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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Liver Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Mixture of 50% nitrous oxide and 50% oxygen

Group Type EXPERIMENTAL

Kalinox 170 bar

Intervention Type DRUG

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

B

Mixture of 50% oxygen and 50% nitrogen

Group Type PLACEBO_COMPARATOR

Mix of 50% oxygen and 50% nitrogen

Intervention Type DRUG

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

Interventions

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Kalinox 170 bar

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No