DementiaNCT00822224
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia
A study testing MEOPA in people with Dementia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- MEOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- dementia (Folstein scoring between 0 and 25)
- older than 75
- health necessitating of painful care for example eschar care
Who cannot join
- bullous emphysema
- pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of MEOPA for Elderly With Dementia.
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.
- Conditions
- Dementia
- Being tested
- MEOPA
- Keywords
- acute pain, MEOPA, Dementia
- Medical subject headings
- Dementia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
inhalation of MEOPA during the painful care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of MEOPA during the painful care Receives: Drug: MEOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation
Measured: one time, at the first care with MEOPA
Secondary outcomes (1)
satisfaction rate of patient
Measured: one time, at the first care with MEOPA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Françoise CAPRIZ-RIBIERE, PhD, Principal investigator, Gerontology department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822224
- Sponsor's protocol ID
- 08-PP-03
- Status last verified
- Dec 2011
- First submitted
- 13 Jan 2009
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of MEOPA for Elderly With Dementia.
- ClinicalTrials.gov ID
- NCT00822224
- Acronym / sponsor ID
- 08-PP-03
- Conditions
- Dementia
- Keywords
- acute pain, MEOPA, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEOPAUse of MEOPA during the painful care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- dementia (Folstein scoring between 0 and 25)
- older than 75
- health necessitating of painful care for example eschar care
Key exclusion criteria (2 listed)
- bullous emphysema
- pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEOPAinhalation of MEOPA during the painful care | Drug | 1 |
Primary outcome
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation
Time frame: one time, at the first care with MEOPA
1 secondary outcome
satisfaction rate of patient
Time frame: one time, at the first care with MEOPA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise CAPRIZ-RIBIERE, PhD principal investigator
Gerontology department, Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEOPA in people with Dementia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation (time frame: one time, at the first care with MEOPA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011.