Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT04586504
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Status:
COMPLETED
Status Verified Date:
2025-07
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:
Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:
Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.
Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.
Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.
Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.
Detailed Description:
Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: