Optimizing Premedication to Prevent Emergence Delirium in Children Undergoing Ambulatory Surgery: A Randomized Controlled Trial of Oral Dexmedetomidine Versus Midazolam

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260330002

Enrollment

Registered

2026-03-30

Start date

2026-04-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence delirium in children aged 1 to 7 years undergoing elective ambulatory surgery under general anesthesia Emergence Delirium, Pediatric, Oral, Dexmedetomidine, Midazolam

Interventions

Oral dexmedetomidine at a dose of 4 mcg/kg administered 30 minutes before anesthesia induction as premedication.,Oral midazolam at a dose of 0.5 mg/kg administered 30 minutes before anesthesia inducti

Experimental Drug,Active Comparator Drug

Oral Dexmedetomidine,Oral Midazolam

Eligibility

Sex/Gender

All

Age

1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 1 to 7 years 2. ASA physical status I to II 3. Undergoing elective ambulatory surgery with an expected operative time of less than 2 hours under general anesthesia 4. Written informed consent obtained from parents or legal guardians

Exclusion criteria

Exclusion criteria: 1. Parents or legal guardians refuse participation or withdraw consent from the study 2. History of allergy or hypersensitivity to the study medications 3. Children with central nervous system disorders, including developmental delay or intellectual disability 4. Patients with anticipated difficult airway or expected difficulty in tracheal intubation

Design outcomes

Primary

Measure	Time frame
Incidence of pediatric anesthesia emergence delirium at 0, 5, 15, 30, 60 minutes after emergence in PACU Pediatric Anesthesia Emergence Delirium (PAED) scale	—

Secondary

Measure	Time frame
Preoperative anxiety 30 minutes after drug administration Modified Yale Preoperative Anxiety Scale (mYPAS),Sedation level 30 minutes after drug administration University of Michigan Sedation Scale (UMSS),Postoperative pain at 0, 5, 15, 30, 60 minutes after emergence in PACU FLACC pain scale,Mask Acceptance At anesthesia induction time Mask Acceptance Score,Severity of pediatric anesthesia emergence delirium at 0, 5, 15, 30, 60 minutes after emergence in PACU Pediatric Anesthesia Emergence Delirium (PAED) Score,Adverse events From premedication until PACU discharge Clinical monitoring and medical record review	—

Measure

Time frame

Preoperative anxiety 30 minutes after drug administration Modified Yale Preoperative Anxiety Scale (mYPAS),Sedation level 30 minutes after drug administration University of Michigan Sedation Scale (UMSS),Postoperative pain at 0, 5, 15, 30, 60 minutes after emergence in PACU FLACC pain scale,Mask Acceptance At anesthesia induction time Mask Acceptance Score,Severity of pediatric anesthesia emergence delirium at 0, 5, 15, 30, 60 minutes after emergence in PACU Pediatric Anesthesia Emergence Delirium (PAED) Score,Adverse events From premedication until PACU discharge Clinical monitoring and medical record review

—

Countries

Thailand

Contacts

Public ContactChatchayapa Rathanasutthajohn

Department of Anesthesiology, Surin Hospital, Thailand

chatchayapa.rat@gmail.com044511757

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026