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
Not Applicable
Suspended
- Conditions
- Preoperative anxietyPediatricFentanylDexmedetomidine
- Registration Number
- TCTR20180426002
- Lead Sponsor
- Siriraj Research Development Fund Managed by Routine to Research : R2R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 46
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
Allergy to study drugs
Cardiac or renal or liver diseases as co-morbidity
Allergic rhinitis, nasal congestion
Mental retardation
Cannot communicate in Thai
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety score at time of induction Modified Yale Preoperative Anxiety Scale (mY-PAS) Thai version
- Secondary Outcome Measures
Name Time Method Adverse effects after drug administration at 10, 20, 30 minute and at time of induction Nausea and vomiting severity, respiratory rate, heart rate