Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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 elderly hip fracture patients difficult. Perioperative methadone could improve the analgesic treatment of these patients. An earlier pilot study showed that 0.10 mg/kg was safe to use. This study further investigates the advantages of methadone. The study's objective is to investigate the analgesic effects of a single dose of methadone given during hip fracture surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern Denmark
• Treatments: Methadone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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