Cerebral PalsyPhase 3KINOPANCT00632528
MEOPA to Improve Physical Therapy Results After Multilevel Surgery
A Phase 3 study testing MEOPA and Medicinal air in people with Cerebral Palsy and Spastic Diplegia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia, Quadriplegia
- What is being tested?
- MEOPA and Medicinal air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Multilevel surgery
- Spastic cerebral palsy
Who cannot join
- Patient not being able to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.
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.
Read the detailed description
The study is a randomized, single blinded, controlled clinical trial. It consist of two groups of patients: one group will receive MEOPA (FDA approval-"AMM" in France, 2003) and the other will receive medical air.
Results, in terms of articular range of motion, will be compared between groups after five sessions of REHAB. The following items will be evaluated: degree of pain, measured by a pain scale; joint ROM; number of sessions to obtain the desired results; parents, patients and caregivers satisfaction.
Patients aging from 6 to 20 years will be included if they meet selection criteria. Inclusions are confirmed before the first session starts. At this time, informed consent is to be signed by patients or parents and the Clinical Epidemiology Unit will assign a study number to the patient.
All patients get morphine therapy before the REHAB session; a new dose is administrated 10 minutes later if pain is higher than 4/10; ten minutes later, if pain is still over 4/10, MEOPA (or medical air) will be administrated. If this is not enough to diminish pain, the session will be interrupted. Five physical therapy sessions are provided after surgery, during inpatient time.
Knee ROM will be measured by goniometry and will be the measure of reference to evaluate the influence of MEOPA. Two types of pain scale will be used: analogical scale from 1 to 10 and faces scale (FPS-R) for small children.
For security reasons, the person who administrates de gaz will be informed of the nature of the product (MEOPA or medical air), the bottle will be masked and the therapist won't know what kind of product is being administrated.
- Conditions
- Cerebral Palsy, Spastic Diplegia, Quadriplegia, Hemiplegia
- Being tested
- MEOPA, Medicinal air
- Keywords
- MEOPA, spasticity, multilevel surgery, cerebral palsy, children
- Medical subject headings
- Cerebral Palsy, Quadriplegia, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
Administration of MEOPA gaz during postoperative physical therapy
Medicinal airDrug
Administration of medical air during postoperative physical therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of MEOPA gaz during postoperative physical therapy Receives: Drug: MEOPA |
| 2 | Placebo comparator | Administration of medical air during postoperative physical therapy Receives: Drug: Medicinal air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee range of motion
Measured: at 7 days
Secondary outcomes (1)
Improvement of function after surgery
Measured: at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana PRESEDO, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632528
- Sponsor's protocol ID
- P061007
- Other IDs
- CRC 06 013
- Acronym
- KINOPA
- Status last verified
- Feb 2008
- First submitted
- 28 Feb 2008
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28726270
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.
- ClinicalTrials.gov ID
- NCT00632528
- Acronym / sponsor ID
- KINOPA / P061007
- Conditions
- Cerebral Palsy, Spastic Diplegia, Quadriplegia, Hemiplegia
- Keywords
- MEOPA, spasticity, multilevel surgery, cerebral palsy, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomized, single blinded, controlled clinical trial. It consist of two groups of patients: one group will receive MEOPA (FDA approval-"AMM" in France, 2003) and the other will receive medical air.
Results, in terms of articular range of motion, will be compared between groups after five sessions of REHAB. The following items will be evaluated: degree of pain, measured by a pain scale; joint ROM; number of sessions to obtain the desired results; parents, patients and caregivers satisfaction.
Patients aging from 6 to 20 years will be included if they meet selection criteria. Inclusions are confirmed before the first session starts. At this time, informed consent is to be signed by patients or parents and the Clinical Epidemiology Unit will assign a study number to the patient.
All patients get morphine therapy before the REHAB session; a new dose is administrated 10 minutes later if pain is higher than 4/10; ten minutes later, if pain is still over 4/10, MEOPA (or medical air) will be administrated. If this is not enough to diminish pain, the session will be interrupted. Five physical therapy sessions are provided after surgery, during inpatient time.
Knee ROM will be measured by goniometry and will be the measure of reference to evaluate the influence of MEOPA. Two types of pain scale will be used: analogical scale from 1 to 10 and faces scale (FPS-R) for small children.
For security reasons, the person who administrates de gaz will be informed of the nature of the product (MEOPA or medical air), the bottle will be masked and the therapist won't know what kind of product is being administrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEOPAAdministration of MEOPA gaz during postoperative physical therapy |
| 2 | Placebo comparator | Drug: Medicinal airAdministration of medical air during postoperative physical therapy |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Multilevel surgery
- Spastic cerebral palsy
Key exclusion criteria (1 listed)
- Patient not being able to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEOPAAdministration of MEOPA gaz during postoperative physical therapy | Drug | 1 |
| Medicinal airAdministration of medical air during postoperative physical therapy | Drug | 2 |
Primary outcome
Knee range of motion
Time frame: at 7 days
1 secondary outcome
Improvement of function after surgery
Time frame: at 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Results publication: PubMed 28726270Delafontaine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana PRESEDO, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MEOPA and Medicinal air in people with Cerebral Palsy and Spastic Diplegia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee range of motion (time frame: at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.