Sedation onset of IN Dexmedetomidine + Fentanyl VS Dexmedetomidine alone

Comparison of Sedation Onset Following Intranasal Premedication with Dexmedetomidine and Fentanyl VS Dexmedetomidine Alone in Children: A Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250812007

Enrollment

Registered

2025-08-12

Start date

2026-01-05

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

Onset of sedation Parental separation Mask acceptance Dexmedetomidine Fentanyl Intranasal Perioperative anxiety Sedation Parental separation Mask acceptance

Interventions

Dexmedetomidine 1 mcg/kg + Fentanyl 1 mcg/kg administered intranasally ,Dexmedetomidine 1 mcg/kg + NSS 0.02 ml/kg administered intranasally

Experimental Drug,Active Comparator Drug

Dexmedetomidine + Fentanyl,Dexmedetomidine

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. age 1-5 2. ASA physical status I-III 3. undergoing elective surgery

Exclusion criteria

Exclusion criteria: 1. body weight > 20 kg 2. intranasal pathology 3. cardiac arrhythmia 4. congenital cyanotic heart disease 5. current use of local vasoconstrictors 6. refuse to take the premedication in the presence of functioning IV line

Design outcomes

Primary

Measure	Time frame
Onset of sedation Continuously monitored after drug administration 5 point sedation scale	—

Secondary

Measure	Time frame
Mean parental separation score at parental separation (in the OR) 4 point parental separation scale ,Sedation level at parental separation at parental separation (in the OR) 5 point sedation scale ,Parental satisfaction at parental separation (in the OR) 5 point scale ,Mask acceptance score following anesthesia mask introduction (which covered the nose & mouth) 4 point mask acceptance scale ,Sedation level at mask introduction following anesthesia mask introduction 5 point sedation scale,Incidence of bradycardia following drug administration PR ,Incidence of desaturation following drug administration SpO2	—

Measure

Time frame

Mean parental separation score at parental separation (in the OR) 4 point parental separation scale ,Sedation level at parental separation at parental separation (in the OR) 5 point sedation scale ,Parental satisfaction at parental separation (in the OR) 5 point scale ,Mask acceptance score following anesthesia mask introduction (which covered the nose & mouth) 4 point mask acceptance scale ,Sedation level at mask introduction following anesthesia mask introduction 5 point sedation scale,Incidence of bradycardia following drug administration PR ,Incidence of desaturation following drug administration SpO2

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Countries

Thailand

Contacts

Public ContactSaowaphak Lapmahapaisan

Faculty of Medicine Siriraj Hospital, Mahidol University

saowaphak.lap@mahidol.ac.th024197990

Outcome results

None listed

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