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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260662
• Other study ID #: HSR 10-3230
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2010
• Last updated: June 15, 2015
• Start date: November 2010
• Est. completion date: August 2013

Study information

• Verified date: June 2015
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

Drug:
• Propofol
1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
• 1:1 Propofol/Ketamine
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
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

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Interventions During Sedation	Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation	From start of sedation procedure to end of sedation procedure, up to 24 hours	Yes
Primary	Hypoxia	Pulse oximetry	From start of sedation procedure to end of sedation procedure, up to 24 hours	Yes
Secondary	Respiratory Depression	Continuous capnographic monitoring	From start of sedation procedure to end of sedation procedure, up to 24 hours	Yes
Secondary	Procedural Recall	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.	Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.	No