Efficacy of Dexmedetomidine on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Double-Blind Randomized Controlled Trial with Heart Rate Variability and Electroencephalography-Guided Anesthesia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Akershus University Hospital

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Akershus University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Efficacy, Therapy

To evaluate if dexmedetomidine reduces the risk of emergence delirium in children aged 1-7 years old undergoing adenotonsillectomy during general anesthesia guided by heart rate variability and electroencephalogram monitoring.

Secondary objectives 6

1. To evaluate if dexmedetomidine affects the risk of emergence delirium, as measured with other scoring systems not validated for emergence delirium.
2. To evaluate if dexmedetomidine affects the level of pain postoperatively, measured with several different scoring systems and with analgesia consumption during the Post-Anesthesia Care Unit period and the initial 24-hour postoperative period.
3. To evaluate if dexmedetomidine influences the length of stay in different time periods of the study.
4. To evaluate if dexmedetomidine influences the level of nausea and vomiting postoperatively and in the initial 24-hour postoperative period.
5. To evaluate if dexmedetomidine influences parental satisfaction when measured with a standardized scoring system.
6. To evaluate if dexmedetomidine influences the frequency of adverse events.

Conditions and MedDRA coding

Emergence delirium

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. American Society of Anesthesiologists I and II
2. Children aged 1–7 years
3. Scheduled to undergo adenotonsillectomy

Exclusion criteria 10

1. Known allergies or intolerances to Dexmedetomidine
2. Clinically unfit for general anesthesia
3. Neuropsychiatric diagnoses that include: intellectual disabilities, disorders of psychological development, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. As defined in ICD-10, F70 to F98.
4. Daily use of analgesics
5. Under investigation for a neuropsychiatric diagnosis as defined in exclusion point number 3.
6. Children whose legally authorized representative does not speak and read sufficient Norwegian or English.
7. Missing consent from the participant’s legally authorized representatives
8. Second- or third-degree atrioventricular block, unless the patient has a pacemaker.
9. Uncontrolled hypotension
10. Acute cerebrovascular conditions

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Emergence delirium (ED), defined as a Pediatric Anesthesia Emergence Delirium (PAEDs) score ≥ 10 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up, or whenever there are signs of ED within this time frame. This is a dichotomous endpoint recorded as "ED present" if PAEDs score ≥ 10 and "absent” otherwise.

Secondary endpoints 8

1. Emergence delirium, defined as a Richmond Agitation-Sedation Scale score > 0 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up or whenever there are signs of emergence delirium within this time frame. This is a dichotomous endpoint recorded as "emergence delirium present" if Richmond Agitation-Sedation Scale score > 0 and "absent” otherwise.
2. Level of pain during the first 45 minutes after waking up will be measured with the Face Legs Activity Cry Consolation score, Nurse Numeric Rating Scale score, and Parental Numeric Rating Scale score.
3. Level of pain during the stay in the Post-Anesthesia Care Unit. Measured with total opioid analgesic consumption.
4. Length of stay during anesthesia and in the Post-Anesthesia Care Unit. Departure from the Post-Anesthesia Care Unit will follow the local discharge criteria.
5. Postoperative nausea and vomiting in the Post-Anesthesia Care Unit and in the initial 24-hour postoperative period will be measured with the Baxter Retching Faces scale.
6. The parental satisfaction score will be measured with the Pediatric Anesthesia Parent Satisfaction score.
7. The frequency of adverse events, after investigestional medicinal product administration, in the intervention groups.
8. The frequency of systolic blood pressure hypotension, after investigestional medicinal product administration, in the intervention groups.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Akershus University Hospital

Sponsor organisation

Akershus University Hospital

Address

Sykehusveien 27

City

Lorenskog

Postcode

1478

Country

Norway

Scientific contact point

Organisation

Akershus University Hospital

Contact name

Department of Anesthesiology and Intensive Care.

Public contact point

Organisation

Akershus University Hospital

Contact name

Department of Anesthesiology and Intensive Care.

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications