Delirium
Conditions
Interventions
Patients will be randomized and allocated to one of two pain treatment
strategies:
1. Intervention
Ultrasound-guided administration of a continuous FICB, employing catheter
technique, whereby the c
traditional care
In moderate and severe pain, the current national guideline for pharmacological
treatment of acute traumatic pain advises systemic opioids as first choice and
morphine as first line
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients 55 years and older - Presenting to the Emergency Department (ED) - With a hip fracture
Exclusion criteria
Exclusion criteria: - Polytrauma patients; patients with other fractures or significant injuries - Patients already delirious at moment of presentation at ED - Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the occurrence of delirium during the entire hospital stay, until three months after discharge from the hospital. The diagnosis delirium is clinically based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), the Confusion Assessment Method (CAM) or CAM-ICU in critical care or in recovery room after surgery by a physician trained and competent in making this diagnosis (clinician specialized in geriatrics, internal medicine, neurology or a nursing home physician or family doctor) and trained research nurses. During hospital admission, the Delirium Observation Screening Scale will be completed during each nursing shift. In case the DOS final score is 3 or higher, the patient is most probably delirious and the geriatrician on call is consulted. If the diagnosis is confirmed, this is reported in standard case report forms and the patient is treated for the delirium on discretion of the treating geriatrician. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration (defined as the total number of days with delirium) and the severity (percentage of patients with duration > 2 days) of delirium; - Pain (NRS pain scores during complete hospital stay, as well as need for rescue analgesia); - Satisfaction of patients and health care staff regarding efficacy of pain treatment and method of pain treatment in the ED and daily during hospital admission (5-point Likert scales and reference questions); - Hospital stay characteristics (length of stay, ICU admission and ICU length of stay, hospital re-admission rate, occurrence of complications of hip surgery and medical complications, all cause in-hospital-mortality and mortality after hospital discharge); - Functional status: - (15-item modified Katz Index of Activities of Daily Living) based on 2 weeks before presentation and after 3 months; - The Oxford Hip Score after 3 months; - Generic HRQol (Euroqol - EQ-5D-5L) at 3 months; - Cognitive function (Mini Mental State Examination at inclusion, at discharge and at 3 months; - Economic evaluation (cost-effectiveness and cost-utility analysis), QALY's calculated by product sum of utility of each health state (EQ-5D-5L) and times in between observations, direct and indirect medical and non-medical costs, health-related costs of patients and family. - Baseline parameters: time of presentation at Emergency Department and time to application of the intervention or administration of analgesics, age, sex, medical history and medication use, type of hip fracture (medial or lateral collum fracture, per- or inter-trochanteric). | — |
Countries
Netherlands
Outcome results
None listed