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Levomethadone Hydrochloride

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.

Table of Contents

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.[1] 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.[1] 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.[1] 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.[1]

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)[1]

Potential Benefits

The researchers are investigating several potential benefits of using Levomethadone Hydrochloride:

  1. Improved pain management after hip fracture surgery
  2. Potential reduction in overall opioid consumption
  3. Possible improvements in mobility three months after surgery
  4. Potential reduction in nausea and vomiting associated with pain and surgery
  5. Possible decrease in hospital stay duration[1]

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[1]

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.

Aspect Details
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

FAQ

  • What is the main purpose of the clinical trial using Levomethadone Hydrochloride? The main purpose is to investigate the pain-relieving effect of a single dose of methadone compared to a placebo in elderly patients undergoing acute hip fracture surgery.
  • Who is eligible to participate in this clinical trial? Eligible participants are patients diagnosed with an acute hip fracture (incurred less than 24 hours ago) on x-rays in the emergency department, including collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include multiple fractures, allergic reactions to methadone, certain health conditions like chronic obstructive pulmonary disease, impaired cognitive function, current opioid addiction, and concurrent use of specific medications.
  • What are the main outcomes being measured in this trial? The primary outcome is daily consumption of opioids. Secondary outcomes include nausea or vomiting, time to discharge, and the need for an antidote.
  • How long does the treatment period last in this trial? The maximum treatment period for the single dose of methadone is 1 day, with a maximum daily dose of 20 ml.

Ongoing Clinical Trials on Levomethadone Hydrochloride

  • Study on Methadone and Placebo for Pain Relief in Elderly Patients with Hip Fractures

    Not recruiting

    1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Levomethadone Hydrochloride: A form of methadone, which is an opioid medication used for pain relief. In this trial, it is being studied for its effectiveness in managing pain for elderly patients with hip fractures.
  • Placebo: A substance with no active medical effects, used as a control in clinical trials to compare against the actual medication being studied.
  • Hip fracture: A break in the upper part of the thigh bone (femur) near the hip joint. Types include collum femoris, pertrochanteric, and subtrochanteric fractures.
  • Opioid: A class of pain-relieving medications that work by binding to specific receptors in the brain and body to reduce pain sensations.
  • Analgesic: A medication used to relieve pain.
  • Perioperative: The time period surrounding a surgical procedure, including before, during, and after the operation.
  • Randomized controlled trial: A type of scientific study where participants are randomly assigned to different treatment groups to compare the effects of different interventions.
  • Antidote: A substance that can counteract the effects of a poison or drug, in this case, potentially used to reverse the effects of methadone if necessary.

References

  1. http://clinicaltrials.eu/trial/study-on-methadone-and-placebo-for-pain-relief-in-elderly-patients-with-hip-fractures/