Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Primary Purpose
Epilepsy, Trauma, Metabolic Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
oral 30% glucose
IV midazolam
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring newborn, MRI, oral 30% glucose
Eligibility Criteria
Inclusion Criteria:
- Neonates requiring MR imaging for diagnosis
Exclusion Criteria:
- Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
oral 30% glucose
IV midazolam
Arm Description
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
intravenous administration of midazolam 0.1 mg/kg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02645279
First Posted
December 30, 2015
Last Updated
December 31, 2015
Sponsor
Baskent University
1. Study Identification
Unique Protocol Identification Number
NCT02645279
Brief Title
Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Official Title
Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Trauma, Metabolic Disease
Keywords
newborn, MRI, oral 30% glucose
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral 30% glucose
Arm Type
Active Comparator
Arm Description
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
Arm Title
IV midazolam
Arm Type
Active Comparator
Arm Description
intravenous administration of midazolam 0.1 mg/kg
Intervention Type
Other
Intervention Name(s)
oral 30% glucose
Intervention Description
30% glucose solution was administered orally through a teat. 1 mL 30% glucose solution was added following placement of the teat into the mouth of the newborn. After suckling of 0.5-1 mL glucose solution, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added until the newborn kept motionless or asleep.
Intervention Type
Drug
Intervention Name(s)
IV midazolam
Intervention Description
IV 0.1 mg/kg midazolam was administered.MRI was routinely performed and the newborns who did not keep motionless or asleep and had motion artefacts were sedated with intravenous 0.5 mg/kg propofol.
Primary Outcome Measure Information:
Title
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
Time Frame
Approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neonates requiring MR imaging for diagnosis
Exclusion Criteria:
Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anis Aribogan, Prof
Organizational Affiliation
Baskent University Department of Anesthesiology
Official's Role
Study Chair
12. IPD Sharing Statement
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Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
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