Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451724
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2007-03-21
Brief Title:
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Status:
COMPLETED
Status Verified Date:
2010-07
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:
The purpose of this study is to compare how well three different doses of ketamine given as a spray into the nose help to sedate children and help them tolerate repairs of cuts on their faces
Detailed Description:
Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department However administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself Oral medications generally take longer to work and are subject to first-pass metabolism Another alternative is to give the medication by the intranasal route which only requires a spray into the nose Ketamine is a good sedative drug with favorable qualities and is often used intramuscularly or intravenously It has been used intranasally as a pre-induction by anesthetics sedation for CT scans and brief dental procedures but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation We will be comparing three different doses of ketamine applied intranasally using a mucosal atomization device and determining if there are any differences in efficacy of sedation time to onset of sedation duration of sedation caregiver and physician satisfaction and number of adverse events We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device
Study Oversight
Has Oversight DMC:
None
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?:
None