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Study on Midazolam and Morphine for Symptom Relief in Elderly Patients at End of Life

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on providing relief for symptoms experienced by elderly patients in their final days of life. The study involves the use of two medications: Midazolam and Morphine. These medications are commonly used to manage discomfort, pain, and other distressing symptoms such as difficulty breathing and agitation. The purpose of the study is to understand how these medications can best be used to control symptoms and to observe any side effects that may occur.

Participants in the study will receive either Midazolam or Morphine through injections, which can be given intravenously (into a vein), subcutaneously (under the skin), or intramuscularly (into a muscle). The study will monitor how quickly symptoms are relieved after the medication is administered and will also track any adverse reactions, such as nausea, vomiting, or hallucinations. The study aims to provide valuable information on the effectiveness and safety of these medications in managing end-of-life symptoms.

The trial will take place over a period of time, with each participant being observed for up to 14 days. The information gathered will help healthcare providers better understand the relationship between the dosage of these medications and their impact on symptom control and side effects. This study is an important step in improving the quality of care for elderly patients in their final days.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is admitted to the acute geriatric ward. The patient is expected to be in the last days of life, which is a requirement for participation.
Step 2
Medication administration
The patient receives two medications: morphine and midazolam. These medications are used to alleviate symptoms such as discomfort, pain, dyspnea (difficulty breathing), and agitation.
Morphine and midazolam can be administered through different routes: intravenous (into a vein), subcutaneous (under the skin), or intramuscular (into a muscle). The specific route and dosage are determined by the healthcare provider based on the patient's needs.
Step 3
Symptom monitoring
The patient's symptoms are closely monitored using various scales to assess discomfort, agitation, sedation, and dyspnea. This helps in adjusting the medication dosage to achieve optimal symptom control.
Step 4
Adverse reaction monitoring
The patient is monitored for any adverse reactions to the medications. Possible reactions include nausea, vomiting, hallucinations, constipation, muscle twitching (myoclonus), itching (pruritus), hiccups, and changes in breathing rate. Any adverse reactions are recorded and managed by the healthcare team.
Step 5
Blood and urine tests
Blood and urine samples may be collected to measure concentrations of morphine, midazolam, and their metabolites. Other blood tests may include measurements of creatinine, urea, albumin, bilirubin, and other markers to monitor the patient's overall health status.

Who can join the trial?

4 criteria

The patient must be staying in a hospital on a special unit for older adults, called the acute geriatric ward.
The patient is expected to pass away within the next few hours or days.
The study includes both male and female patients.
The study is focused on patients who are considered a vulnerable population, meaning they may need extra care and attention.

Who cannot join the trial?

7 criteria

Patients who are not in the last days of their life.
Patients who are not considered geriatric, meaning they are not older adults.
Patients who have not been experiencing symptoms like discomfort, pain, or difficulty breathing.
Patients who are not experiencing agitation.
Patients who have not been treated with **morphine** or **midazolam**. Morphine is a strong painkiller, and midazolam is a medication used to help with anxiety and agitation.
Patients who have had adverse reactions to morphine or midazolam in the past. An adverse reaction is a harmful or unwanted effect caused by the medication.
Patients who are not part of a vulnerable population, meaning they do not have special needs or circumstances that require extra care.

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Verified sites

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Morphine
is a medication used to relieve severe pain and discomfort. In this study, it is being used to help manage symptoms such as pain and difficulty breathing in elderly patients during their last days of life. The study aims to understand how different doses of morphine affect the time it takes to control these symptoms and to observe any side effects that may occur.
Midazolam
is a medication used to help with anxiety, agitation, and discomfort. In this study, it is being used to help manage symptoms such as discomfort, difficulty breathing, and agitation in elderly patients during their last days of life. The study aims to understand how different doses of midazolam affect the time it takes to control these symptoms and to observe any side effects that may occur.

What is already known about the treatment

Midazolam
Midazolam is typically administered intravenously or orally and is used to manage symptoms such as discomfort, pain, dyspnea, and agitation in geriatric patients during their last days of life. It is well-documented in medical literature as a sedative and anxiolytic. The medication works by enhancing the effect of a neurotransmitter called GABA, which helps to calm the nervous system. Midazolam is classified as a benzodiazepine.
Morphine
Morphine is usually given orally or intravenously and is used to relieve severe pain and discomfort in geriatric patients nearing the end of life. It is a well-established medication in medical literature for pain management. Morphine works by binding to opioid receptors in the brain, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Discomfort
Discomfort is a general term used to describe a feeling of unease or pain that can vary in intensity. It may be caused by various factors, including physical conditions or emotional stress. In the context of geriatric patients, discomfort can be a common experience, especially in the last days of life. It can manifest as physical pain, restlessness, or a general sense of unease. Managing discomfort is crucial to improve the quality of life for patients. The progression of discomfort can vary, often requiring careful monitoring and adjustment of care.
Pain
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It can be acute or chronic and may vary in intensity from mild to severe. In geriatric patients, pain can be a significant issue, especially in the last days of life. It can result from various medical conditions or treatments. Pain management is essential to ensure comfort and improve the quality of life. The experience of pain is subjective and can be influenced by emotional and psychological factors.
Dyspnea
Dyspnea, or shortness of breath, is a condition where an individual experiences difficulty breathing or a sensation of not getting enough air. It can be caused by various factors, including lung or heart conditions, and is common in the last days of life for geriatric patients. Dyspnea can lead to anxiety and distress, making it important to address promptly. The severity of dyspnea can fluctuate, requiring ongoing assessment and management. It is often described as a feeling of tightness in the chest or a struggle to breathe.
Agitation
Agitation is a state of restlessness and increased mental and physical activity that can be distressing for patients and caregivers. It is often seen in geriatric patients, particularly those with cognitive impairments or in the last days of life. Agitation can manifest as pacing, irritability, or an inability to stay still. It may be triggered by pain, discomfort, or environmental factors. Managing agitation involves identifying and addressing its underlying causes. The condition can vary in intensity and duration, requiring individualized care approaches.