Back to resultsUse of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MEOPA
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring acute pain, MEOPA, Dementia
Eligibility Criteria
Inclusion Criteria:
- dementia (Folstein scoring between 0 and 25)
- older than 75
- health necessitating of painful care for example eschar care
Exclusion Criteria:
- bullous emphysema
- pneumothorax
Sites / Locations
- Gerontology department, Nice University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Use of MEOPA during the painful care
Outcomes
Primary Outcome Measures
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation
Secondary Outcome Measures
satisfaction rate of patient
Full Information
NCT ID
NCT00822224
First Posted
January 13, 2009
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Fondation de France
1. Study Identification
Unique Protocol Identification Number
NCT00822224
Brief Title
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia
Official Title
Use of MEOPA for Elderly With Dementia.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Fondation de France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring.
MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers.
In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
acute pain, MEOPA, Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Use of MEOPA during the painful care
Intervention Type
Drug
Intervention Name(s)
MEOPA
Intervention Description
inhalation of MEOPA during the painful care
Primary Outcome Measure Information:
Title
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation
Time Frame
one time, at the first care with MEOPA
Secondary Outcome Measure Information:
Title
satisfaction rate of patient
Time Frame
one time, at the first care with MEOPA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dementia (Folstein scoring between 0 and 25)
older than 75
health necessitating of painful care for example eschar care
Exclusion Criteria:
bullous emphysema
pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise CAPRIZ-RIBIERE, PhD
Organizational Affiliation
Gerontology department, Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerontology department, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia
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