Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial - Full Text View

Purpose

The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of propofol and ketamine is equivalent in complications, patient and physician satisfaction, post-procedure pain level, and procedural outcome to propofol sedation alone.

Condition	Intervention
Sedation	Procedure: 1:1 ketamine-propofol mixture sedation Procedure: Propofol Sedation

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Propofol Ketamine

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

airway complications [ Time Frame: within 12 months of study completion ] [ Designated as safety issue: Yes ]
The use of any: Adjunctive airway device (nasopharyngeal airway (NPA)/oropharyngeal airway (OPA), Jaw thrust or other airway maneuver., Use of Bag Valve Mask (BVM) for ventilation and reversal medications (i.e. Narcan).
subclinical respiratory depression [ Time Frame: within 12 months of study completion ] [ Designated as safety issue: Yes ]
subclinical respiratory depression (hypoxemia despite supplemental oxygen noted on pulse-oximetry, loss of End-tidal carbon dioxide concentration in the expired air (ETCO2) waveform for 15 seconds or greater, systolic pressure (SBP) below 80mm Hg, cardiac arrhythmias.)
satisfaction [ Time Frame: within 12 months of study completion ] [ Designated as safety issue: No ]
Following sedation, questionnaires were completed by the sedating physician, any consultant physician, nurse, and patient

Estimated Enrollment:	130
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1:1 ketamine - propofol mixture	Procedure: 1:1 ketamine-propofol mixture sedation Prepare Ketamine and Propofol 10mg/cc of ketamine 10mg/cc of propofol mix 1:1 in 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus. Repeat dose 0.025 - 0.05 every 60-90 seconds as needed to reach and maintain target level of sedation. May round to nearest 0.5-1 cc. Note - 1 cc = 5mg of propofol and 5mg of ketamine Other Name: Ketofol
Active Comparator: propofol propofol	Procedure: Propofol Sedation Prepare Propofol 10mg/cc of propofol 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus over 30 seconds. Repeat dose 0.025 - 0.05 cc/kg every 30-60 seconds as needed to reach and maintain target level of sedation. May round to nearest 0.5 cc Note - 1 cc = 10 mg of propofol Other Name: Propofol

Arms

Assigned Interventions

Active Comparator: 1:1 ketamine - propofol mixture

Procedure: 1:1 ketamine-propofol mixture sedation

Prepare Ketamine and Propofol 10mg/cc of ketamine 10mg/cc of propofol mix 1:1 in 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus. Repeat dose 0.025 - 0.05 every 60-90 seconds as needed to reach and maintain target level of sedation.

May round to nearest 0.5-1 cc. Note - 1 cc = 5mg of propofol and 5mg of ketamine

Other Name: Ketofol

Active Comparator: propofol

propofol

Procedure: Propofol Sedation

Prepare Propofol 10mg/cc of propofol 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus over 30 seconds. Repeat dose 0.025 - 0.05 cc/kg every 30-60 seconds as needed to reach and maintain target level of sedation.

May round to nearest 0.5 cc Note - 1 cc = 10 mg of propofol

Other Name: Propofol

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

English speaking patients eighteen and older who present to the University of Utah Emergency Department and require, in their treating physician's opinion, procedural sedation for a procedure or radiologic study performed in the Emergency Department.

Exclusion Criteria:

Include prior sensitization or allergic reaction to propofol, ketamine, soy or egg products; hemodynamic instability; clinical evidence of head injury, increased intracranial or intraocular pressure; use of drugs known to interact with either study agent, pregnancy with a live intra-uterine pregnancy (i.e. undergoing Dilation and Curettage for intrauterine fetal demise or spontaneous abortion is not an exclusion criteria).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269307

Contacts

Contact: Virgil Davis, MD	8015812417	Virgil.Davis@hsc.utah.edu
Contact: Anas Sawas, MS, MPH	(801) 839-4742	ansawas@hsc.utah.edu

Locations

United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Virgil Davis, MD 801-581-2417 virgil.davis@hsc.utah.edu
Principal Investigator: Virgil Davis, MD

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:	Scott Youngquist, MD MSc	University of Utah
Principal Investigator:	Virgil Davis, MD	University of Utah
Principal Investigator:	Troy Madsen, MD	University of Utah
Principal Investigator:	Anas Sawas, MS MPH	University of Utah
Principal Investigator:	Matthew Ahern, DO	University of Utah
Principal Investigator:	Camille Broadwater-Hollifield, M.P.H.	University of Utah, Division of Emergency Medicine

More Information

Publications:

Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med. 2007 Jan;49(1):15-22. Epub 2006 Sep 25.

Miner JR, Gray RO, Stephens D, Biros MH. Randomized clinical trial of propofol with and without alfentanil for deep procedural sedation in the emergency department. Acad Emerg Med. 2009 Sep;16(9):825-34.

Burton JH, Miner JR, Shipley ER, Strout TD, Becker C, Thode HC Jr. Propofol for emergency department procedural sedation and analgesia: a tale of three centers. Acad Emerg Med. 2006 Jan;13(1):24-30. Epub 2005 Dec 19.

Zed PJ, Abu-Laban RB, Chan WW, Harrison DW. Efficacy, safety and patient satisfaction of propofol for procedural sedation and analgesia in the emergency department: a prospective study. CJEM. 2007 Nov;9(6):421-7.

Friedberg BL. Propofol-ketamine technique: dissociative anesthesia for office surgery (a 5-year review of 1264 cases). Aesthetic Plast Surg. 1999 Jan-Feb;23(1):70-5.

Friedberg BL. Propofol ketamine anesthesia for cosmetic surgery in the office suite. Int Anesthesiol Clin. 2003 Spring;41(2):39-50. Review. No abstract available.

Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. Epub 2008 Aug 27.

Slavik VC, Zed PJ. Combination ketamine and propofol for procedural sedation and analgesia. Pharmacotherapy. 2007 Nov;27(11):1588-98. Review.

Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8.

Willman EV, Andolfatto G. A prospective evaluation of "ketofol" (ketamine/propofol combination) for procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2007 Jan;49(1):23-30. Epub 2006 Oct 23.

Sharieff GQ, Trocinski DR, Kanegaye JT, Fisher B, Harley JR. Ketamine-propofol combination sedation for fracture reduction in the pediatric emergency department. Pediatr Emerg Care. 2007 Dec;23(12):881-4.

Responsible Party:	Virgil Davis, principal investigator, University of Utah
ClinicalTrials.gov Identifier:	NCT01269307 History of Changes
Other Study ID Numbers:	39736
Study First Received:	December 10, 2010
Last Updated:	August 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Anesthesia
Pain
Procedural sedation
Airway/Anesthesia/Analgesia

Additional relevant MeSH terms:

Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Propofol
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 16, 2013