Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion - Full Text View

Sponsored by:	Air Liquide Santé International
Information provided by:	Air Liquide Santé International
ClinicalTrials.gov Identifier:	NCT00643656

Purpose

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
Liver Biopsy	Drug: Kalinox 170 bar Drug: Mix of 50% oxygen and 50% nitrogen	Phase IV

U.S. FDA Resources

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

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:

Pain measurement by using Visual Analog Scale (VAS) [ Time Frame: At the end of the liver biospy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient's acceptance and doctor's satisfaction [ Time Frame: At the end of the liver biopsy ] [ Designated as safety issue: No ]

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
A: Experimental Mixture of 50% nitrous oxide and 50% oxygen	Drug: Kalinox 170 bar Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
B: Placebo Comparator Mixture of 50% oxygen and 50% nitrogen	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patient requiring a liver biopsy of focal lesion
Age upper than 18 years
OMS : 0 to 3
patient consent form signed

Exclusion Criteria:

patient unable to use Visual Analog Scale (VAS)
OMS upper than 3
coagulation disorder
contraindication linked to the experimental product
patient already included in another clinical trial uncompatible with this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643656

Locations

France
Beaujon hospital
Clichy, France, 92118

Sponsors and Collaborators

Air Liquide Santé International

More Information

No publications provided

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)

Keywords provided by Air Liquide Santé International:

Liver biopsy

Study placed in the following topic categories:

Nitrous Oxide

ClinicalTrials.gov processed this record on May 07, 2009