A randomised, double-blind, comparative clinical trial of the effectiveness and tolerability of fentanyl in continuous parenteral perfusion versus on-demand bolus of morphine for the treatment of refractory dyspnoea in patients hospitalised for acute dec
This research trial is comparing two medicines, fentanyl and morphine, for treating severe breathlessness (dyspnoea) in patients admitted to hospital because their heart failure has suddenly worsened. We want to find out if giving fentanyl continuously works better and has fewer side effects than giving morphine when needed (on-demand bolus). Both medicines are strong pain relievers, but they are being used here to help ease breathing difficulties. Patients will help us understand how much their breathlessness improves by using simple scales. This study aims to find the best way to help people breathe more comfortably when they are seriously unwell.
At a glance
What is this study about?
This study is investigating the best way to help people who are very breathless when they are in hospital because their heart failure has suddenly become worse. When someone has severe breathlessness, it can be very distressing. Doctors often use medicines like morphine to help, but this study is comparing two different strong pain-relieving medicines: fentanyl and morphine.
We want to see which one is more effective at making patients feel less breathless and which one causes fewer unwanted side effects. Fentanyl will be given continuously, meaning a steady, small dose will be given over time. Morphine will be given ‘on-demand’, which means a dose is given when the patient needs it. Patients will be asked to rate their breathlessness using simple number scales, so we can track how they feel over a few days: at the start, after 24 hours, after 48 hours, and after 72 hours.
The findings from this study will help doctors understand the best way to manage severe breathlessness in these situations, potentially improving how patients feel when they are very unwell in hospital. This is important research because making breathing easier significantly improves a patient's comfort and quality of life during a difficult time.
Key takeaways
- The study aims to find the best way to treat severe breathlessness in hospital.
- It compares two medicines, fentanyl and morphine, given in different ways.
- Your breathlessness will be monitored over 3 days using simple scales.
- Participation involves receiving one of the study medicines and regular checks.
- Both men and women aged 18 and over can take part if they meet criteria.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
The study is specifically for patients who are in hospital because their heart failure has suddenly worsened and they are experiencing severe breathlessness that hasn't been helped by other treatments. Before you can join, the study team will carefully check your medical history and current health to make sure it's safe and appropriate for you.
- Are you 18 years old or older?
- Are you currently in hospital because your heart failure has suddenly worsened?
- Are you experiencing severe breathlessness that hasn't improved with other treatments?
- Are you willing to have your breathlessness monitored for about 3 days?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will stay in the hospital as usual. You will receive either fentanyl as a continuous infusion (a steady drip) or morphine as a dose given when you need it, depending on which group you are randomly assigned to.
Throughout your participation, which will last for about 3 days, you will be asked to rate your breathlessness using simple scales at specific times: when you join, after 24 hours, after 48 hours, and after 72 hours. Medical staff will monitor you closely, just as they would any patient in hospital. There are no extra visits required outside of your hospital stay.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is 'refractory dyspnoea'?
It means severe breathlessness that hasn't gotten better with the usual treatments.
What's the difference between fentanyl and morphine in this study?
Fentanyl will be given as a continuous drip, while morphine will be given when you feel you need it.
How will my breathlessness be measured?
You'll be asked to rate your breathlessness using simple number scales at different times.
Will I know which medicine I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which medicine you're receiving.
How long will I be in the study?
Your participation in the study focusing on the medication will be for about 3 days while you are in hospital.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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