Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-12 @ 3:18 PM
Study NCT ID:
NCT02356705
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2015-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Sponsor:
Jennifer Victory, RN, CCRC
Organization:
Study Overview
Official Title:
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: