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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

2 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

Midazolam – Midazolam is administered either as a subcutaneous injection (under the skin) or an intravenous injection (into a vein) to help manage symptoms in terminally ill patients, such as anxiety, restlessness, agitation, and difficulty breathing. Currently, it is being studied to compare how well the body absorbs it when given under the skin versus directly into the bloodstream. Midazolam is primarily used in palliative care to provide comfort to patients with severe illnesses. It works by enhancing the effects of a natural chemical in the brain called GABA, which helps to calm the nervous system. This medication is classified as a benzodiazepine, a type of drug known for its calming effects.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521082-26-00Protocol codeAHUS_PAL_25_01Estimated enrolment30 patientsSponsorAkershus University Hospital

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