Liver Biopsy
Conditions
Keywords
Liver biopsy
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.
Interventions
DRUGKalinox 170 bar
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
DRUGMix of 50% oxygen and 50% nitrogen
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
Sponsors
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measurement by using Visual Analog Scale (VAS) | At the end of the liver biospy |
Secondary
| Measure | Time frame |
|---|---|
| Patient's acceptance and doctor's satisfaction | At the end of the liver biopsy |
Countries
France
Outcome results
None listed