A Randomized Open-Label, Parallel-Group, Phase 2, 2-Arm Study to Investigate the Pharmacokinetic Profiles of Midazolam Subcutaneous Injection Compared with Midazolam Intravenous Injection in Adult Male and Female Terminally Ill Patients
This research is looking at different ways of giving a medicine called midazolam. Midazolam helps people with serious illnesses who are receiving end-of-life care, by easing symptoms like anxiety, restlessness, agitation, and breathing difficulties. The study wants to find out how the body takes in and uses midazolam when it's given as an injection just under the skin compared to an injection directly into a vein. Researchers will measure levels of the medicine in the blood over a short time to understand which method might be more effective and comfortable for patients. This is important to ensure patients get the best possible symptom relief with the fewest side effects.
At a glance
What is this study about?
This clinical study is designed to help us understand the best way to give a medicine called midazolam to people who are very ill and receiving care at the end of their lives. Midazolam is a medicine often used to help ease distressing symptoms like feeling very anxious, restless, agitated, or having difficulty breathing. These symptoms can be very uncomfortable, and midazolam helps to bring relief.
Currently, midazolam can be given in different ways, including directly into a vein (intravenously). This study is exploring another way: injecting it just under the skin (subcutaneously). The main goal is to compare how quickly and effectively the body absorbs and uses the medicine when given in these two different ways. We want to see if one method might be better or more comfortable for patients while still providing good relief from their symptoms.
To do this, researchers will take small blood samples at various times after the medicine is given. This helps them measure how much midazolam is in the blood and how long it stays there. They will also be looking at how comfortable the injection site is, how it affects breathing, oxygen levels, and overall comfort, to ensure the chosen method is safe and effective.
Key takeaways
- The study compares two ways of giving midazolam: under the skin vs. into a vein.
- It aims to improve symptom relief for terminally ill patients.
- Midazolam helps manage anxiety, restlessness, agitation, and breathing issues.
- Participation involves monitoring and blood samples for about 90 minutes.
- You won't know which type of injection you receive.
- Your medical care will not be affected if you choose to withdraw.
Who may be eligible?
To take part in this study, you would need to be an adult (18 years or older) who is receiving end-of-life care for a serious illness. You would also need to be experiencing symptoms such as anxiety, restlessness, agitation, or breathing difficulties, for which your doctor believes midazolam injections would be helpful.
Doctors participating in the study will carefully check if an individual meets all the necessary health requirements. Both men and women are welcome to take part. The healthcare team will discuss your specific situation and answer any questions you have to help you decide if this study is right for you.
- Are you 18 years old or older?
- Are you receiving care for a serious illness at the end of your life?
- Do you experience symptoms like anxiety, restlessness, agitation, or breathing difficulties?
- Has your doctor suggested midazolam injections to help manage these symptoms?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be assigned to receive midazolam either as an injection under your skin or as an injection into a vein. You won't get to choose which method you receive.
Once the medicine is given, a healthcare professional will take several small blood samples from you over a period of about 90 minutes. These samples will help the researchers understand how your body is handling the medicine. During this time, they will also carefully monitor things like your breathing, oxygen levels, and how you are feeling, checking for any discomfort at the injection site. The study involves these observations and blood tests for a total of about 90 minutes after the medicine is given.
Potential risks and benefits
Locations (1)
- —Norway
Common questions
What is midazolam?
Midazolam is a medicine used to help with symptoms like anxiety, restlessness, and breathing difficulties in people who are very ill.
Why is this study important?
This study aims to find the best way to give midazolam injections to make sure patients get good relief from their symptoms as comfortably as possible.
Will I know which injection I'm getting?
No, you won't know if you're getting the injection under the skin or into a vein. This helps research be unbiased.
How long will I be monitored?
You will be monitored for about 90 minutes after the midazolam injection is given, with several checks and blood samples during that time.
Can I stop being part of the study?
Yes, you are free to leave the study at any time, and this will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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