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A Study of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-Invasive Radiological Procedures

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 healthy children who need sedation for non-invasive imaging procedures. Sedation means using medication to help children stay calm and still during medical tests. The medication being tested is dexmedetomidine, which will be given through the nose rather than through an injection. This medicine is normally given through a vein, but this study will examine whether giving it through the nose can work well for children who need imaging tests such as scans. The children in this study will be between 6 months and 12 years old and weigh less than 30 kilograms.

The purpose of the study is to find out how well intranasal dexmedetomidine works for sedating children during imaging procedures. The study will look at whether one dose of the medication is enough to provide adequate sedation, or whether some children need a second dose. The researchers will measure how quickly the sedation begins after giving the medication and how long the sedation lasts. They will also track how long the imaging procedure takes, how long children wait before the procedure starts, and how long the total hospital visit lasts.

During the study, the medication will be given through the nose before the imaging procedure begins. The medical team will watch the children carefully to see how well the sedation works and to check for any unwanted effects. The study will also record any side effects that occur. All children participating will receive the active medication, as this study does not include a placebo group. The information gathered will help doctors understand whether this method of giving dexmedetomidine is a good option for sedating children during imaging procedures.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive dexmedetomidine through your nose. This medication is used to help you relax and stay still during the scan.

    The medication will be given as drops or spray into your nostrils. This is called intranasal administration.

    The dose will be calculated based on your body weight.

  2. Step 2

    Waiting period for medication to take effect

    After receiving the medication, you will wait for it to start working.

    The medical staff will observe you during this time to check when you become relaxed enough for the procedure.

    The time it takes for the medication to work will be recorded in minutes.

  3. Step 3

    Assessment of sedation level

    The medical staff will check if you are relaxed enough to proceed with the imaging procedure.

    If the first dose of medication has worked well, you will move forward to the imaging procedure.

    If you are not relaxed enough, you may receive an additional dose of dexmedetomidine through your nose.

  4. Step 4

    Imaging procedure

    Once you are adequately relaxed, the imaging procedure will be performed.

    This is a non-invasive radiological procedure, which means no needles or instruments will enter your body during the scan.

    The duration of the procedure will be recorded in minutes.

  5. Step 5

    Recovery and monitoring

    After the imaging procedure is completed, you will be monitored until the effects of the medication wear off.

    The medical staff will observe you for any side effects from the medication.

    The total time you spend at the hospital will be recorded in minutes.

  6. Step 6

    End of study participation

    Once you have recovered from the sedation and the medical staff confirms you are well, your participation in this study will be complete.

    Information about the effectiveness of the medication and any side effects will be recorded for research purposes.

Who can join the trial?

4 criteria

  • The child must be between 6 months and 12 years old
  • The child must weigh less than 30 kilograms
  • The child needs to have a radiological procedure, which means a medical imaging test such as an MRI or CT scan that does not require surgery or cutting into the body
  • The child must be classified as ASA I or II, which means they are either completely healthy or have mild health problems that are well controlled and do not limit daily activities

Who cannot join the trial?

11 criteria

  • Children who are not healthy cannot participate in this study
  • Children with existing medical conditions that require ongoing treatment are excluded
  • Children who have allergies (bad reactions) to dexmedetomidine (the sedation medicine being tested) cannot take part
  • Children with heart problems or irregular heartbeat cannot participate
  • Children with breathing difficulties or lung disease are not eligible
  • Children with liver problems cannot join the study, as the liver helps break down medicines in the body
  • Children with kidney problems are excluded, as the kidneys help remove medicines from the body
  • Children who are taking certain medications that could interact with the study medicine cannot participate
  • Children with nasal congestion (blocked nose) or nose problems that would prevent the medicine from being given through the nose are not eligible
  • Children who have had a bad reaction to sedation (calming medicine) in the past cannot take part
  • Children with neurological disorders (problems with the brain or nervous system) are excluded
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Investigated drugs

Dexmedetomidine is a sedation medication that will be given through the nose (intranasal) to help children stay calm and still during imaging procedures like scans. This medicine helps children relax without needing injections or intravenous lines, making the experience less stressful for young patients who need to have radiological tests done.

What is already known about the treatment

Dexmedetomidine – Dexmedetomidine is a sedative medication that can be given through the nose (intranasal administration) and is being studied for its ability to safely calm children before non-invasive imaging procedures like MRI or CT scans. This drug works by activating specific receptors in the brain called alpha-2 receptors, which help reduce anxiety and promote sleepiness without significantly affecting breathing. It belongs to a class of medications known as selective alpha-2 adrenergic agonists and is already approved for sedation in intensive care settings, though its use through nasal spray for children undergoing radiology procedures is still being researched to determine how well it works and its safety profile.

Investigated diseases

Sedation in healthy children – This refers to a medically controlled state of reduced awareness and relaxation induced in children who do not have underlying health conditions. The sedation is typically used to help children remain calm and still during medical procedures or examinations. The level of consciousness is deliberately lowered through medication, allowing the child to be less aware of their surroundings while maintaining basic protective reflexes. The effects are temporary and wear off after a period of time once the medication is metabolized by the body. The depth and duration of sedation can vary depending on the medication used and the dose administered. Recovery involves a gradual return to normal alertness and activity levels.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-522778-34-00Estimated enrolment100 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

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