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Study of dexmedetomidine compared to midazolam to reduce delirium in critically ill children on breathing machines in intensive care

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study involves children who are critically ill and need to be on a breathing machine in a pediatric intensive care unit. The study focuses on a condition called delirium, which is a state of confusion and changes in thinking that can happen to children who are very sick and receiving intensive care. The study will compare two different medications used for sedation, which means keeping children calm and comfortable while they are on the breathing machine. One medication is dexmedetomidine, which will be given as a continuous infusion through a vein. The other medication is midazolam, which belongs to a group of medicines called benzodiazepines and is also given through a vein. The purpose of the study is to find out if using dexmedetomidine can reduce the number of children who develop delirium while they are in the pediatric intensive care unit.

Children in the study will be between one month and seventeen and a half years old and will need to be on a breathing machine for more than twelve hours. They will receive one of the two sedation medications as their main treatment to keep them comfortable. Throughout their stay in the intensive care unit, doctors and nurses will regularly check for signs of delirium using a special rating scale. They will also monitor how well the sedation is working, whether the child is too sleepy or not sleepy enough, and any side effects that might occur. The study will track how long children need to stay on the breathing machine, how long they stay in the intensive care unit, and how long they remain in the hospital overall.

The study will also look at other important outcomes, including how much sedation and pain medication each child needs, whether children experience withdrawal symptoms when medications are stopped, and whether any complications occur such as low blood pressure, slow heart rate, or accidental removal of breathing tubes or other medical devices. Doctors will record if children need additional medications to treat delirium, if they need brain imaging or special tests to check brain activity, and whether they need to be put back on the breathing machine after it is removed. The study will continue to follow children for three months to understand the full impact of the different sedation approaches on their recovery and the costs of their care.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial sedation treatment assignment

    Upon joining the study, the child will be assigned to receive one of two sedation medications through intravenous infusion, which means the medication will be delivered directly into a vein through a continuous drip.

    The child will receive either dexmedetomidine or midazolam as the main sedation medication. Dexmedetomidine is given at a concentration of 100 micrograms per milliliter, while midazolam is given at a concentration of 1 milligram per milliliter.

    At the time of entering the study, the child should have been receiving sedation with benzodiazepines for less than 6 hours.

  2. Step 2

    Continuous sedation monitoring

    Throughout the stay in the pediatric intensive care unit, the child's sedation level will be assessed every 4 hours using the COMFORT B scale, which is a measurement tool that helps determine if the sedation level is appropriate.

    The medical team will monitor whether the child is receiving the correct amount of sedation, ensuring the child is neither too deeply sedated nor insufficiently sedated.

  3. Step 3

    Delirium assessment

    Delirium is a state of confusion that can occur in critically ill children. The child will be regularly evaluated for delirium using the CAPD scale, which is a specific assessment tool for pediatric delirium.

    A CAPD score of 9 or higher indicates the presence of delirium. The medical team will record any episodes of delirium that occur during the intensive care stay.

    The number of days with delirium symptoms will be documented throughout the treatment period.

  4. Step 4

    Additional medication administration

    If needed, the child may receive additional sedative medications such as benzodiazepines, ketamine, or propofol, as well as opioids for pain management.

    The daily amounts of these medications will be calculated based on the child's weight and recorded.

    If severe delirium occurs, the child may be given antipsychotic drugs to help manage the symptoms.

  5. Step 5

    Mechanical ventilation period

    The child will remain on mechanical ventilation, which is a machine that helps with breathing. This is expected to last for more than 12 hours.

    The total time the child spends on mechanical ventilation will be measured in hours.

    Once the child's condition improves, the breathing tube will be removed in a process called extubation. The medical team will monitor whether the child needs to be placed back on the ventilator after the tube is removed.

  6. Step 6

    Safety monitoring

    Throughout the treatment, the medical team will monitor for potential side effects including hypotension, which is low blood pressure, and bradycardia, which is a slower than normal heart rate.

    The team will also watch for accidental removal of medical equipment, such as the breathing tube or central line, which is a special intravenous catheter.

    If necessary, brain imaging or an electroencephalogram, which is a test that measures electrical activity in the brain, may be performed.

  7. Step 7

    Withdrawal syndrome assessment

    As sedation medications are reduced or stopped, the child will be monitored for iatrogenic withdrawal syndrome, which refers to symptoms that can occur when the body adjusts to decreased medication levels after prolonged use.

    The occurrence and severity of any withdrawal symptoms will be documented.

  8. Step 8

    Intensive care unit stay

    The total length of the child's stay in the pediatric intensive care unit will be recorded in days.

    The medical team will document the child's overall condition and any complications that occur during this period.

  9. Step 9

    Hospital stay after intensive care

    After leaving the intensive care unit, the length of the child's remaining hospital stay will be measured in days.

    The child's recovery progress will continue to be monitored until discharge from the hospital.

  10. Step 10

    Follow-up period

    Information about the child's health status will be collected for up to three months following the initial treatment.

    This follow-up period allows for assessment of longer-term outcomes related to the sedation treatment received during intensive care.

Who can join the trial?

5 criteria

  • The child must be between 1 month and 17 years and 6 months old
  • The child must be covered by or entitled to French social security, which is a type of health insurance in France
  • The child's parent or legal guardian must sign and date an informed consent form, which is a document that explains the study and gives permission for the child to participate. If the parent or guardian cannot be reached in an emergency situation, the child may be included first and consent obtained later when the parent or guardian becomes available
  • The child must be able to follow the requirements of the study
  • The child must have been receiving sedation (medicine to help them sleep or stay calm) with benzodiazepines (a type of calming medicine) for less than 6 hours at the time of joining the study

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria (reasons why a patient cannot participate) have been provided for this clinical trial
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Investigated drugs

Dexmedetomidine is a sedative medication given through a vein to help keep patients calm and relaxed while they are on a breathing machine in the intensive care unit. In this trial, it is being tested to see if it can help prevent or reduce confusion and agitation (called delirium) in critically ill children who need help breathing for more than 12 hours.

What is already known about the treatment

Dexmedetomidine – Dexmedetomidine is a sedative medication given through continuous intravenous infusion, which means it is delivered directly into a vein over an extended period of time. This drug is currently used in intensive care settings and is being studied in clinical trials to determine if it can reduce delirium (a state of confusion and altered awareness) in critically ill children who require breathing support through mechanical ventilation for more than 12 hours. It works at the molecular level by activating specific receptors in the brain and nervous system called alpha-2 adrenergic receptors, which helps produce sedation, reduces anxiety, and provides pain relief without significantly affecting breathing function. Dexmedetomidine belongs to the pharmacological class of selective alpha-2 adrenergic receptor agonists and is particularly valued in pediatric intensive care as a first-line sedation option.

Investigated diseases

Delirium – Delirium is a sudden change in mental state that affects a person's ability to think clearly and be aware of their surroundings. It can cause confusion, difficulty focusing attention, and changes in behavior or emotions. In children who are critically ill and need breathing support through a ventilator, delirium can develop during their stay in the intensive care unit. The condition often appears quickly, sometimes within hours or days of being hospitalized. Symptoms may come and go throughout the day, with periods where the child seems more alert followed by times of increased confusion. Delirium in pediatric intensive care patients can make it harder for them to cooperate with medical care and may affect their recovery process.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521039-35-00Protocol codePEDIADEXEstimated enrolment266 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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