Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology
This study is about a pain relief tablet called nefopam, which isn't an opioid. It's already approved for treating sudden pain, like after an operation. However, we don't know much about how the body uses it in people with rheumatic conditions, especially in tablet form. This research aims to understand how nefopam tablets are absorbed, distributed, and removed by the body, which is called pharmacokinetics. By doing this, we hope to make sure that nefopam can be used safely and effectively to help people with acute joint and muscle pain due to rheumatic conditions. Participants will be adults aged 18-75 who are in hospital for acute rheumatic pain.
At a glance
What is this study about?
This study is focusing on a pain medication called nefopam. It's a type of painkiller that isn't an opioid, meaning it works differently from medications like morphine. Nefopam is already used in the UK to help people who have just had surgery or are experiencing other types of sudden, strong pain. Even though it's used, we don't fully understand how it moves through the body, especially when taken as a tablet, and how it really helps people with rheumatic pain.
That's where this study comes in. We want to learn more about how your body handles nefopam tablets – for example, how quickly it gets into your bloodstream, how long it stays there, and how your body gets rid of it. Gathering this information, known as 'pharmacokinetics,' is really important. It helps doctors understand the best way to give the medicine, including what dose to use and how often, to make sure it's as effective as possible while keeping you safe.
The main goal is to improve our knowledge about nefopam tablets for people with sudden (acute) pain related to conditions like arthritis or other rheumatic problems. By getting a clearer picture of how nefopam works inside the body, we can help ensure it's prescribed and used in the best way for patients in the future.
Key takeaways
- This study is about a painkiller called nefopam, used for sudden joint/muscle pain.
- It aims to understand how the body processes nefopam tablets.
- Participants must be in hospital for acute rheumatic pain, aged 18-75.
- Taking part involves receiving nefopam and giving blood samples.
- The study helps improve future pain treatment for rheumatic conditions.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old and currently in hospital because of sudden, strong muscle or joint pain related to a rheumatic condition. We'll also need you to be staying in hospital for at least another four days. Your pain level needs to be at a certain intensity, which we'll measure, and you must understand the study information and agree to take part by signing a form.
If you are a woman who could become pregnant, you'll need to be using reliable contraception for a set period before, during, and after the study. We'll also need to check a pregnancy test. If you've gone through menopause, we'll confirm that. Everyone taking part also needs to be covered by a national health insurance system.
There are also some reasons why you wouldn't be able to join. For example, if you've recently taken nefopam, have serious kidney problems, or have uncontrolled heart disease. Certain other medications you might be taking could also mean you can't participate, so we'll check all your current medicines carefully.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Are you currently in hospital for sudden joint or muscle pain?
- Do you expect to stay in hospital for at least four more days?
- Do you have a pain level that is moderate or severe, as measured by the doctors?
- Have you understood the study information and are willing to sign consent?
- Are you not taking any medications that might interfere with nefopam, or have serious kidney or heart conditions?
What does participation involve?
If you decide to take part, you'll be given nefopam tablets for your pain as prescribed by the study doctors. Throughout your time in the study, which will be while you are still in hospital, we will take several blood samples. These samples will help us understand how the nefopam is moving through your body over time. We will also monitor your pain levels and general well-being. The total duration of your active participation will depend on how long you need to be on the medication and how long we need to collect samples, but it will be within your hospital stay.
Potential risks and benefits
Locations (1)
- CHU de ROUENVerified postcodeRouen, France
Common questions
What is nefopam?
Nefopam is a painkiller that works differently from common opioid medicines. It's used for sudden, strong pain.
Why is this study needed?
The study aims to understand how nefopam tablets work in the body for people with rheumatic pain, so it can be used more effectively and safely.
Will I get the study drug if I join?
Yes, if you meet the criteria, you will receive nefopam tablets as part of your pain treatment during your hospital stay.
How long will I be in the study?
Your participation will be for a portion of your hospital stay, while we monitor how your body handles the medication.
What if I change my mind?
You can leave the study at any time, and it won't affect the medical care you receive.
How to find out more
Sophie Pouplin, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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