Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT04652661
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2020-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: