Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
NCT Number: NCT00451724
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.
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Notify Me1 year–7 year
All sexes
Interventional
Phase 2
Providence, Rhode Island, 02903, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 minutes
Time frame: 30 minutes
Time frame: Up to 1 hour
Time frame: 24 hours
Time frame: Duration of procedure
Time frame: 1 hour
Time frame: Until time of discharge
Time frame: During time required for procedure
Time frame: Until time of discharge from emergency department
Rhode Island Hospital
Other
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