Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"

Cognitive Deterioration Clinical Trial

— ALGOGER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056934
• Other study ID #: Local/2023
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: GAULTIER
• Phone: O6.05.16.89.71
• Email: josephine.gaultier[@]free.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 76 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Deterioration
• Frailty

Locations

Country	Name	City	State
France	GAULTIER	Nîmes	CHU De Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine sulfate equivalent rate in each group, mg/day	mg/day	Pre-operative
Primary	Morphine sulfate equivalent rate in each group, mg/day	mg/day	Early post-operative between Day 0 and Day 3
Primary	Morphine sulfate equivalent rate in each group, mg/day	mg/day	Late post-operative between Day 4 and day 7