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

Sponsors and Collaborators:	Poitiers University Hospital Ministry of Health, France Air Liquide Santé International
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00219713

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 III

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine Nitrous oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

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

French CML Group (FI-LMC) web-site This link exits the ClinicalTrials.gov site

Study ID Numbers:	991300
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00219713
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

Nitrous oxide and oxygen
Pain
Bone marrow biopsy
Bone marrow aspiration

Study placed in the following topic categories:

Nitrous Oxide
Lidocaine
Pain

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009