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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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spastic Diplegia Quadriplegia Hemiplegia Drug: MEOPA Drug: Medicinal air Phase 3

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.

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Administration of MEOPA gaz during postoperative physical therapy
Administration of MEOPA gaz during postoperative physical therapy

Placebo Comparator: 2
Administration of medical air during postoperative physical therapy
Drug: Medicinal air
Administration of medical air during postoperative physical therapy

Primary Outcome Measures :
  1. Knee range of motion [ Time Frame: at 7 days ]

Secondary Outcome Measures :
  1. Improvement of function after surgery [ Time Frame: at 7 days ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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Robert Debré University Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Ana PRESEDO, MD Assistance Publique - Hôpitaux de Paris
Publications of Results:
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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
Keywords provided by Assistance Publique - Hôpitaux de Paris:
multilevel surgery
cerebral palsy
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations