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

Air Liquide

Status and phase: Completed; Phase 4

Conditions: Liver Biopsy

Treatments: Drug: Kalinox 170 bar; Drug: Mix of 50% oxygen and 50% nitrogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643656

EudraCT : 2006-004203-19

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Mixture of 50% nitrous oxide and 50% oxygen

Treatment:

Drug: Kalinox 170 bar

B

Placebo Comparator group

Description:

Mixture of 50% oxygen and 50% nitrogen

Treatment:

Drug: Mix of 50% oxygen and 50% nitrogen