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

NCT00643656 | Completed Phase 4

• 1 other identifier: EudraCT : 2006-004203-19
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Biopsy

Keywords

Liver biopsy

Outcome Measures

Primary Outcomes (1)

• Pain measurement by using Visual Analog Scale (VAS)

  At the end of the liver biospy

Secondary Outcomes (1)

• Patient's acceptance and doctor's satisfaction

  At the end of the liver biopsy

Study Arms (2)

A

EXPERIMENTAL

Mixture of 50% nitrous oxide and 50% oxygen

Drug: Kalinox 170 bar

B

PLACEBO COMPARATOR

Mixture of 50% oxygen and 50% nitrogen

Drug: Mix of 50% oxygen and 50% nitrogen

Interventions

Kalinox 170 bar DRUG

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

A

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient requiring a liver biopsy of focal lesion
• Age upper than 18 years
• OMS : 0 to 3
• patient consent form signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead

Study Sites (1)

Beaujon hospital

Clichy, 92118, France

Location

Related Publications (1)

• Meskine N, Vullierme MP, Zappa M, d'Assignies G, Sibert A, Vilgrain V. Evaluation of analgesic effect of equimolar mixture of oxygen and nitrous oxide inhalation during percutaneous biopsy of focal liver lesions: a double-blind randomized study. Acad Radiol. 2011 Jul;18(7):816-21. doi: 10.1016/j.acra.2011.01.025. Epub 2011 Apr 20.

  PMID: 21511500 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Oxygen; Nitrogen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

FR (1)