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Sponsored by: |
Air Liquide Santé International |
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Information provided by: | Air Liquide Santé International |
ClinicalTrials.gov Identifier: | NCT00643656 |
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.
Condition | Intervention | Phase |
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Liver Biopsy |
Drug: Kalinox 170 bar Drug: Mix of 50% oxygen and 50% nitrogen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion |
Estimated Enrollment: | 94 |
Study Start Date: | October 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Mixture of 50% nitrous oxide and 50% oxygen
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Drug: Kalinox 170 bar
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
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B: Placebo Comparator
Mixture of 50% oxygen and 50% nitrogen
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Drug: Mix of 50% oxygen and 50% nitrogen
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Air Liquide Santé International ( Peter ONODY, MD ) |
Study ID Numbers: | EudraCT : 2006-004203-19 |
Study First Received: | March 19, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00643656 History of Changes |
Health Authority: | France : Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) |
Liver biopsy |
Nitrous Oxide |