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

January 9, 2009 updated by: Air Liquide Santé International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92118
        • Beaujon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
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
PLACEBO_COMPARATOR: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain measurement by using Visual Analog Scale (VAS)
Time Frame: At the end of the liver biospy
At the end of the liver biospy

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's acceptance and doctor's satisfaction
Time Frame: At the end of the liver biopsy
At the end of the liver biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Liquide Santé International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (ESTIMATE)

March 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EudraCT : 2006-004203-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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