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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

Dobutamine Hydrochloride

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.

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.

Trial ID:

2024-517763-22-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?