AuthorisedTherapeutic exploratory (Phase II)Interventional

SETRAPED : A prospective, multicenter study evaluating the efficacy and tolerance of transmucosal midazolam for proportionate palliative sedation in children with refractory symptoms

When children are very unwell and nearing the end of life or dealing with complex illnesses, they can sometimes experience severe symptoms such as pain, agitation, or breathlessness that standard medicines cannot calm. This is known as having refractory symptoms. This study, called SETRAPED, is exploring whether a medicine called midazolam can help. Midazolam is given as a liquid absorbed through the lining of the mouth, meaning children do not need an injection or drip. The aim is to provide 'proportionate sedation', which means calming the child just enough to relieve their distress while keeping them as comfortable as possible. Researchers want to learn how well this medicine works, how safe it is, and whether it improves the quality of care for children and their families during very difficult moments.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Leon Berard

Enrolment target

Start

17 Jul 2026

Children with refractory symptoms

What is this study about?

When children have very serious, life-limiting illnesses, doctors and nurses do everything they can to keep them comfortable. Sometimes, standard treatments are not enough to ease severe pain, distress, or breathlessness. In palliative care, these hard-to-treat problems are called 'refractory symptoms'. When this happens, doctors may use calming medicines to help the child relax and rest comfortably. This gentle approach is known as palliative sedation.

The SETRAPED study is looking at using a medicine called midazolam to provide this relief. Midazolam is a well-known calming medicine, but this study tests giving it 'transmucosally'—which means placing drops or liquid against the inside of the cheek or under the tongue. This allows the medicine to be absorbed quickly into the body without needing needles, injections, or painful drips. The goal is 'proportionate' sedation, meaning doctors give only the exact amount needed to ease the child's distress while avoiding unnecessary deep sleep.

This research matters because finding gentle, needle-free ways to ease severe symptoms can make a huge difference to a child's comfort. It also helps palliative care teams understand the best, safest doses to use, giving families reassurance that their child is receiving peaceful and tailored care.

Key takeaways

The study tests a needle-free calming liquid (midazolam) given inside the cheek.
It aims to soothe severe distress in children receiving palliative care when other treatments have failed.
The goal is gentle, proportionate relief tailored to the child's exact needs.
Children of any age can take part if their care team agrees it is suitable.
Participation is entirely voluntary, and standard compassionate care is always prioritized.

Who may be eligible?

This study is open to children and young people of any age who are receiving palliative care. To be considered, a child must be experiencing severe symptoms—such as intense distress, restlessness, or pain—that have not improved with other standard treatments.

Because every child's medical needs are unique, the palliative care team will carefully check whether this approach is suitable. Children who can already be kept comfortable with their usual medicines will not need to take part.

Both boys and girls can take part. Parents or guardians will be fully involved in the discussion, and the doctors will ensure that taking part is in the child's best interests.

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.

The child is currently receiving specialist palliative or comfort care.
The child has distressing symptoms that standard medicines have not eased.
The child can safely have liquid medicine placed inside their mouth.
The child's family and doctors agree that gentle sedation may help bring comfort.

Answer every question to see your result.

What does participation involve?

If a child takes part in this study, they will receive midazolam as a liquid placed gently inside the mouth, usually against the inside of the cheek. This is done whenever severe symptoms occur that require quick, calming relief.

Because the child is already under the care of a specialist medical team, taking part usually does not mean extra hospital visits or stressful tests. Instead, doctors and nurses will closely watch how the child responds to the medicine. They will check how quickly the medicine works, how peaceful the child feels, and monitor their breathing and heart rate.

The study takes place during the child's regular care. The team will record how well the medicine worked and any side effects over the hours and days following the dose.

Potential risks and benefits

The possible benefit of taking part is that the medicine may quickly ease severe distress or pain without the need for needles or drips. However, there is no guarantee it will work for every child. Like all calming medicines, midazolam can cause side effects, such as making a child sleepier than intended or temporarily slowing their breathing. The medical team will monitor the child very closely to keep them safe. Joining the study is completely voluntary, and parents can choose to withdraw their child at any time without affecting the quality of their care.

Locations (1)

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

—
Unverified
France

Common questions

What does 'transmucosal' mean?

It means the medicine is given as drops or liquid inside the mouth, usually against the inside of the cheek. It absorbs quickly through the lining of the mouth, so no needle or injection is needed.

Will this medicine put my child into a deep sleep?

The goal is 'proportionate' sedation, which means giving just enough medicine to take away distress and bring comfort, rather than putting the child into a deep sleep unless absolutely necessary for their comfort.

Does my child have to travel to take part?

Usually no. This study takes place alongside normal palliative care, whether that is in a hospital, a hospice, or sometimes at home, depending on where the care team is based.

What happens if the medicine does not work?

The care team will step in immediately with other standard medicines and treatments to ensure your child remains as comfortable and pain-free as possible.

Can I change my mind after agreeing to take part?

Yes, absolutely. You can withdraw your consent at any point, and your child's care and treatment will continue with full support from the medical team.