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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00219713
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
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


Condition or disease Intervention/treatment Phase
Pain Drug: nitrous oxide and oxygen Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : March 2000
Estimated Study Completion Date : December 2004

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Reduce pain during bone marrow biopsy with aspiration.

Secondary Outcome Measures :
  1. Tolerability
  2. Evaluation of the quality of the picture sample

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219713


Locations
France
University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Ministry of Health, France
Air Liquide Santé International
Investigators
Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00219713     History of Changes
Other Study ID Numbers: 991300
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

Keywords provided by Poitiers University Hospital:
Nitrous oxide and oxygen
Pain
Bone marrow biopsy
Bone marrow aspiration

Additional relevant MeSH terms:
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents