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Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Procedural Sedation

Intervention: Propofol (Drug); 1:1 Propofol/Ketamine (Drug); 4:1 Propofol/Ketamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Minneapolis Medical Research Foundation

Official(s) and/or principal investigator(s):
James R Miner, MD, Principal Investigator, Affiliation: Minneapolis Medical Research Foundation


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Clinical Interventions During Sedation


Secondary outcome:

Respiratory Depression

Procedural Recall


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult patients undergoing procedural sedation for an urgent procedure in the

Emergency Department Exclusion Criteria:

- Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical

status score >2

Locations and Contacts

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
Additional Information

Starting date: November 2010
Last updated: June 15, 2015

Page last updated: August 23, 2015

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