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

This study has been completed.
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00822224
First received: January 13, 2009
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Dementia
 Drug: MEOPA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of MEOPA for Elderly With Dementia.

Resource links provided by NLM:

MedlinePlus related topics: Dementia
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation [ Time Frame: one time, at the first care with MEOPA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • satisfaction rate of patient [ Time Frame: one time, at the first care with MEOPA ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Use of MEOPA during the painful care
 Drug: MEOPA
inhalation of MEOPA during the painful care

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822224

Locations
France
Gerontology department, Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Fondation de France
Investigators
Principal Investigator: Françoise CAPRIZ-RIBIERE, PhD Gerontology department, Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00822224     History of Changes
Other Study ID Numbers: 08-PP-03
Study First Received: January 13, 2009
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
acute pain
MEOPA
Dementia

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013