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Efficacy and Safety of Intranasal Fentanyl vs Intranasal Dexmedetomidine for Preoperative Sedation in Anxious Children Undergoing Day Surgery, A Non-inferiority Double-blinded Randomized Controlled Trial

Efficacy and Safety of Intranasal Fentanyl vs Intranasal Dexmedetomidine for Preoperative Sedation in Anxious Children Undergoing Day Surgery, A Non-inferiority Double-blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180426002
Enrollment
46
Registered
2018-04-26
Start date
2018-08-27
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

Preoperative anxiety Preoperative anxiety Pediatric Fentanyl Dexmedetomidine

Interventions

Intranasal Dexmedetomidine 2 mcg/kg,Intranasal Fentanyl 2 mcg/kg
Active Comparator Drug,Experimental Drug
Dexmedetomidine,Fentanyl

Sponsors

Siriraj Research Development Fund Managed by Routine to Research : R2R
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 2-5 years old Elective day surgery ASA physical status class 1-2 Initial mYPAS at waiting area ≥ 35 Parental acceptance

Exclusion criteria

Exclusion criteria: Allergy to study drugs Cardiac or renal or liver diseases as co-morbidity Allergic rhinitis, nasal congestion Mental retardation Cannot communicate in Thai

Design outcomes

Primary

MeasureTime frame
Anxiety score at time of induction Modified Yale Preoperative Anxiety Scale (mY-PAS) Thai version

Secondary

MeasureTime frame
Adverse effects after drug administration at 10, 20, 30 minute and at time of induction Nausea and vomiting severity, respiratory rate, heart rate

Countries

Thailand

Contacts

Public ContactPichchaporn Praserdvigai

Mahidol university

ppvigai@gmail.com083 163 0733

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026