NCT00643656CompletedPhase 4
Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion
Air Liquide Santé International1 site in 1 country94 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Pain measurement by using Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A
Experimental
Mixture of 50% nitrous oxide and 50% oxygen
Intervention: Kalinox 170 bar (Drug)
B
Placebo Comparator
Mixture of 50% oxygen and 50% nitrogen
Intervention: Mix of 50% oxygen and 50% nitrogen (Drug)
Outcomes
Primary Outcomes
Pain measurement by using Visual Analog Scale (VAS)
Time Frame: At the end of the liver biospy
Secondary Outcomes
- Patient's acceptance and doctor's satisfaction(At the end of the liver biopsy)
Investigators
Study Sites (1)
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