Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-01-01 @ 1:37 AM
Study NCT ID:
NCT04608734
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients
Sponsor:
Nourhan M.Aly
Organization:
Study Overview
Official Title:
Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.
Detailed Description:
Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.
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?: