NCT00822224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

Enrollment Period

2.9 years

First QC Date

January 13, 2009

Last Update Submit

December 8, 2011

Conditions

Dementia

Keywords

acute painMEOPADementia

Outcome Measures

Primary Outcomes (1)

  • feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation

    one time, at the first care with MEOPA

Secondary Outcomes (1)

  • satisfaction rate of patient

    one time, at the first care with MEOPA

Study Arms (1)

1

EXPERIMENTAL

Use of MEOPA during the painful care

Drug: MEOPA

Interventions

MEOPADRUG

inhalation of MEOPA during the painful care

1

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • dementia (Folstein scoring between 0 and 25)
  • older than 75
  • health necessitating of painful care for example eschar care

You may not qualify if:

  • bullous emphysema
  • pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerontology department, Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

DementiaAcute Pain

Interventions

Meopa

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Françoise CAPRIZ-RIBIERE, PhD

    Gerontology department, Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations

FR(1)