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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Air Liquide Santé International | INDUSTRY |
Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.
Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler
The efficacy of an inhaled equimolar mixture of nitrous oxide and oxygen to prevent procedural pain during lumbar puncture in children has been demonstrated. In adults the use of an inhaled equimolar mixture could prevent pain.
Although nitrous oxide was initially considered innocuous, evidence began to be gathered later that it had potentially side effect. It has been demonstrated that nitrous oxide inactivates the vitamin B12-dependent enzyme methionine synthetase and impairs DNA synthesis in bone marrow cells.
Therefore this prospective, multicenter randomized placebo controlled, double-blind trial was design to determine whether an inhaled equimolar mixture of nitrous oxide and oxygen would significantly reduce pain during bone marrow biopsy with aspiration. In addition we performed a careful cytological examination of bone marrow samples in order to evaluate the quality of the picture sample.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitrous oxide and oxygen | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce pain during bone marrow biopsy with aspiration. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | ||
| Evaluation of the quality of the picture sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François GUILHOT, MD | Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Poitiers | 86021 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |