description of the patient's pain experience. ;Primary end point(s): Change in pain score during the six weeks following the operation;<br> Main Objective: To assess the benefit to children with cerebral palsy of having botulinum toxin injections prior to major hip surgery, in order to reduce their post-operative pain.<br><br> To describe the pain experience of children with cerebral palsy undergoing major hip surgery.<br>