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Comparison of Oral 30% Dextrose and IV Midazolam Sedation During MRI in Neonates
NCT02645279Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2015
- Primary completion
- Feb 2016
- Sponsor
- Baskent University
- Modality
- Small Molecules
- Drugs
- sodium potassium magnesium calcium and glucose injection
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 4 trial of sodium potassium magnesium calcium and glucose injection in Procedural sedation (PS) (2 arms), sponsored by Baskent University. Primary endpoint: Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation at 1 year. Status: unknown.
02
Design
2 armsoral 30% glucose
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
IV midazolam
intravenous administration of midazolam 0.1 mg/kg
03
Endpoints
Primary
Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation
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