Perioperative methadone compared to placebo in elderly hip fracture patients – a randomized controlled trial. Phase two of the MetaHip trial
- Conditions
- Hip fracturesMedDRA version: 20.1Level: LLTClassification code: 10053653Term: Femur fracture subtrochanteric Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017216Term: Fracture of subtrochanteric section of femur closed Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017096Term: Fracture of base of neck of femur closed Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017163Term: Fracture of neck of femur Class: 10022117MedDRA version: 20.1Level: LLTClassification code: 10017236Term: Fracture of unspecified part of neck of femur closed Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017228Term: Fracture of unspecified intracapsular section of neck of femur closed Class: 10022117MedDRA version: 20.1Level: LLTClassification code: 10034736Term: Pertrochanteric fracture of femur closed Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017159Term: Fracture of midcervical section of femur closed Class: 10022117MedDRA version: 20.0Level: LLTClassification code: 10017130Term: Fracture of intertrochanteric section of femur closed Class: 10022117
- Registration Number
- CTIS2023-506252-24-00
- Lead Sponsor
- Sygehus Soenderjylland Soenderborg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the analgesic effect of a single dose of methadone compared with a placebo in acute hip fracture surgery.;Secondary Objective: To investigate the long-term effects of methadone on continued opioid consumption, pain, and mobility three months after surgery.;Primary end point(s): Daily consumption of opioids
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Pain;Secondary end point(s):Standing up;Secondary end point(s):Mobility;Secondary end point(s):Nausea or vomiting;Secondary end point(s):Time to discharge;Secondary end point(s):Need for an antidote;Secondary end point(s):Delirium;Secondary end point(s):Constipation