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
  Purpose

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 Intervention Phase
Pain
Drug: nitrous oxide and oxygen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

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

Secondary Outcome Measures:
  • Tolerability
  • Evaluation of the quality of the picture sample

Estimated Enrollment: 280
Study Start Date: March 2000
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00219713     History of Changes
Other Study ID Numbers: 991300
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014