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Efficacy and Safety of Transmucosal Midazolam for Proportional Palliative Sedation in Children with Refractory Symptoms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Children who have refractory symptoms—symptoms that cannot be controlled with standard medicines—are the focus of this study. The medication being examined is midazolam, which is given by placing it on the lining of the mouth (transmucosal use). The dose is calculated based on the child’s weight and is adjusted to provide the amount of calm needed, a method called proportional sedation.

The purpose of the study is to describe how well proportional sedation with transmucosal midazolam works and how well it is tolerated in pediatric palliative patients who have refractory symptoms.

Participants will receive the medication as prescribed, with regular observations to see how the symptoms respond and to monitor safety. The study follows each child for a period of time, collecting information on symptom relief and any side effects, before concluding the observation phase.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After joining the study you will be asked to read and sign a consent form that explains the purpose of the research and what is expected from you.
Your legal guardian will also need to provide consent because the study involves children.
Step 2
Baseline assessment
The study team will collect information about your current health, weight, and the symptoms that are not responding to usual treatment.
This information helps determine the appropriate amount of medication and provides a reference point for later comparisons.
Step 3
Medication preparation and dose calculation
You will receive the study medication, which is midazolam formulated for oromucosal (inside the mouth) use.
The dose is calculated as 0.15 mg/kg (milligrams per kilogram of body weight). for example, a child weighing 20 kg would receive 3 mg of the medication.
The exact amount will be prepared by the study staff based on your recorded weight.
Step 4
Administration of the medication
The medication is placed on the mucous membrane in the mouth and allowed to dissolve.
You or your caregiver will be instructed on how to position the dose so it can be absorbed through the mouth lining.
Step 5
Observation and monitoring
After taking the medication, you will be observed for signs of sedation and any side effects.
The study staff will record how well the sedation works and note any reactions such as changes in breathing, heart rate, or comfort level.
This monitoring continues for the period defined by the study protocol, which is tailored to each participant’s needs.
Step 6
Follow‑up assessments
Periodic check‑ins will be scheduled to evaluate the ongoing effectiveness of the sedation and to adjust the dose if necessary.
During each visit, the same information about symptoms and side effects will be collected.
Step 7
Completion of participation
Your involvement in the study will end when the study team determines that the research objectives have been met for you, or if you choose to stop participation.
After completion, you will receive a summary of the observations made during your time in the trial.

Who can join the trial?

10 criteria

Must be younger than 18 years old when the consent form is signed.
If the patient is a girl who could become pregnant, she must agree to use a highly effective birth control method such as pills, patches, injections, implants, an intra‑uterine device, tubal ligation, a partner’s vasectomy, or sexual abstinence.
Must be receiving palliative care (care that focuses on comfort) from a pediatric palliative care team.
Must have a refractory symptom—a symptom that does not get better with usual treatments—of any type.
Must need treatment with midazolam (a medication used for symptom control) for that refractory symptom.
Must not have a usable central venous line (a tube placed in a large vein) or must refuse to use it.
Parents must be able to follow the study steps and collect the required data for the entire study period.
Must be covered by the national health insurance system.
Parents must sign the informed consent form for participation.
Parents must accept that their child could die at home.

Who cannot join the trial?

5 criteria

You have taken midazolam (a medication used for calming) within the last 24 hours; the study requires that you have not used this drug in the past day.
You have already taken part in the earlier SETRAPED study; participants cannot join this study more than once.
You are a female who is currently pregnant or breastfeeding; the study does not include pregnant or nursing mothers.
You have a known problem that makes oromucosal midazolam unsafe, such as an allergy to benzodiazepines (the drug family that includes midazolam) or any ingredient in the medicine, a condition called myasthenia gravis (a disease that causes muscle weakness), severe long‑term breathing problems (chronic respiratory insufficiency), a sleep disorder called sleep apnea syndrome (brief pauses in breathing while asleep), or serious liver disease (severe hepatic impairment).
Your parents cannot read or understand French; the study requires parents who can read and understand French.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centre Hospitalier Regional Universitaire De Tours
Tours, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France

Trial locations

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Investigated drugs

Midazolam is a medication that helps calm patients by slowing down brain activity. In this study, it is given through the mouth’s lining (such as under the tongue) so it works quickly without needing an injection. The drug is being tested to see how well it can provide gentle, adjustable sedation for children who are in palliative care and have symptoms that cannot be controlled by other treatments. Researchers are looking at how effective it is at keeping the child comfortable and how well it is tolerated, meaning they are watching for any side effects or problems while it is used.

Dobutamine Hydrochloride

What is already known about the treatment

Midazolam - Midazolam is given as a meltable tablet that is placed on the inside of the mouth, where it dissolves and is absorbed through the oral mucosa. It is a well‑known medication that is widely used and studied for sedation and anxiety relief in many medical settings. It is mainly used to calm children who have severe, unrelenting symptoms in palliative care, helping them relax without causing deep unconsciousness. Midazolam works by enhancing the activity of a brain chemical called GABA, which slows down nerve signals, and it belongs to the class of drugs known as benzodiazepines, which are short‑acting sedatives.

Investigated diseases

Refractory symptoms in children - Refractory symptoms are signs that do not improve with usual care. In pediatric palliative settings they can include pain, breathlessness, agitation, or seizures. The symptoms tend to remain present and may become more intense as the underlying illness advances. Their persistence can increase discomfort for the child and affect daily activities. Over time they may spread to involve additional body systems, adding to overall distress.