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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Nitrous oxide and oxygen Pain Bone marrow biopsy Bone marrow aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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nitrous oxide and oxygen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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François GUILHOT, MD

Role: STUDY_CHAIR

Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Locations

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University Hospital

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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991300

Identifier Type: -

Identifier Source: org_study_id