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NCT00632528: KINOPA
Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.
Phase 3 trial testing MEOPA in Cerebral Palsy in 64 participants. Completed in 1 March 2011.
1 March 2011
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 March 2008 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 March 2011 |
| Sites | 1 location across France |
Drugs / interventions tested
- MEOPA — full drug profile →
- Medicinal air — full drug profile →
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
- Spastic Diplegia — all drugs for Spastic Diplegia →
- Quadriplegia — all drugs for Quadriplegia →
- Hemiplegia — all drugs for Hemiplegia →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 6 to 20, any sex, with Cerebral Palsy or Spastic Diplegia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Knee range of motion
Time frame: at 7 days
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00632528
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MEOPA
Trials testing the same drug.
- NCT07118644 — Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples · Phase 3 · not yet recruiting
- NCT03638921 — 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain i · Phase 2 · completed
Other recruiting trials for Cerebral Palsy
Currently open trials in the same condition.
- NCT07524972 — Antenatal Magnesium Sulphate in High-Risk Preterm Patients · Phase 3 · recruiting
- NCT07432789 — Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performa · NA · recruiting
- NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
- NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
- NCT07342348 — Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy · NA · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00632528 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 2 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00632528.
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