- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06056934
Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER" (ALGOGER)
Retrospective Study of Protocol-based Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized at UPOG for Fracture of the Upper Extremity of the Femur in 2022
Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions.
Surgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic.
Adequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them.
Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes.
Pain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management.
The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: GAULTIER
- Phone Number: O6.05.16.89.71
- Email: josephine.gaultier@free.fr
Study Contact Backup
- Name: SIMONET
- Phone Number: 0466685148
- Email: anne.clarisse.simonet@chu-nimes.fr
Study Locations
-
-
CHU De Nîmes
-
Nîmes, CHU De Nîmes, France, 30029
- Recruiting
- GAULTIER
-
Contact:
- SIMONET
- Phone Number: 0466685148
- Email: anne.clarisse.simonet@chu-nimes.fr
-
Principal Investigator:
- GERONIMI-ROBELIN
-
Sub-Investigator:
- GAULTIER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged > 75 years
- Hospitalized for a fracture of the upper extremity of the femur at the UPOG of the CHU de Nîmes during 2022
Exclusion Criteria:
- Opioid allergy
- No surgical management of fracture
- Long-term treatment with high-dose opiates
- Patient has objected to the use of his or her data.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Pre-operative
|
mg/day
|
Pre-operative
|
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Early post-operative between Day 0 and Day 3
|
mg/day
|
Early post-operative between Day 0 and Day 3
|
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Late post-operative between Day 4 and day 7
|
mg/day
|
Late post-operative between Day 4 and day 7
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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