NCT04652661

Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Dexmedetomidine
• Midazolam
• MRI
• Pediatrics

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	30 children will be sedated with 2 μg/kg intranasal DEX.
DRUG	Midazolam	30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Timeline

• Start date: 2020-12-10
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2020-12-03
• Last updated: 2023-04-20

Locations

1 site across 1 country: Egypt