MEOPA to Improve Physical Therapy Results After Multilevel Surgery
KINOPA
Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.
2 other identifiers
interventional
64
1 country
1
Brief Summary
Children with cerebral palsy commonly undergo "multilevel surgery", meaning several lower limb combined procedures performed during the same surgical intervention. The aim of this type of surgery is to correct all deformities together in order to restore near to normal anatomy and muscular function. It is very important to be able to obtain good range of motion after surgery, in order to consolidate surgical results. During the first days after the operation, children are sore and it may be difficult to realize adequate physical therapy. In order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have been obtained so far but no study is available to demonstrate these results. The goal of our research is to prove that there is a benefit in using MEOPA postoperatively in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 3, 2023
February 1, 2008
3 years
February 28, 2008
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee range of motion
at 7 days
Secondary Outcomes (1)
Improvement of function after surgery
at 7 days
Study Arms (2)
1
EXPERIMENTALAdministration of MEOPA gaz during postoperative physical therapy
2
PLACEBO COMPARATORAdministration of medical air during postoperative physical therapy
Interventions
Eligibility Criteria
You may qualify if:
- Multilevel surgery
- Spastic cerebral palsy
You may not qualify if:
- Patient not being able to walk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debré University Hospital
Paris, 75019, France
Related Publications (1)
Delafontaine A, Presedo A, Mohamed D, Lopes D, Wood C, Alberti C. Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study. Eur J Pain. 2017 Nov;21(10):1657-1667. doi: 10.1002/ejp.1071. Epub 2017 Jul 20.
PMID: 28726270RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana PRESEDO, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 10, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 3, 2023
Record last verified: 2008-02