Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
Completed · Phase 4
Conditions studied: Procedural Sedation
In brief
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.
Key facts
- Study ID
- NCT01260662
- Run by
- Hennepin Healthcare Research Institute
- People needed
- 271
- Starts
- 2010-11-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2015-07-14
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department
You may not qualify if…
- Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score >2
Where it is running
- Hennepin County Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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