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Perioperative methadone compared to placebo in elderly hip fracture patients – a randomized controlled trial. Phase two of the MetaHip trial
EU CTIS ID: 2023-506252-24-00
What this study is testing
To investigate the analgesic effect of a single dose of methadone compared with a placebo in acute hip fracture surgery.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with an acute hip fracture (incurred <24 hours ago) on x-rays in the emergency department. This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- Age ≥ 60 years.
You likely can't join if
- Multiple fractures.
- 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).
- 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 supplementary analgesics if needed.
See the full eligibility criteria
- Patients diagnosed with an acute hip fracture (incurred <24 hours ago) on x-rays in the emergency department. This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- Age ≥ 60 years.
- Multiple fractures.
- 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).
- 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 supplementary analgesics if needed.
- Current opioid addiction or intravenous addiction.
- Multi-trauma patient
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.