Procedural Sedation Clinical Trial
Official title:
Randomized Blinded Three Arm Trial of Propofol, 1:1 Combination of Propofol and Ketamine, and 4:1 Combination of Propofol and Ketamine for Procedural Sedation in the Emergency Department
This will be a randomized trial of propofol versus the combination of propofol and ketamine
for procedural sedation for procedures in the Emergency Department (ED). Propofol produces
sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County
Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is
also frequently used in the ED in children and sometimes in adults. It has been proposed
that by combining the two agents, the negative side effects of respiratory depression and
hypotension associated with propofol, and the negative effects of dysphoria and vomiting
associated with ketamine, can be avoided.
In the proposed study, patients seen in the ED who will require procedural sedation for a
painful procedure will be randomized to receive either propofol or propofol and ketamine.
During the procedure, patients will be monitored per the standard of care, including use of
a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample
end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully
completed and the patient has returned to his/her baseline mental status, the patient will
be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure,
memory of the procedure, and overall satisfaction with the procedure.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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