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

Baskent University

Status and phase: Unknown; Phase 4

Conditions: Epilepsy; Trauma; Metabolic Disease

Treatments: Drug: IV midazolam; Other: oral 30% glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT02645279

KA15/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

oral 30% glucose

Active Comparator group

Description:

oral 30% glucose total 200 mg/kg with 0.5-1 mL increments

Treatment:

Other: oral 30% glucose

IV midazolam

Active Comparator group

Description:

intravenous administration of midazolam 0.1 mg/kg

Treatment:

Drug: IV midazolam