Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219713
Status:
TERMINATED
Last Update Posted:
2005-09-22
First Post:
2005-09-13
Brief Title:
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None