Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
This study is for children and teenagers under 18 who have long-lasting nerve pain and are being treated with an 8% capsaicin patch. The aim is to understand how effective the treatment is and how well patients tolerate it. If a child's doctor recommends the capsaicin patch and they, along with their parents, agree to take part, their medical information will be recorded. Families will also help by tracking pain levels at home. A team will call every day to check for any side effects until they clear up, usually within 24-72 hours. Children will be checked at the start, and again 1, 3, and 6 months after the patch is applied. The treatment can be repeated up to three times, with three months between each application.
At a glance
What is this study about?
This study is for children and teenagers under 18 years old who have a type of long-lasting pain called neuropathic pain. This is pain that comes from damaged nerves. If their doctors decide that treatment with a special 8% capsaicin patch is suitable for them, they might be invited to join this study. Capsaicin is the natural substance that makes chilli peppers hot, and in this patch, it works to relieve nerve pain.
The main goal of this study is to gather information on how well this treatment works for young people and how they cope with it. The doctors want to find out if the patch helps reduce pain and if there are any side effects. By collecting this information, they hope to learn more about using the capsaicin patch safely and effectively in children and teenagers with ongoing nerve pain.
This is an observational study, which means doctors are simply watching and recording what happens during routine treatment. They aren't trying out a new medicine or changing how the treatment is usually given. They are just collecting real-world information to help improve care for other young people with similar pain conditions in the future.
Key takeaways
- This study looks at children and teens under 18 with specific nerve pain.
- It collects information on how an 8% capsaicin patch works and its side effects.
- Participation involves routine treatment, home pain tracking, and phone calls.
- You'll have follow-up assessments at 1, 3, and 6 months.
- This is an observational study, meaning it doesn't change your medical care.
- Your decision to join is entirely voluntary.
Who may be eligible?
To be able to take part in this study, you need to be under 18 years old and have long-lasting nerve pain that affects a specific area of your body. Importantly, a specialist doctor at a children's pain clinic must have decided that treatment with the 8% capsaicin patch is the right treatment for your pain.
You and your parents or guardians must both agree to take part in the study. If you've already had the capsaicin patch applied to the same painful body area before, or if you're already part of a similar study at a different hospital, you won't be able to join this one.
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 under 18 years old?
- Do you have chronic (long-lasting) nerve pain?
- Has your doctor recommended the 8% capsaicin patch for your pain?
- Have you and your parents agreed to take part?
- Have you not had this patch on the same body area before?
- Are you not in another similar study already?
What does participation involve?
If you decide to take part, the 8% capsaicin patch will be applied in an outpatient clinic by trained nurses, just like regular treatment. After the patch is applied, you or your family will help by keeping a record of your pain levels at home. A member of the study team will also call you every 24 hours to check how you're feeling and if you have any side effects from the patch; these calls will continue until any side effects have settled, which usually happens within a day or two.
You will have check-ups with the study team when you join, and then again one month, three months, and six months after the patch is applied. During these check-ups, your pain will be assessed using tools suitable for your age. If needed, the capsaicin patch treatment can be repeated up to three times in total, with three months passing between each application.
Potential risks and benefits
Locations (20)
- CHU AngersVerified postcodeAngers, France· Not yet recruiting
- CHU BordeauxVerified postcodeBordeaux, France· Recruiting
- CHR Bourg en BresseVerified postcodeBourg-en-Bresse, France· Not yet recruiting
- CHU de BrestVerified postcodeBrest, France· Recruiting
- CHU CaenVerified postcodeCaen, France· Recruiting
- CHU GrenobleVerified postcodeGrenoble, France· Not yet recruiting
- CHU LilleVerified postcodeLille, France· Recruiting
- CHU LimogesVerified postcodeLimoges, France· Not yet recruiting
- CHU MarseilleVerified postcodeMarseille, France· Recruiting
- CHU MontpellierVerified postcodeMontpellier, France· Recruiting
- CHU NancyVerified postcodeNancy, France· Not yet recruiting
- CHU NantesVerified postcodeNantes, France· Recruiting
Common questions
What is neuropathic pain?
Neuropathic pain is a type of long-lasting pain caused by damage to your nerves.
What is an 8% capsaicin patch?
It's a skin patch containing a substance found in chilli peppers, used to help reduce nerve pain.
Will the study change how I'm treated?
No, this study just observes and collects information about your standard capsaicin patch treatment; it doesn't change it.
How long will I be involved in the study?
You'll be followed for up to six months after your treatment starts, with check-ups at 1, 3, and 6 months.
Do I have to take part?
No, taking part is completely your choice, and your decision won't affect your medical care.
How to find out more
Philippe J Le Moine, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.