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

Ketamine

Brief Summary

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.

Intervention / Treatment

Propofol (DRUG)

1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
1:1 Propofol/Ketamine (DRUG)

Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
4:1 Propofol/Ketamine (DRUG)

Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

Condition or Disease

Procedural Sedation

Phase

Phase 4

Study Design

Study type:	INTERVENTIONAL
Status:	Completed
Study results:	No Results Available
Age:	1 Year and older (Child, Adult, Older Adult)
Enrollment:	271 (ACTUAL)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Treatment
Masking QUADRUPLE: Participant Care Provider Investigator Outcomes Assessor

Clinical Trial Dates

Start date:	Nov 01, 2010
Primary Completion:	Aug 01, 2013	ACTUAL
Completion Date:	Aug 01, 2013	ACTUAL
Study First Posted:	Dec 15, 2010	ESTIMATED
Results First Posted:	Apr 29, 2015	ESTIMATED
Last Updated:	Jun 15, 2015

Sponsors / Collaborators

Lead Sponsor: Hennepin Healthcare Research Institute

Lead sponsor is responsible party

Responsible Party: N/A

Location

Minneapolis, Minnesota, USA

Participant Groups

Deep sedation using propofol
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
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

Eligibility Criteria

Sex:	All
Minimum Age:	1
Age Groups:	Child / Adult / Older Adult
Healthy Volunteers:	Yes

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

Primary Outcomes

Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
Pulse oximetry

Secondary Outcomes

Continuous capnographic monitoring
After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.

More Details

NCT Number:	NCT01260662
Other IDs:	HSR 10-3230
Study URL:	https://clinicaltrials.gov/study/NCT01260662

Last updated: Sep 29, 2023