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

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What is this study about?

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.

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 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 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 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 surgical procedure

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

the surgery is performed while the child is under anesthesia.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Apdqbqyq Uuvarbfchi Hvtjqtyi	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	01.03.2026

Trial locations

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.

Investigated diseases:

Anaesthetic complication neurological

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 ID:

2025-524086-24-00

Protocol code:

DEXPAED

Trial Phase:

Therapeutic confirmatory (Phase III)

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