Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
NCT00219713 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2005-09-22
Summary
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
Conditions
Interventions
- DRUG
-
nitrous oxide and oxygen
Sponsors & Collaborators
-
Ministry of Health, France
collaborator OTHER_GOV -
Air Liquide Santé International
collaborator INDUSTRY -
Poitiers University Hospital
lead OTHER
Principal Investigators
-
François GUILHOT, MD · Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-03-31
- Completion
- 2004-12-31
Countries
- France
Study Locations
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