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Intranasal Dexmedetomidine vs Midazolam for Pediatric Laceration Repair
NCT02168439Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Apr 2015
- Countries
- 1
- Sponsor
- University of Pittsburgh
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- anxiety disorder
01
Overview
Phase 4, randomised, double-blind trial of dexmedetomidine in anxiety disorder (2 arms), sponsored by University of Pittsburgh. Primary endpoint: Modified Yale Preoperative Anxiety Scale at Day 1. Started Jun 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dexmedetomidine
Intranasal Dexmedetomidine 2 mcg/kg
Midazolam
Intranasal Midazolam 0.4 mg/kg
03
Who it enrols
Pediatric patients presenting to the Emergency Department with lacerations <5 cm requiring simple suture repair. Excludes patients with allergies to study drugs or those requiring complex repair.
04
Endpoints
Primary
Modified Yale Preoperative Anxiety Scale
Secondary
Visual Analog Scale
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