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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.

Primary Purpose

Pain

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
nitrous oxide and oxygen
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Nitrous oxide and oxygen, Pain, Bone marrow biopsy, Bone marrow aspiration

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Outcomes

Primary Outcome Measures

Reduce pain during bone marrow biopsy with aspiration.

Secondary Outcome Measures

Tolerability
Evaluation of the quality of the picture sample

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Poitiers University Hospital
Collaborators
Ministry of Health, France, Air Liquide Santé International
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1. Study Identification

Unique Protocol Identification Number
NCT00219713
Brief Title
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Poitiers University Hospital
Collaborators
Ministry of Health, France, Air Liquide Santé International

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Nitrous oxide and oxygen, Pain, Bone marrow biopsy, Bone marrow aspiration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
280 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nitrous oxide and oxygen
Primary Outcome Measure Information:
Title
Reduce pain during bone marrow biopsy with aspiration.
Secondary Outcome Measure Information:
Title
Tolerability
Title
Evaluation of the quality of the picture sample

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GUILHOT, MD
Organizational Affiliation
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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