Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
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ClinicalTrials.gov Identifier: NCT00219713 |
Recruitment Status
:
Terminated
First Posted
: September 22, 2005
Last Update Posted
: September 22, 2005
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Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Last Update Posted Date | September 22, 2005 | |||
Study Start Date ICMJE | March 2000 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Reduce pain during bone marrow biopsy with aspiration. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture. | |||
Official Title ICMJE | A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy. | |||
Brief 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 |
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Detailed Description | 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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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | Pain | |||
Intervention ICMJE | Drug: nitrous oxide and oxygen | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE |
280 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | December 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00219713 | |||
Other Study ID Numbers ICMJE | 991300 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Poitiers University Hospital | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Poitiers University Hospital | |||
Verification Date | September 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |