MEOPA to Improve Physical Therapy Results After Multilevel Surgery
Condition: Cerebral Palsy; Spastic Diplegia; Quadriplegia; Hemiplegia
MeSH terms: Muscle Spasticity; Cerebral Palsy; Hemiplegia; Quadriplegia
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): MEOPA; Medicinal air
Intervention type(s): Drug; Drug
Intervention description(s): Administration of MEOPA gaz during postoperative physical therapy; Administration of medical air during postoperative physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MEOPA; spasticity; multilevel surgery; cerebral palsy; children