Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion

Liver Biopsy Clinical Trial

Official title:

Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643656
• Other study ID #: EudraCT : 2006-004203-19
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2008
• Last updated: January 9, 2009
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Biopsy

Intervention

Drug:
• Kalinox 170 bar
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
• 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

Locations

Country	Name	City	State
France	Beaujon hospital	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement by using Visual Analog Scale (VAS)		At the end of the liver biospy	No
Secondary	Patient's acceptance and doctor's satisfaction		At the end of the liver biopsy	No