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

Hennepin Healthcare

Status and phase: Completed; Phase 4

Conditions: Procedural Sedation

Treatments: Drug: 1:1 Propofol/Ketamine; Drug: 4:1 Propofol/Ketamine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01260662

HSR 10-3230

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 3 patient groups

Propofol

Active Comparator group

Description:

Deep sedation using propofol

Treatment:

Drug: Propofol

1:1 Propofol/Ketamine

Experimental group

Description:

Propofol and ketamine mixed 1:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation

Treatment:

Drug: 1:1 Propofol/Ketamine

4:1 Propofol/Ketamine

Experimental group

Description:

Propofol and ketamine mixed 4:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation

Treatment:

Drug: 4:1 Propofol/Ketamine