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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219713
• Other study ID #: 991300
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: March 2000
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 280
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• nitrous oxide and oxygen

Locations

Country	Name	City	State
France	University Hospital	Poitiers

Sponsors (3)

Lead Sponsor	Collaborator
Poitiers University Hospital	Air Liquide Santé International, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce pain during bone marrow biopsy with aspiration.
Secondary	Tolerability
Secondary	Evaluation of the quality of the picture sample

External Links

•   French CML Group (FI-LMC) web-site