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

Dementia Clinical Trial

Official title:

Use of MEOPA for Elderly With Dementia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822224
• Other study ID #: 08-PP-03
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: December 8, 2011
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• MEOPA
inhalation of MEOPA during the painful care

Locations

Country	Name	City	State
France	Gerontology department, Nice University Hospital	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation		one time, at the first care with MEOPA	No
Secondary	satisfaction rate of patient		one time, at the first care with MEOPA	No