Pain in Elderly Patients Having Communication Disorders. Clinical Trial
— CALDOLOfficial title:
Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.
The pain of the elderly is often trivialized and ignored in spite of its high 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.
The evaluation of 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 to the real
age. For that purpose, the investigators have self-assessment scales as the Numeric Pain
Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a
bias because, some patients do not express spontaneously their pain.
So behavioural scales were elaborated to solve the difficulties of detection and to care the
pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be
completed) whose objective is the observation of behavioural changes caused by the acute
pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in
few minutes a good evaluation of pain) whose objective is the observation of behavioural
changes caused by the chronic pain in elderly having communication impairments.
In practice, because of its popularity, the Algoplus® scale is widely used out of the
specificity in which it has been validated. Practitioners, worried about this misuse,
suggested to Doloplus® group, to test the concordance between the two behavioural scales in
order to develop recommendations more targeted. The risk is that the use of the Algoplus®
scale may underestimate pain that would have been detected by Doloplus® scale, and lead to
under-treatment or non-treatment of pain in elderly having communication disorders.
This study aims to establish the concordance between these two scales to generate advices
and recommendations to assess efficiently the pain in this vulnerable population.
The main objective of this study is to assess whether the use of Algoplus® scale is in good
concordance with Doloplus® scale.
The secondary objective of this study is to assess the concordance with different levels of
Algoplus® pain scale: (0-1), (2-3), (4-5).
| Status | Recruiting |
| Enrollment | 210 |
| Est. completion date | September 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - Patients of 65 or more years old - Patients having communication disorders - Hospitalization for at least 48 hours Exclusion Criteria: - Patients of less than 65 years |
Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Dr Anne-Cécile BOURJAL - Investigator, Dr Bernard WARY- Investigator, Dr Catherine BLUNTZ - Investigator, Dr Chandra COLOM - Investigator, Dr Cyril GUILLAUME - Investigator, Dr Françoise CAPRIZ - Investigator, Dr Jean-François VILLARD - Investigator, Dr Jérôme BOHATIER – Investigator, Dr Marie FLOCCIA - Investigator, Dr Micheline MICHEL - Investigator, Dr Patrice RAT - Investigator, Dr Sylvie CHAPIRO- Investigator, Dr Yves PASSADORI - Investigator, Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center, Mr Dieudonné ENDOUGOU - Collaborator, Ms Joëlle DEVOT - Collaborator, Ms Linh NGUYEN PHUONG - Collaborator, Ms Nathalie DANNENBERGER - Collaborator, Ms Nathalie ROUX - Collaborator |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain scores on Algoplus® and Doloplus® pain scales | at 48 hours after patients' admission in the care service. | Yes | |
| Secondary | Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5) | at 48 hours after patients' admission in the care service. | Yes |