Combined Ketamine/Propofol for Emergency Department Procedural Sedation
Status:
Terminated
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
Introduction
Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA)
in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics,
barbiturates, and others, but propofol has gained popularity despite its potential to cause
cardiac and respiratory depression. Obviously the optimal agent or combination of agents has
not been identified. There are reasons to believe that a combination of ketamine and propofol
may have advantages over other agents/combinations. These include better hemodynamic
stability at equal depth of anesthesia with a combination of ketamine/propofol than with
propofol alone, less respiratory depression with the combination in comparison to propofol
alone, and preservation of respiratory drive with the combination. There is one study of
ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the
safety and effectiveness of the combination, but did not compare it to any other agents or
combinations. The investigators designed a randomized, placebo controlled study to compare
propofol to propofol and ketamine for adequacy of sedation and respiratory depression in
Emergency Department procedural sedation and analgesia. The investigators hypothesis was that
the combination of propofol/ketamine would produce better sedation and/or less respiratory
depression than propofol alone.
Methods
Study design
The investigators conducted a randomized, prospective, double-blinded study of all patients
receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed
university teaching hospital. The study was approved by the University of Missouri's
Institutional Review Board and informed consent was obtained from all participants.