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

This study has been terminated.

Sponsor:

Collaborators:

Ministry of Health, France

Air Liquide Santé International

Information provided by:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT00219713

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

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

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-Blind
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

280

Estimated 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

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

Plan to Share Data

Not Provided

IPD Description

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

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