Status:
TERMINATED
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Ministry of Health, France
Air Liquide Santé International
Conditions:
Pain
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 referre...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00219713
Start Date
March 1 2000
End Date
December 1 2004
Last Update
September 22 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Poitiers, France, 86021