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

NCT ID: NCT02645279

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Epilepsy; Trauma; Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

oral 30% glucose

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

Group Type: ACTIVE_COMPARATOR

oral 30% glucose

Intervention Type: OTHER

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.

IV midazolam

intravenous administration of midazolam 0.1 mg/kg

Group Type: ACTIVE_COMPARATOR

IV midazolam

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

H. Evren Eker

Ass Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anis Aribogan, Prof

Role: STUDY_CHAIR

Baskent University Department of Anesthesiology

Other Identifiers

KA15/19

Identifier Type: -

Identifier Source: org_study_id