dexmedetomidine for Emergence delirium

Inclusion criteria

• {"criterion_text":"- American Society of Anesthesiologists I and II\n- Children aged 1–7 years\n- Scheduled to undergo adenotonsillectomy"}

Exclusion criteria

• {"criterion_text":"- Known allergies or intolerances to Dexmedetomidine\n- Acute cerebrovascular conditions\n- Clinically unfit for general anesthesia\n- 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.\n- Daily use of analgesics\n- Under investigation for a neuropsychiatric diagnosis as defined in exclusion point number 3.\n- Children whose legally authorized representative does not speak and read sufficient Norwegian or English.\n- Missing consent from the participant’s legally authorized representatives\n- Second- or third-degree atrioventricular block, unless the patient has a pacemaker.\n- Uncontrolled hypotension"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"PAEDs score ≥ 10 between waking and 45 minutes after waking; measured at 15, 30 and 45 minutes after waking up (or when signs of ED occur). Recorded dichotomously: ED present if PAEDs ≥ 10, absent otherwise."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Richmond Agitation-Sedation Scale score > 0 measured at 15, 30 and 45 minutes after waking (or when signs occur); dichotomous outcome (present if score > 0)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pain during first 45 minutes after waking measured using FLACC (Face, Legs, Activity, Cry, Consolability), Nurse Numeric Rating Scale, and Parental Numeric Rating Scale."}
• {"endpoint_text":"- Level of pain during the stay in the Post-Anesthesia Care Unit. Measured with total opioid analgesic consumption.","definition_or_measurement_approach":"Pain in PACU measured by total opioid analgesic consumption."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Length of stay during anesthesia and in PACU according to local discharge criteria."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Postoperative nausea and vomiting in PACU and initial 24 hours measured with Baxter Retching Faces scale."}
• {"endpoint_text":"- The parental satisfaction score will be measured with the Pediatric Anesthesia Parent Satisfaction score.","definition_or_measurement_approach":"Parental satisfaction measured with Pediatric Anesthesia Parent Satisfaction score."}
• {"endpoint_text":"- The frequency of adverse events, after investigestional medicinal product administration, in the intervention groups.","definition_or_measurement_approach":"Frequency of adverse events after IMP administration recorded in intervention groups."}
• {"endpoint_text":"- The frequency of systolic blood pressure hypotension, after investigestional medicinal product administration, in the intervention groups.","definition_or_measurement_approach":"Frequency of systolic blood pressure hypotension after IMP administration recorded in intervention groups."}

Norway

Earliest CTIS Part Ii Submission Date

13-04-2026

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

2

Number Of Sites

1

Number Of Participants

255

Primary sponsor

Full Name

Akershus University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway