AuthorisedTherapeutic confirmatory (Phase III)Interventional

Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care: the PEDIADEX randomized controlled trial

This research is investigating whether a specific medicine called dexmedetomidine, when used as the first choice to help children sleep in the intensive care unit (ICU), can reduce the problem of confusion, also known as delirium. Delirium can make children feel disoriented or agitated. The study compares dexmedetomidine with midazolam, another medicine commonly used for sedation. Researchers will carefully observe how many children experience delirium in each group. They will use a special scoring system to identify and measure delirium. The ultimate aim is to find out if giving dexmedetomidine first can help minimize confusion in very sick children, potentially improving their recovery and overall experience in the ICU.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

266

Start

29 Oct 2025

Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care:

What is this study about?

When children are very unwell and need to stay in an intensive care unit (ICU), they often need medicines to help them relax or sleep. This is called sedation. Sometimes, these medicines or being very sick can lead to a state of confusion called delirium. Delirium can make children feel disoriented, scared, or even see things that aren't there. It's a challenging experience for both the child and their parents, and it can sometimes make recovery longer.

This study is looking at a medicine called dexmedetomidine. It's already used in hospitals, but researchers want to see if using it as the very first medicine for sedation in children in the ICU can help prevent or reduce delirium compared to another common medicine, midazolam. The main goal is to find out if taking dexmedetomidine first means fewer children will suffer from confusion during their time in the ICU.

The research is a 'Phase III' study, which means it's a large, important trial that aims to confirm if a treatment is effective and safe. By comparing these two medicines, doctors hope to find the best way to keep children comfortable and calm in the ICU, while also making sure they recover as well as possible and avoid difficult side effects like confusion.

Key takeaways

The study aims to see if a certain medicine (dexmedetomidine) can reduce confusion (delirium) in children in intensive care.
It compares dexmedetomidine to another common sedative (midazolam).
Participation involves receiving one of the two medicines and careful monitoring.
The main goal is to improve comfort and recovery for very sick children.
This is a large, important study (Phase III) to confirm treatment effectiveness.

Who may be eligible?

This study is open to both boys and girls of any age who are admitted to the intensive care unit and need sedation. Researchers will look at each child's individual health situation to decide if taking part is a good fit.

There are no specific age limits mentioned, meaning very young children through to teenagers could potentially be involved. The doctors will carefully check if the study medicines and procedures are safe and appropriate for your child given their specific medical condition.

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 currently in intensive care?
Does my child need medicine to help them relax or sleep?
Are we comfortable with my child potentially receiving one of two different sedatives for the study?
Am I willing for my child to be closely monitored for confusion and other effects?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, the main involvement will be receiving either dexmedetomidine or midazolam as their sedative medicine. The choice of which medicine your child receives will be made randomly, like flipping a coin. Doctors and nurses will regularly check your child's level of sleepiness and comfort using special scales. They will also carefully watch for any signs of confusion (delirium) every day using another specific scoring system. The study will monitor how much medicine your child needs, how long they are on a breathing machine, how long they stay in the ICU and hospital, and any other medical issues that come up. The duration of participation will depend on how long your child needs to be in intensive care and receive sedation.

Potential risks and benefits

Participating in any study involves careful consideration. Potential benefits might include your child receiving a sedative thought to reduce confusion, which could lead to a smoother recovery in the ICU. However, there's also the chance the study medicine might not work as hoped or could cause side effects. Possible risks of the medicines include changes in blood pressure or heart rate, or other issues like an unplanned removal of breathing tubes, which will all be closely monitored. You have the full right to withdraw your child from the study at any time, for any reason, without affecting their 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
France

Common questions

What is sedation and why do children need it in ICU?

Sedation means giving medicine to help a child relax, feel calm, or sleep. Children in intensive care often need sedation to help them cope with medical procedures, pain, or being on machines like ventilators.

What is delirium?

Delirium is a state of severe confusion. Children with delirium might seem disoriented, restless, very sleepy, or even imagine things. It's a serious medical condition.

What is the difference between dexmedetomidine and midazolam?

Both are medicines used to help children relax and sleep. This study is trying to understand if one of them is better at preventing confusion (delirium) when used as the first sedative in the ICU.

Will my child definitely get the new medicine?

No, your child will be randomly assigned to receive either dexmedetomidine or midazolam. It's like a lottery, so neither you nor the doctors can choose which one they get as part of the study.

How will you know if my child is confused?

Nurses and doctors will use a special checklist and scoring system called the CAPD scale to regularly check for signs of confusion. A score of 9 or higher suggests delirium.