Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2022-01-01

Brief Summary

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An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.

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Detailed Description

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This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.

Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:

Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Conditions

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Dexmedetomidine Midazolam MRI Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes:

Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine Group

30 children will be sedated with 2 μg/kg intranasal dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

30 children will be sedated with 2 μg/kg intranasal DEX.

Midazolam Group

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Interventions

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Dexmedetomidine

30 children will be sedated with 2 μg/kg intranasal DEX.

Intervention Type DRUG

Midazolam

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.

Exclusion Criteria

1. Patient's guardian refusal.
2. Body mass index \>30 kg/m2
3. Known allergy to dexmedetomidine or midazolam.
4. Suspected difficult airway.
5. Upper respiratory tract infection
6. Anatomical structural deformity of the nasal cavity.
7. Severe liver or renal impairment.
8. Severe bradycardia or atrioventricular block above II degree type 2.
9. Administration of digoxin or beta blockers

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No