Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients

This study is testing a medicine called amisulpride to prevent children from feeling sick or throwing up after surgery. This common problem, known as post-operative nausea and vomiting (PONV), can be very unpleasant. Researchers want to see if amisulpride is better than or as good as other medicines like dexamethasone and ondansetron that are often used for this. They are looking at how many children don't feel sick or throw up at all for 24 hours after their operation, and also if they need extra medicine for sickness. The study will also check if the medicine is safe and if there are any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Acacia Pharma Limited

Enrolment target

200

Start

14 Jan 2025

post-operative nausea and vomiting in pediatric patients

What is this study about?

When children have an operation, it's quite common for them to feel sick or actually be sick afterwards. This can be very unpleasant and distressing, both for the child and their parents. Doctors call this post-operative nausea and vomiting (PONV). This study is looking into a new use for a medicine called amisulpride, to see if it can help prevent these symptoms in children after surgery.

The study aims to find out if amisulpride works better or as well as other medicines that are currently used to prevent sickness after operations, such as dexamethasone and ondansetron. The main thing they're looking for is whether children have a 'complete response' – meaning they don't feel sick, aren't sick, and don't need any extra medicine for sickness in the first 24 hours after their surgery. They'll also be checking how often children get sick, how bad any sickness is, and when it happens.

Along with how well the medicine works, the study will carefully check for any side effects or problems that might happen. Safety is always a top priority in medical research, especially when it involves children. By doing this study, researchers hope to find better ways to make recovery from surgery more comfortable for young patients.

Key takeaways

A study to find new ways to stop children feeling sick after operations.
Testing amisulpride against standard anti-sickness medicines.
Looking for a 'complete response' – no sickness or extra anti-sickness medicine needed.
Carefully checking for both effectiveness and safety.
Participation lasts 24 hours after surgery, within the hospital stay.

Who may be eligible?

This study is open to both boys and girls of all ages who are having an operation. The doctors running the study will carefully check each child's health to make sure it's safe for them to take part.

There might be some specific reasons why a child couldn't join the study, even if they fit the general age and sex criteria. These reasons are usually to do with existing health conditions or other medicines they might be taking, which could affect the results or make the study medicine unsafe for them.

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.

Is my child having an operation?
Does my child meet the general age requirements?
Is my child a boy or a girl? (Both can join.)
Does my child have any significant health conditions or take medicines that might affect their participation? (You'll need to discuss this with the study team.)

Answer every question to see your result.

What does participation involve?

If a child takes part in this study, they will receive one of the study medicines (amisulpride, dexamethasone, or ondansetron) through a drip into their vein during their operation. For 24 hours after surgery, the healthcare team will closely monitor them to see if they experience any sickness or need other medicines for it. They will also look out for any side effects and take blood samples to check how the medicine is working in their body. There are no additional visits required beyond the child's hospital stay for their operation. The total duration of active participation is the 24 hours immediately following surgery.

Potential risks and benefits

Taking part in this study might offer the potential benefit of a new medicine that could help prevent sickness after surgery, making recovery more comfortable. However, as with any medicine, there's always a possibility of side effects, which the study will carefully monitor. You will be given full details of any known risks. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Germany

Common questions

What is post-operative nausea and vomiting (PONV)?

It's when children feel sick or throw up after having an operation, which is a common problem.

What medicines are being tested?

The study is comparing a new medicine called amisulpride with two commonly used medicines, dexamethasone and ondansetron.

How will we know if the medicine works?

Doctors will check if your child doesn't feel sick, isn't sick, and doesn't need extra medicines for sickness in the 24 hours after their operation.

Will my child know if they are getting the new medicine?

No, this is a 'blind' study, meaning neither you, your child, nor the doctors will know which medicine your child receives until after the study is over.

How long does participation in the study last?

Your child will be monitored for 24 hours after their operation for this study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.