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Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

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ClinicalTrials.gov Identifier: NCT02645279
Recruitment Status : Unknown
Verified December 2015 by H. Evren Eker, Baskent University.
Recruitment status was:  Active, not recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
H. Evren Eker, 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.

Condition or disease Intervention/treatment Phase
Epilepsy Trauma Metabolic Disease Other: oral 30% glucose Drug: IV midazolam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Study Start Date : January 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016


Arm Intervention/treatment
Active Comparator: oral 30% glucose
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
Other: oral 30% glucose
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.

Active Comparator: IV midazolam
intravenous administration of midazolam 0.1 mg/kg
Drug: IV midazolam
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 Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645279


Sponsors and Collaborators
Baskent University
Investigators
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Study Chair: Anis Aribogan, Prof Baskent University Department of Anesthesiology

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Responsible Party: H. Evren Eker, Ass Prof, Baskent University
ClinicalTrials.gov Identifier: NCT02645279     History of Changes
Other Study ID Numbers: KA15/19
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by H. Evren Eker, Baskent University:
newborn
MRI
oral 30% glucose

Additional relevant MeSH terms:
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Metabolic Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action