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Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales

Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02174744
Acronym
CALDOL
Enrollment
210
Registered
2014-06-26
Start date
2014-01-31
Completion date
2014-09-30
Last updated
2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in Elderly Patients Having Communication Disorders.

Keywords

Pain in elderly patients having communication disorders, Numerical scale, Algoplus® scale, Doloplus® scale

Brief summary

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).

Detailed description

The physician investigator will identify and include patients in the study according to the inclusion criteria. Management of patients do not differ from the usual care in the service concerned. During the usual patient care, several pain assessments will be performed: Numeric Pain Rating Scale, MMSE score if the patient is able to communicate, Algoplus® scale and Doloplus® scale will be performed by doctors and/or caregivers without patient's participation. The patient will be assessed by two doctors and or caregivers (the time interval between the two assessments must be as short as possible). In a first step, 48 hours after patient admission in the care service, a first doctor/caregiver will assess pain with Numeric Pain Rating Scale and evaluate MMSE score if it is possible and then assess pain with the Algoplus® scale. The results of the Numeric Pain Rating Scale, the Algoplus® scale and the MMSE score will be recorded in the medical record and in the study Case Report Form. In a second step, less than 3 hours after the first assessment, a second doctor/caregiver will assess pain with the Doloplus® scale and the result will be recorded in the medical record and in the study Case Report Form. The Case Report Form (containing demographic data, the history of pain, analgesics treatment, scores of Numeric Pain Rating Scale, MMSE, Algoplus® scale and Doloplus® scale) will be faxed to the Coordinating Center at Clermont-Ferrand in the day.

Interventions

Sponsors

Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center
CollaboratorUNKNOWN
Ms Joëlle DEVOT - Collaborator
CollaboratorUNKNOWN
Dr Patrice RAT - Investigator
CollaboratorUNKNOWN
Dr Chandra COLOM - Investigator
CollaboratorUNKNOWN
Mr Dieudonné ENDOUGOU - Collaborator
CollaboratorUNKNOWN
Dr Cyril GUILLAUME - Investigator
CollaboratorUNKNOWN
Ms Nathalie ROUX - Collaborator
CollaboratorUNKNOWN
Dr Yves PASSADORI - Investigator
CollaboratorUNKNOWN
Ms Nathalie DANNENBERGER - Collaborator
CollaboratorUNKNOWN
Dr Micheline MICHEL - Investigator
CollaboratorUNKNOWN
Dr Sylvie CHAPIRO- Investigator
CollaboratorUNKNOWN
Dr Jean-François VILLARD - Investigator
CollaboratorUNKNOWN
Dr Bernard WARY- Investigator
CollaboratorUNKNOWN
Dr Anne-Cécile BOURJAL - Investigator
CollaboratorUNKNOWN
Dr Catherine BLUNTZ - Investigator
CollaboratorUNKNOWN
Dr Françoise CAPRIZ - Investigator
CollaboratorUNKNOWN
Dr Marie FLOCCIA - Investigator
CollaboratorUNKNOWN
Dr Jérôme BOHATIER - Investigator
CollaboratorUNKNOWN
Ms Linh NGUYEN PHUONG - Collaborator
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain scores on Algoplus® and Doloplus® pain scalesat 48 hours after patients' admission in the care service.

Secondary

MeasureTime frame
Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5)at 48 hours after patients' admission in the care service.

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026