Status:
COMPLETED
Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients
Lead Sponsor:
University of Southern Denmark
Conditions:
Hip Fractures
Methadone
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Hip fractures are associated with severe pain and are sustained by the elderly population. Demand for adequate pain relief combined with a low tolerance for analgesic drugs makes the treatment of elde...
Detailed Description
Studies investigating the perioperative use of methadone have shown promising analgesic properties. Our pilot study (EudraCT no.: 2022-001857-22) showed that a dosage of 0.10 mg/kg was safe to use and...
Eligibility Criteria
Inclusion
- Patients diagnosed with an acute hip fracture (incurred \<24 hours ago) on x-rays in the emergency department (ED) at the university hospital of southern Denmark (SHS). This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- Patients must be able to read and understand Danish.
Exclusion
- Multiple fractures or multi-trauma patient
- Previous allergic reactions or hypersensitivity towards methadone hydrochloride or sodium chloride
- Health conditions preventing treatment:
- Chronic obstructive pulmonary disease with either past exacerbations or daily symptoms History of acute asthma attacks History of drug-induced eczema Pulmonary hypertension Raised intracranial pressure or recent head injury Pheochromocytoma History of paralytic ileus QT-interval prolongation on electrocardiogram (ECG) Myasthenia gravis Known liver disorder Hypotension (systolic blood pressure \<100 mmHg at admission) Acute pancreatitis Severe kidney disease (GFR ≤10)
- Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products
- Concurrent administration of benzodiazepines
- Impaired cognitive function e.g. dementia. Patients must be able to give informed consent and be able to ask for rescue analgesics if needed
- Current opioid addiction or intravenous addiction
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT06086171
Start Date
November 10 2023
End Date
February 21 2025
Last Update
March 18 2025
Active Locations (1)
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1
Sygehus Sønderjylland
Aabenraa, Southern Denmark, Denmark, 6200