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

September 13, 2005
September 13, 2005
March 2000
Not Provided
Reduce pain during bone marrow biopsy with aspiration.
Same as current
No Changes Posted
  • Tolerability
  • Evaluation of the quality of the picture sample
Same as current
Not Provided
Not Provided
 
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
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.

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Pain
Drug: nitrous oxide and oxygen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
280
December 2004
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00219713
991300
Not Provided
Not Provided
Poitiers University Hospital
  • Ministry of Health, France
  • Air Liquide Santé International
Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Poitiers University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP