NCT00451724

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Laceration

Interventions

Type	Name	Description
DRUG	Intranasal ketamine

Timeline

• Start date: 2007-05-01
• Completion: 2010-02-01
• First posted: 2007-03-23
• Last updated: 2010-07-22

Locations

1 site across 1 country: United States