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

Air Liquide Santé International94 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Liver Biopsy

Interventions

Kalinox 170 barDRUG

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

Mix of 50% oxygen and 50% nitrogenDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beaujon hospital

Clichy, France

Outcomes

Primary Outcomes

Pain measurement by using Visual Analog Scale (VAS)

Time frame: At the end of the liver biospy

Secondary Outcomes

Patient's acceptance and doctor's satisfaction

Time frame: At the end of the liver biopsy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.