MEOPA to Improve Physical Therapy Results After Multilevel Surgery (KINOPA)
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ClinicalTrials.gov Identifier: NCT00632528 |
Recruitment Status :
Completed
First Posted : March 10, 2008
Last Update Posted : February 3, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cerebral Palsy Spastic Diplegia Quadriplegia Hemiplegia | Drug: MEOPA Drug: Medicinal air | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
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Experimental: 1
Administration of MEOPA gaz during postoperative physical therapy
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Drug: MEOPA
Administration of MEOPA gaz during postoperative physical therapy |
Placebo Comparator: 2
Administration of medical air during postoperative physical therapy
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Drug: Medicinal air
Administration of medical air during postoperative physical therapy |
- Knee range of motion [ Time Frame: at 7 days ]
- Improvement of function after surgery [ Time Frame: at 7 days ]

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Ages Eligible for Study: | 6 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Multilevel surgery
- Spastic cerebral palsy
Exclusion Criteria:
- Patient not being able to walk

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632528
France | |
Robert Debré University Hospital | |
Paris, France, 75019 |
Principal Investigator: | Ana PRESEDO, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00632528 |
Other Study ID Numbers: |
P061007 CRC 06 013 ( Other Identifier: CRC ) |
First Posted: | March 10, 2008 Key Record Dates |
Last Update Posted: | February 3, 2023 |
Last Verified: | February 2008 |
MEOPA spasticity multilevel surgery cerebral palsy children |
Muscle Spasticity Cerebral Palsy Hemiplegia Quadriplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Paralysis |