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Effect of Dexmedetomidine vs Sodium Chloride on Emergence Delirium in Children Aged 1‑7 Years Undergoing Adenotonsillectomy

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

The trial looks at children aged 1‑7 who are having adenotonsillectomy, a surgery to remove the adenoids and tonsils to improve breathing. The condition being studied is emergence delirium, a confused and restless state that can happen when a child wakes up from anesthesia. The study will test whether the medication dexmedetomidine can lower the chance of this problem compared with a placebo that contains sodium chloride. The purpose is to see if this drug reduces the risk of emergence delirium in this setting.

Children are randomly assigned to receive either the study drug or the placebo during the operation. The anesthesia team uses heart rate variability and electroencephalography to guide how deep the anesthesia is. After surgery, the child’s behavior is checked at 15, 30 and 45 minutes after waking using the PAEDs score and simple pain scales to see if delirium or pain is present. The length of stay in the recovery area and any side effects are also recorded.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to participate, personal information and medical history are recorded.

    The purpose of the study and possible risks are explained in simple language.

  2. Step 2

    Randomization and receipt of study medication

    The participant is assigned by a computer to receive either dexmedetomidine (the test drug) or sodium chloride (the placebo).

    The assignment is kept unknown to the participant and the medical team.

  3. Step 3

    Administration of medication

    The study medication is given by intranasal spray (through the nose).

    The dose is 4 µg per kilogram of body weight, calculated from the child’s weight.

    Only a single dose is given, shortly before the start of anesthesia.

  4. Step 4

    Induction of general anesthesia

    Standard general anesthesia is started to allow the surgery.

    The depth of anesthesia is guided by heart rate variability and electroencephalography monitoring, which are non‑invasive ways to watch brain activity and heart rhythm.

  5. Step 5

    Surgical procedure

    The child undergoes adenotonsillectomy, the removal of the adenoids and tonsils.

    The surgery is performed while the child is under anesthesia.

  6. Step 6

    Awakening and emergence delirium monitoring

    After surgery, the child is allowed to wake up in the post‑anesthesia care unit.

    At 15, 30 and 45 minutes after waking, the staff checks for emergence delirium using two tools:

    PAED score (a questionnaire where a score of 10 or higher indicates delirium) and the Richmond Agitation‑Sedation Scale (a score above 0 indicates agitation).

  7. Step 7

    Pain assessment

    During the first 45 minutes after waking, pain is measured with three simple scales:

    FLACC (observes face, legs, activity, cry, and consolability), the nurse’s numeric rating scale (0–10), and the parent’s numeric rating scale (0–10).

  8. Step 8

    Monitoring of additional outcomes

    Total use of opioid pain medication is recorded.

    Nausea and vomiting are checked with the Baxter Retching Faces scale.

    Blood pressure is watched for low systolic values, and any adverse events are documented.

  9. Step 9

    Discharge from post‑anesthesia care unit

    The child leaves the care unit when local discharge criteria are met, which include stable breathing, alertness, controlled pain, and no significant nausea or vomiting.

Who can join the trial?

3 criteria

  • Be classified as American Society of Anesthesiologists (ASA) I or II, which means you are healthy or have only mild, well‑controlled health problems.
  • Be a child between 1 and 7 years old.
  • Be scheduled to have an adenotonsillectomy, a surgery that removes the adenoids and tonsils.

Who cannot join the trial?

10 criteria

  • Allergy or intolerance to dexmedetomidine (the medication being studied)
  • Having a recent stroke or brain blood vessel problem
  • Being medically unsuitable for general anesthesia (the sleep‑like state used during surgery)
  • Having certain neuropsychiatric conditions such as intellectual disability, developmental disorders, or emotional/behavior problems that start in childhood (listed as ICD‑10 codes F70‑F98)
  • Using pain‑relief medicines every day
  • Being evaluated for a neuropsychiatric condition that matches the point above
  • Having a parent or guardian who cannot read or speak enough Norwegian or English
  • Missing signed permission from the parent or legal guardian
  • Having a second‑ or third‑degree atrioventricular block (a type of heart rhythm problem) unless the child already has a pacemaker (a device that helps control heart rhythm)
  • Having low blood pressure that is not under control
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Investigated drugs

  • Dexmedetomidine

    is a medication given through the nose that helps keep children calm and comfortable during surgery. In this study it is being tested to see if it can lower the chance of children becoming confused or agitated (called emergence delirium) when they wake up after adenotonsillectomy. It works by gently slowing the brain’s activity and providing pain relief without causing deep sleep.

  • Heart rate variability monitoring

    is a method used during the operation to watch how the child’s heartbeat changes over time. By looking at these tiny variations, doctors can tell how stressed or relaxed the nervous system is, which helps them adjust the amount of anesthesia to keep the child stable and comfortable.

  • Electroencephalography (EEG)-guided anesthesia

    involves placing small sensors on the child’s head to record brain waves while they are under anesthesia. The brain‑wave patterns show how deeply the child is asleep, allowing the anesthesiologist to fine‑tune the medication levels so the child stays safely anesthetized and recovers smoothly.

What is already known about the treatment

  • Dexmedetomidine

    Dexmedetomidine is supplied as a sterile solution for infusion that can be given intranasally, and it is an approved medication widely used in hospitals for sedation and pain control, with many studies describing its effects. It is mainly used to calm patients and to lower the chance of agitation after surgery, such as emergence delirium in children. At the molecular level it activates alpha‑2 adrenergic receptors in the brain, which reduces nerve activity and heart rate, creating a calming effect. It belongs to the pharmacologic class of selective alpha‑2 adrenergic agonists.

  • Sodium chloride

    Sodium chloride is provided as a sterile solution for injection that may be administered intranasally as a placebo, and it is a well‑known, long‑standing medical product used to replace fluids and electrolytes, appearing in countless clinical reports. Its primary purpose is to serve as a simple fluid and electrolyte replacement or as a neutral vehicle in studies. It works by delivering sodium and chloride ions that help keep body fluid balance, without any specific drug action. It is classified as an electrolyte solution and a solvent/diluting agent.

Investigated diseases

Emergence delirium - A temporary disturbance of behavior that appears as a child wakes from anesthesia, marked by confusion, agitation, and crying. It usually begins within a few minutes after awakening and can last up to about 45 minutes. During this time the child may alternate between periods of restlessness and brief calm as consciousness returns. The episode gradually resolves as the child becomes fully alert and oriented.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-524086-24-00Protocol codeDEXPAEDEstimated enrolment255 patientsSponsorAkershus University Hospital

sourced from the EU Clinical Trials Register and site verification

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