Clinical Trial: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

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 Summary: 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.
Sponsor: Rhode Island Hospital

Current Primary Outcome:

  • Efficacy of sedation (OSBDR) [ Time Frame: 30 minutes ]
  • Time to onset of sedation (Ramsay 6-point Sedation Scale) [ Time Frame: 30 minutes ]


Original Primary Outcome:

  • Efficacy of sedation (OSBDR)
  • Time to onset of sedation (Modified 5-point anxiety score)


Current Secondary Outcome:

  • Duration of sedation [ Time Frame: Up to 1 hour ]
  • Primary caregiver satisfaction [ Time Frame: 24 hours ]
  • Physician satisfaction [ Time Frame: Duration of procedure ]
  • Ketamine bioavailability [ Time Frame: 1 hour ]
  • Abnormalities in cardiopulmonary function [ Time Frame: Until time of discharge ]
  • Administration of supplemental sedative medication [ Time Frame: During time required for procedure ]
  • Prolonged sedation (i.e. > 1 hour) [ Time Frame: Until time of discharge from emergency department ]


Original Secondary Outcome:

  • Duration of sedation
  • Primary caregiver satisfaction
  • Physician satisfaction
  • Ketamine bioavailability
  • Abnormalities in cardiopulmonary function
  • Administration of supplemental sedative medication
  • Prolonged sedation (i.e. > 1 hour)


Information By: Rhode Island Hospital

Dates:
Date Received: March 21, 2007
Date Started: May 2007
Date Completion:
Last Updated: July 21, 2010
Last Verified: July 2010