Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension vs ibuprofen suspension in the treatment of acute pain in children (SAPed).
This research is investigating how fast different ibuprofen medicines relieve acute (sudden) pain in children. Specifically, it's comparing a form called lysin ibuprofen suspension (like ALGIDRIN) with regular ibuprofen suspension (like MOMENTKID or NUROFEN). The main goal is to see if lysin ibuprofen works just as quickly, or even faster, at reducing pain within the first five minutes. Researchers will use special scales, like face charts, to measure how much pain a child feels. They'll also check how well the pain is controlled after 10, 20, and 30 minutes, and keep an eye out for any side effects. This is a "Phase IV" study, meaning it's looking at medicines already approved for use.
At a glance
What is this study about?
Imagine your child has a sudden ache or pain, like from a bumped knee or a cold. We know that medicines like ibuprofen can help, but wouldn't it be great if they worked even faster? This study is trying to find out if a specific type of ibuprofen, called lysin ibuprofen, starts to ease pain more quickly than the standard ibuprofen medicines you might already know, such as Nurofen or MomentKid.
Researchers are particularly interested in the very first few minutes after a child takes the medicine. They want to see if the pain relief kicks in effectively within the first five minutes. To measure pain in children, they use special charts, like the Wong-Baker Faces Pain Scale (where children pick a face that matches how they feel) or a Numerical Rating Scale (where older children rate their pain on a scale). This helps ensure a clear and consistent way to understand how much pain a child is experiencing.
This isn't a study trying out totally new drugs. Instead, it's looking at different forms of ibuprofen that are already available and used for children. It's called a 'Phase IV' study, which means the medicines are already approved and known to be useful. The aim is to get more detailed information about how they perform, especially concerning how fast they act, so that doctors can make the best choices for children in pain.
Key takeaways
- The study compares how fast two types of ibuprofen work for children's sudden pain.
- It's particularly focused on pain relief within the first five minutes.
- The medicines are already approved and widely used.
- Pain will be measured using child-friendly scales, like face charts.
- The study aims to improve understanding for better pain relief choices.
- Safety and side effects will be closely monitored by the research team.
Who may be eligible?
This study is open to both boys and girls of all ages who are experiencing sudden (acute) pain. The type of pain isn't specified in detail here, but generally, it refers to pain that has come on recently rather than long-lasting, ongoing pain.
There are no age limits mentioned for joining, meaning that children of any age, from very young up to teenagers, could potentially take part. This wide age range suggests the study aims to understand how these medicines work across different childhood stages.
If you're considering this study for your child, the research team will need to check other health details to make sure it's safe and appropriate for them to participate. They’ll discuss your child's full medical history to confirm they meet all the specific requirements.
- Is my child experiencing acute (sudden) pain?
- Is my child currently healthy enough to take ibuprofen?
- Is my child able to communicate their pain level (even with pictures)?
- Am I comfortable with my child receiving either lysin ibuprofen or standard ibuprofen without knowing which one?
- Does my child have any known allergies to ibuprofen or similar medicines?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they will be given one of the ibuprofen medicines (either lysin ibuprofen or standard ibuprofen) for their acute pain. The study is "single-blind," which means your child won't know which specific medicine they are receiving, but the study team will. Doctors and nurses will then regularly ask about your child's pain level using special scales, particularly in the first few minutes (at five, ten, twenty, and thirty minutes) after they've taken the medicine.
They will also monitor your child closely for any side effects or unexpected reactions to the medication. The study focuses on this short period of immediate pain relief. There aren't details about long-term follow-up or multiple visits; the primary assessments happen soon after the medicine is given. The total duration of active participation for your child would likely be quite short, mainly focused around the time the medicine starts working.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What kind of pain is this study for?
This study is for children with 'acute pain,' which means pain that has started suddenly or recently, rather than long-term pain.
Are the medicines in the study new or experimental?
No, both types of ibuprofen medicines in this study are already approved and commonly used for children. This study is learning more about how quickly they work.
Will my child know which medicine they are taking?
No, the study is 'single-blind,' meaning your child won't know if they are receiving lysin ibuprofen or regular ibuprofen. This helps ensure fair results.
How will my child's pain be measured?
Doctors and nurses will use special charts like the Wong-Baker Faces Pain Scale (where children pick a face) or a number scale to understand how much pain your child feels.
What if we change our minds about participating?
You are free to withdraw your child from the study at any time, for any reason, and it will not affect their medical care.
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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