NCT02230007

Brief Summary

The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication. The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person. The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

May 7, 2013

Last Update Submit

September 2, 2014

Conditions

Pain Management and Care

Outcome Measures

Primary Outcomes (1)

  • % of recovery of the hip and knee joint articular amplitude

    % of recovery of the hip and knee joint articular amplitude during 5 days after 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment; measure % of recovery of the hip and knee joint articular amplitude two times : before the beginning of the session of reeducation and at the end of the session

    5 days

Secondary Outcomes (3)

  • Measure of the pain

    5 days

  • Patients'satisfaction

    End of the period of care (up to 5 days)

  • Physiotherapists'satisfaction

    End of all the period of care (up to 5 days)

Study Arms (2)

MEOPA

EXPERIMENTAL

ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use

Drug: MEOPA

Without MEOPA

NO INTERVENTION

Physiotherapit care without MEOPA

Interventions

MEOPADRUG

3 sessions of reeducation using MEOPA

MEOPA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female aged 65 years old or more
  • Patients having a prescription for physiotherapy
  • Absence of contraindication to MEOPA
  • Patients whose initial assessment show a passive articular deficit of at least a joint of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on the validated scale Algoplus
  • Patients whose reeducation project established by the physiotherapist
  • Patients having agreed to participate in the study and having signed the consent
  • Subjects affiliated to the social security system

You may not qualify if:

  • Patient requiring a ventilation in pure oxygen
  • Patient with a consciousness deterioration preventing his cooperation
  • Care under MEOPA during the period of the protocol and during the month which precedes
  • Increase of the dosage of morphine of less than 48 hours Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pôle de Gérontologie Hôpital de Cimiez CHU de Nice

Nice, 06000, France

RECRUITING

CHU de Nice

Nice, 06003, France

NOT YET RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Meopa

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Véronique Mailland, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique MAILLAND, MD

CONTACT

0033 4 92034397mailland-putegnat@chu-nice.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

September 3, 2014

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

September 3, 2014

Record last verified: 2013-12

Locations

FR(2)