EUCTR2010-023240-33-GB
Active, not recruiting
Phase 1
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
Guys and St Thomas' NHS Foundation Trust0 sites54 target enrollmentMarch 2, 2011
ConditionsPost Operative Pain in Cerebral PalsyLevel: LLT Classification code 10054710 Term: Post Operative Hip PainLevel: LLT Classification code 10008129 Term: Cerebral Palsy
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post Operative Pain in Cerebral Palsy
- Sponsor
- Guys and St Thomas' NHS Foundation Trust
- Enrollment
- 54
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral OsteotomiesPostoperative PainCerebral PalsyNCT00964639University of Aarhus12
Completed
Phase 3
The Post-Operative Pain in Cerebral Palsy (POPPIES) TrialCerebral PalsyPost-operative PainNCT01437644Guy's and St Thomas' NHS Foundation Trust54
Active, not recruiting
Not Applicable
POST-OPERATIVE PAIN CONTROL OF PEDIATRIC PATIENTS UNDERWENT ORTHOPEDIC SURGERY: COMPARISON OF INTRAVENOUS ANALGESIA AND ONE-SHOT EPIDURAL LUMBAR NERVE BLOCK. - Peri-TraumaPOST-OPERATIVE PAIN CONTROL OF PEDIATRIC PATIENTS UNDERWENT ORTHOPEDIC SURGERYMedDRA version: 9.1Level: SOCClassification code 10028395EUCTR2010-018600-87-ITAZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Recruiting
Not Applicable
A longitudinal study looking at the prevalence, risk factors, and consequences of persistent post-surgical pain in children. (POPSICLE)ACTRN12623000517673Telethon Kids Institute5,000
Not yet recruiting
Not Applicable
Comparision of pain relief after adenotonsilletomy in children with or without topical anaesthesia.Health Condition 1: J353- Hypertrophy of tonsils with hypertrophy of adenoidsCTRI/2020/09/027524AIR FORCE HOSPITA