Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion
Phase 4
Completed
- Conditions
- Liver Biopsy
- Interventions
- Drug: Kalinox 170 barDrug: Mix of 50% oxygen and 50% nitrogen
- Registration Number
- NCT00643656
- Lead Sponsor
- Air Liquide Santé International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Kalinox 170 bar Mixture of 50% nitrous oxide and 50% oxygen B Mix of 50% oxygen and 50% nitrogen Mixture of 50% oxygen and 50% nitrogen
- Primary Outcome Measures
Name Time Method Pain measurement by using Visual Analog Scale (VAS) At the end of the liver biospy
- Secondary Outcome Measures
Name Time Method Patient's acceptance and doctor's satisfaction At the end of the liver biopsy
Trial Locations
- Locations (1)
Beaujon hospital
🇫🇷Clichy, France