Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Tanta University

Status and phase: Completed; Phase 4

Conditions: MRI; Pediatrics; Dexmedetomidine; Midazolam

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04652661

32466/11/20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Midazolam Group

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam