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Completed

NCT Number: NCT00643656

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

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Key information

Conditions

Liver Biopsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beaujon hospital

Clichy, 92118, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kalinox 170 bar

Drug

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

Drug

Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour

Primary outcomes

  1. Pain measurement by using Visual Analog Scale (VAS)

    Time frame: At the end of the liver biospy

Secondary outcomes

  1. Patient's acceptance and doctor's satisfaction

    Time frame: At the end of the liver biopsy

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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