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

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Collaborators: Air Liquide Santé International; Ministry of Health, France
• Treatments: Nitrous Oxide

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