An open label, pharmacokinetic and safety study of Combogesic® IV in pediatric patients with acute pain.
This study is testing a medicine called Combogesic® IV, which is given directly into the bloodstream (intravenously). It's designed to help children and young people who are experiencing pain. We want to understand how safe this medicine is and if there are any side effects. We're also looking at how the body processes the medication, like how quickly it works and how long it stays in the system. This type of research helps doctors understand if new treatments are a good option for patients. The study is particularly interested in making sure it's safe for younger patients.
At a glance
What is this study about?
This study is called 'An open label, pharmacokinetic and safety study of Combogesic® IV in pediatric patients with acute pain'. In simple terms, this means we're looking at a new way to treat sudden pain, like after an operation or an injury, in children and young people. The medicine is called Combogesic® IV, and 'IV' means it's given directly into a vein through a drip. Doctors sometimes give medicine this way when someone needs quick pain relief or can't swallow tablets.
The main thing we want to learn from this study is about safety. We'll be carefully watching for any 'side effects' – that's what we call unwanted reactions to a medicine. This helps us understand if the medicine is safe enough to be used more widely. We also want to see how the body uses the medicine. This means we'll check how much medicine gets into the blood, how quickly it starts to work, and how long it stays in the body before it's broken down or leaves the body. This information is really important for doctors to know the right amount of medicine to give and how often.
This study is a 'Phase III' study, which means the medicine has already been tested in smaller groups and shown some promise. This larger study helps us confirm those findings and gather more information about how it works in a broader group of patients. All the information we gather helps us understand if Combogesic® IV can be a good and safe option for children and young people in pain.
Key takeaways
- This study is testing a pain relief medicine called Combogesic® IV.
- It's for children, young people, and adults experiencing sudden pain.
- The main goal is to check how safe the medicine is and if there are any side effects.
- It also looks at how the body uses the medicine.
- Participation involves receiving the medicine by IV drip and close monitoring.
- You can stop taking part at any time without affecting your medical care.
Who may be eligible?
This study is for people of all ages, including children, young people, and adults, who are experiencing sudden or 'acute' pain. Both males and females can take part. The research team will review your medical history and current health carefully to make sure the study is a good fit for you.
They will need to make sure that taking part won't put your health at risk and that the results we get from you will be helpful for the study. For instance, if you have certain health conditions or are taking specific medicines, you might not be able to join. This is routine for all clinical studies to ensure participant safety and the quality of the research.
- I am experiencing sudden or 'acute' pain.
- I am open to receiving medicine through an IV drip.
- I am willing to attend study appointments and undergo health checks.
- I understand I will be closely monitored for any side effects.
- I am comfortable with providing blood samples if needed for the study.
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 would receive the study medicine, Combogesic® IV, as a drip into your vein. Doctors and nurses will watch you very closely while you are receiving the medicine and afterwards. They will be regularly checking your 'vital signs' like your heart rate, blood pressure, and breathing. You might also have blood tests to check how the medicine is affecting your body and to understand how it's being processed.
The research team will also ask you questions about any side effects you might experience and how you are feeling. You might also be asked to keep track of how much other pain medication you take. The total time you would be involved in the study and how many visits you would need will be explained in detail by the study team. They will ensure you understand what's involved from beginning to end, including any follow-up appointments.
Potential risks and benefits
Locations (1)
- —Hungary
Common questions
What is 'acute pain'?
Acute pain is pain that starts suddenly, often because of an injury or an illness, and usually doesn't last for a long time.
What does 'IV' mean?
'IV' stands for intravenous, which means the medicine is given directly into a vein through a drip, usually in your arm.
Will I know if I'm getting the actual medicine?
Yes, this is an 'open label' study, which means everyone taking part will receive Combogesic® IV, and both you and the doctors will know it.
What are 'side effects'?
Side effects are any unwanted or unexpected reactions you might have to a medicine, like feeling dizzy or sick.
How long will I be in the study?
The study team will tell you exactly how long your involvement will be, including any visits and follow-up, during the consent process.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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