Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.

Tracking Information
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; (submitted: September 13, 2005)	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; (submitted: September 13, 2005)	Tolerability; Evaluation of the quality of the picture sample
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
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
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.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: September 13, 2005)	280
Original Enrollment ICMJE	Same as current
Study Completion Date	December 2004
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Patients 18 years of age or older; with a good clinical condition (score ECOG < 2); without contra indication for the use of nitrous oxide or previous medical history of allergy to Xylocaïne.; Informed consent signed up. Exclusion Criteria: pregnancy,; prior exposure to nitrous oxide,; patients with neurological illness and those on anti depressant medications or with congestive heart failure or significant respiratory disease.; patients on analgesia for other medical conditions or whose with the inability to provided consent of an assessment of pain.; patients with platelet dysfunction or related coagulation disorders, aspirin or warfarin therapy
Sex/Gender	Sexes Eligible for Study: All
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	Ministry of Health, France; Air Liquide Santé International
Investigators ICMJE	Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
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