Study on Midazolam Hydrochloride: Comparing Subcutaneous and Intravenous Use in Adults with Terminal Illness in Palliative Care

2 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of Midazolam, a medication used to help manage symptoms such as anxiety, restlessness, agitation, and difficulty breathing in patients who are terminally ill and receiving palliative care. Palliative care is specialized medical care aimed at providing relief from the symptoms and stress of a serious illness. The study will compare two ways of giving Midazolam: through a subcutaneous injection, which is an injection under the skin, and an intravenous injection, which is an injection directly into a vein.

The purpose of the study is to understand how the body absorbs and processes Midazolam when given by these two different methods. This will help determine which method might be more effective or comfortable for patients. The study will involve adult men and women who are terminally ill and have a life expectancy of less than one month. Participants will receive either the subcutaneous or intravenous form of Midazolam to help manage their symptoms.

Throughout the study, researchers will monitor how the medication is absorbed in the body and any changes in symptoms or side effects. This includes checking for any discomfort at the injection site and changes in breathing or oxygen levels. The study aims to provide valuable information that could improve symptom management for terminally ill patients in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide signed informed consent, confirming understanding and agreement to comply with the study requirements.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying that the patient is terminally ill, receiving palliative care, and has a life expectancy of less than one month. The attending physician will determine if the patient is suitable for the administration of midazolam.

3 medication administration

The patient will receive midazolam, a medication used to manage symptoms such as anxiety and restlessness. The medication will be administered either as a subcutaneous injection (under the skin) or an intravenous injection (into a vein). The dosage will be 1 mg of midazolam.

4 monitoring and sample collection

After the administration of midazolam, the patient’s blood samples will be collected at specific intervals: 2, 5, 7, 10, 12, 15, 20, 25, 30, 40, 50, 60, 75, and 90 minutes. These samples will help measure the amount of midazolam in the blood over time.

The patient’s respiratory rate, oxygen levels, and sedation levels will also be monitored at 10, 20, 30, 40, 50, 60, 75, and 90 minutes after administration.

5 evaluation of side effects

The patient will be observed for any discomfort at the injection site, such as pain, redness, swelling, or itching. Any changes in the patient’s condition will be recorded.

6 follow-up and conclusion

The study will conclude after the final monitoring and sample collection. The patient will be informed about the next steps and any additional care required.

Who Can Join the Study?

Patients must have a terminal illness and need care that focuses on comfort rather than cure.
Patients should have a life expectancy of less than one month.
Patients must be receiving palliative care, which is specialized medical care for people with serious illnesses, focusing on providing relief from symptoms and stress.
Patients must be 18 years of age or older.
Patients must be able to understand and sign a document that explains the study and agree to participate. This is called informed consent.
The doctor must agree that the patient can receive 1 mg of midazolam, a medication used to help with symptoms like anxiety, restlessness, agitation, or trouble sleeping, either under the skin (SC) or directly into a vein (IV).

Who Cannot Join the Study?

Patients with a terminal illness that requires special care to make them comfortable, known as palliative care.
Patients who need a specific medication called parenteral midazolam to help manage symptoms like anxiety, restlessness, agitation, and difficulty breathing.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Aotaistk Ubckxxrhfy Huwffout	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	20.08.2025

Trial locations

Investigated drugs:

Midazolam Hydrochloride

Midazolam Subcutaneous Injection is a form of medication that is given under the skin using a small needle. It is used to help patients feel calm and relaxed, especially when they are very sick and near the end of life. This method of giving the medication is being studied to see how well it works compared to giving it directly into a vein.

Midazolam Intravenous Injection is the same medication as the subcutaneous injection, but it is given directly into a vein. This method is often used to quickly help patients feel calm and relaxed. The study is comparing this method to the subcutaneous injection to understand how the body absorbs the medication differently with each method.

Investigated diseases:

Critical illness

Terminal Illness – A terminal illness is a disease or condition that is expected to lead to the end of life. It often involves severe symptoms that can include anxiety, restlessness, agitation, and difficulty breathing. As the disease progresses, these symptoms may become more pronounced and require management to maintain comfort. The progression can vary widely depending on the underlying condition causing the terminal state. Patients may experience a decline in physical and mental functions as the illness advances. Symptom management is crucial to ensure quality of life during this stage.

Trial ID:

2025-521082-26-00

Protocol code:

AHUS_PAL_25_01

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Midazolam Hydrochloride: Comparing Subcutaneous and Intravenous Use in Adults with Terminal Illness in Palliative Care

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?