Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and... | NCT00822224

Studies
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia

NCT00822224

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Dec 9, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Dementia

Interventions

MEOPA

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 13, 2009

First Submission Date that Met QC Criteria

Jan 13, 2009

First Posted Date

Jan 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2011

Last Update Posted Date

Dec 9, 2011Estimated

Name	Class
Fondation de France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Use of MEOPA during the painful care	Drug: MEOPA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MEOPA	Drug	inhalation of MEOPA during the painful care	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation		one time, at the first care with MEOPA

Secondary Outcomes

Measure	Description	Time Frame
satisfaction rate of patient		one time, at the first care with MEOPA

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Françoise CAPRIZ-RIBIERE, PhD	Gerontology department, Nice University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gerontology department, Nice University Hospital		Nice		06000	France

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D059787	Acute Pain

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C576493	Meopa

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided