Children's Hospital Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT01387139
The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.
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Notify Me3 year–21 year
All sexes
Interventional
Phase 3
Aurora, Colorado, 80045, United States
Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.
Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.
Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.
To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Time frame: From enrollment through completion of follow-up, up to 7 days
We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
Time frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour
Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
Time frame: After procedure is completed, on average less than 1 hour
Efficacy is defined as:
Time frame: After procedure is completed, on average less than 1 hour
Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time frame: After procedure is completed, on average less than 1 hour
Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time frame: After procedure is completed, on average less than 1 hour
Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
University of Colorado, Denver
Other
Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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