AuthorisedTherapeutic exploratory (Phase II)Interventional

The use of intranasal dexmedetomidine for pediatric sedation in non-invasive radiological procedures (CTMS 004321) Assessing the efficacy and safety profile of intranasal dexmedetomidine for procedural sedation in radiological procedures in children with a prospective exploratory interventional monocentric study in a tertiary center in Antwerp (Belgium)

This study is testing a special nose spray called dexmedetomidine to help children relax and stay still during medical scans, such as X-rays, in a hospital in Antwerp, Belgium. Sometimes children find these scans a bit scary or difficult to lie still for, so a medicine is needed to help them. The researchers want to find out how effective this nose spray is in making children calm enough for the procedure. They are also looking closely at its safety and whether it causes any unwanted side effects. This is an early-stage study to understand if this medicine could be a good option for children needing sedation for these types of procedures.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Ziekenhuis Antwerpen

Enrolment target

100

Start

07 Nov 2025

Sedation in healthy children

What is this study about?

Imagine your child needs a medical scan, like an X-ray or a CT scan. Sometimes, it can be hard for young children to lie completely still for these procedures, which is really important for getting clear pictures. This study is looking into a new way to help children feel calm and relaxed during these kinds of scans. They are using a medicine called dexmedetomidine, which is given as a nose spray.

The main goal of this particular study is to see how well this nose spray works to help children relax after just one dose. They are also checking if it's safe and noting any side effects. This is a "Phase II" study, which means it's an early step where researchers are still exploring the best way to use the medicine and confirming its effects.

Researchers are carefully observing how quickly the medicine starts to work, how long its calming effect lasts, and how long the whole procedure and hospital visit take. They are doing this in a hospital in Antwerp, Belgium, and focusing on healthy children who need this kind of help to get through their scans comfortably.

Key takeaways

This study is exploring a nose spray (dexmedetomidine) to help children relax for medical scans.
It aims to find out how well it works and if it's safe for children of all ages.
The medicine is given via a simple nose spray.
Researchers will monitor how quickly it works, how long it lasts, and any side effects.
It could make medical scans less stressful for children.

Who may be eligible?

This study is open to most children who need help relaxing for certain medical scans. It doesn't matter how old your child is – from very young babies to teenagers, all ages are welcome to be considered.

Also, it doesn't matter if your child is a boy or a girl; the study is looking to include both. The important thing is that your child is generally healthy and needs sedation for a scan at the specific hospital where the study is taking place.

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 your child generally healthy?
Does your child need help relaxing to stay still for a medical scan (like an X-ray or CT scan)?
Is your child receiving care at the hospital in Antwerp, Belgium, where this study is happening?
Does your child fit within any age (babies to teens)?
Is your child male or female?

Answer every question to see your result.

What does participation involve?

If your child takes part, they would receive the dexmedetomidine medicine as a nose spray before their scan. Researchers would then closely watch your child to see how well the medicine works and if it helps them relax enough for the procedure. They will also note how quickly the medicine starts to work and how long your child remains calm.

Throughout your child's time in the study, medical staff will be monitoring them for any side effects and their general well-being. This involves keeping track of things like how long the scan takes, how long your child needs to be observed afterwards, and the total time they spend at the hospital for this visit. There aren't special extra visits just for the study; the assessments happen as part of your child’s standard hospital visit for their scan.

Potential risks and benefits

Potential benefits for your child could include a calmer and less stressful experience during their medical scan. They might also help researchers learn more about how to best help children relax for these procedures in the future. As with any medicine, there's always a possibility of side effects. Medical staff will monitor your child closely for any reactions. Remember, taking part in a study is always voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is dexmedetomidine?

It's a medicine used to help people feel calm and relaxed, often used before or during medical procedures. In this study, it's given as a nose spray.

Why is it given as a nose spray?

Giving medicine as a nose spray is often easier and less scary for children than injections.

What kind of scans is this for?

It's for non-invasive radiological procedures, which include scans like X-rays, CT scans, or MRIs where children need to lie still.

What if the first dose doesn't work?

The study also looks at whether an additional dose of the nose spray helps if the first dose isn't quite enough to make your child calm.

Will my child be asleep?

The aim is for your child to be deeply relaxed and calm, which might feel like a light sleep, to help them stay still for the scan.