Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Phase 4
- Conditions
- EpilepsyTraumaMetabolic Disease
- Interventions
- Other: oral 30% glucoseDrug: IV midazolam
- Registration Number
- NCT02645279
- Lead Sponsor
- Baskent University
- Brief Summary
The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.
- Detailed Description
Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- Neonates requiring MR imaging for diagnosis
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Exclusion Criteria
- Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral 30% glucose oral 30% glucose oral 30% glucose total 200 mg/kg with 0.5-1 mL increments IV midazolam IV midazolam intravenous administration of midazolam 0.1 mg/kg
- Primary Outcome Measures
Name Time Method 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 Approximately 1 year
- Secondary Outcome Measures
Name Time Method