In short
This article discusses the use of Levomethadone Hydrochloride, also known as methadone, in clinical trials for pain management in elderly patients with hip fractures. The study, called the MetaHip trial, aims to investigate the effectiveness of a single dose of methadone compared to a placebo for pain relief during acute hip fracture surgery and its long-term effects on opioid consumption, pain, and mobility.
At a glance
- Study Name
- MetaHip trial (Phase two)
- Drug Studied
- Levomethadone Hydrochloride (Methadone)
- Main Objective
- Investigate analgesic effect of single-dose methadone vs. placebo in acute hip fracture surgery
- Secondary Objective
- Investigate long-term effects on opioid consumption, pain, and mobility after 3 months
- Eligible Participants
- Patients with acute hip fracture (less than 24 hours old)
- Primary Outcome
- Daily consumption of opioids
- Key Secondary Outcomes
- Nausea/vomiting, time to discharge, need for antidote
- Maximum Daily Dose
- 20 ml
- Treatment Duration
- 1 day (single dose)
- Administration Route
- Intravenous
What is Levomethadone Hydrochloride?
Levomethadone Hydrochloride is a medication that belongs to the opioid class of drugs. It is also known by several other names, including (-)-6-dimethylamino-4,4-diphenylheptan-3-one hydrochloride and (-)-methadone hydrochloride. This medication is a form of methadone, which is commonly used for pain relief and in the treatment of opioid addiction.
Medical Uses
Levomethadone Hydrochloride is primarily used for pain management. In the context of the clinical trial discussed here, it is being studied for its potential in providing pain relief for elderly patients with hip fractures. Hip fractures can be extremely painful, and effective pain management is crucial for patient comfort and recovery.
Administration
In the clinical trial, Levomethadone Hydrochloride is administered intravenously. This means it is given directly into a vein. The maximum daily dose being used in the study is 20 milliliters. It's important to note that this dosage is specific to the trial and may not reflect typical usage outside of research settings.
Current Clinical Trial
A clinical trial is currently underway to investigate the effectiveness of Levomethadone Hydrochloride in managing pain for elderly patients with hip fractures. The study, titled "Perioperative methadone compared to placebo in elderly hip fracture patients – a randomized controlled trial," aims to compare the pain-relieving effects of a single dose of methadone to a placebo in patients undergoing acute hip fracture surgery.
Eligibility Criteria
To participate in this study, patients must meet specific criteria:
- Diagnosed with an acute hip fracture (occurred less than 24 hours ago)
- Types of fractures included: collum femoris fractures (fractures of the neck of the femur), pertrochanteric fractures (fractures near the upper part of the thighbone), and subtrochanteric fractures (fractures slightly below the hip joint)
Potential Benefits
The researchers are investigating several potential benefits of using Levomethadone Hydrochloride:
- Improved pain management after hip fracture surgery
- Potential reduction in overall opioid consumption
- Possible improvements in mobility three months after surgery
- Potential reduction in nausea and vomiting associated with pain and surgery
- Possible decrease in hospital stay duration
Precautions and Exclusions
While Levomethadone Hydrochloride may offer benefits, it's not suitable for everyone. The study excludes patients with:
- Multiple fractures or multi-trauma injuries
- Allergies to methadone hydrochloride or sodium chloride
- Certain health conditions, including:
- Chronic obstructive pulmonary disease (COPD) with past exacerbations or daily symptoms
- History of acute asthma attacks
- Pulmonary hypertension (high blood pressure in the lungs)
- Raised intracranial pressure or recent head injury
- Pheochromocytoma (a rare tumor of the adrenal glands)
- History of paralytic ileus (a condition where the intestines become paralyzed)
- QT-interval prolongation on electrocardiogram (ECG)
- Myasthenia gravis (a neuromuscular disorder)
- Known liver disorders
- Low blood pressure (systolic blood pressure below 100 mmHg at admission)
- Current use of MAO inhibitors or recent discontinuation (within 2 weeks)
- Concurrent use of benzodiazepines
- Impaired cognitive function (e.g., dementia)
- Current opioid addiction or intravenous drug use
It's crucial to discuss any medical conditions or medications with your healthcare provider before considering treatment with Levomethadone Hydrochloride or participating in clinical trials.