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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Mixture of 50% nitrous oxide and 50% oxygen |
|
| B | Placebo Comparator | Mixture of 50% oxygen and 50% nitrogen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kalinox 170 bar | Drug | Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurement by using Visual Analog Scale (VAS) | At the end of the liver biospy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's acceptance and doctor's satisfaction | At the end of the liver biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaujon hospital | Clichy | 92118 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21511500 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| 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 |
|