- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258503
Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More (DOLEVA75)
The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.
So in the elderly, the noxious character of the pain is more pregnant than at the young adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to deteriorate the isolation and the dependence: the echo on the psychic state is frequent and the pain is a part of the cause of a confusional state. Finally, the presence of a pain distorts considerably the quality of life and can modify the state general as the desire of life.
The evaluation of the pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than with the real age. For that purpose, the investigators have first of all scale of self-assessment as the numerical scale which is adapted to estimate the acute and chronic pains but this scale presents a bias because, certain patients do not express spontaneously their pain and this one must be attentively looked for in case of modification of behavior.
So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within one minute a good quality evaluation whatever is the place of care) whose objective is the observation of the behavioral changes caused by the acute pain in elderly having communication disorders.
Due to the demographic evolution, emergency departments are more and more frequently a place of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all the passages in emergency department and 50 % of the patients hospitalized during the passage in the reception of Emergency department are elderly. Elderly care is difficult for a certain number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this context, the evaluation of the presence of pain and its care are difficult in particular at the elderly with communication disorders.
In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on 700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of analgesic while 13 % only had a real quotation of the pain.
The aim of the investigators study is to analyze if the systematic introduction of the scale Algoplus® in the evaluation of elderly during its entrance to emergency department could modify the prescription of analgesic.
Study Overview
Detailed Description
First period of the study :
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.
A Clinical Research Associate will collect the quotation of pain by numerical scale and the analgesics treatments prescribed and their posology and route of administration.
This data collection must be realized for 100 elderly patients of 75 or more years old admitted the Emergency department during one month.
Training period :
Training of the emergency physicians in the use of the Algoplus® scale.
Second period of the study :
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.
A Clinical Research Associate will collect the quotation of pain by numerical scale and by Algoplus® scale and the analgesics treatments prescribed and their posology and route of administration.
This data collection must be realized for 100 elderly patients of 75 or more years old admitted the Emergency department during one month.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU de Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients admitted in emergency department for any pathologies,
- Patients of 75 or more years old
Exclusion Criteria:
- Patients of less than 75 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
numerical scale
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.
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|
|
algoplus scale
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collection of the rate of prescription of analgesic treatments
Time Frame: at day 1
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collection of the score of quotation of pain by numerical scale (score from 0 to 10)
Time Frame: at day 1
|
at day 1
|
|
Collection of prescription of analgesic
Time Frame: at day 1
|
at day 1
|
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Collection of the prescription of analgesic by class according to the scale of the WHO
Time Frame: at day 1
|
at day 1
|
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Collection of the score of the scale Algoplus®
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0211
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