Ketofol vs Propofol for Emergency Department Procedural Sedation and Analgesia

NCT01211158 | Completed Phase 3

• 1 other identifier: gandolfatto
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

When patients come to the Emergency Department with injuries and infections they often need to have painful procedures performed that are essential to allowing them to recover. To accomplish this, doctors often use "procedural sedation". This involves giving medications through an intravenous line in order to relieve the patient's pain and to make them drowsy while the painful procedure is being performed. This allows the medical staff to perform necessary procedures to patients without causing pain and anguish. There are several types of medications and combinations of medications that are used for procedural sedation. Each medication has its advantages and its disadvantages. Consequently, research is necessary to determine which medication or combination of medications is the most effective and the safest. This study will compare the use of one drug (Propofol) versus the use of a combination of Propofol with another drug (Ketamine). Both of these drugs are already used for procedural sedations in the emergency department but it is not known which of them is the best or the safest. The investigators believe that the combination of ketamine and propofol together will work as good or better than propofol alone and be a safer option as well. Propofol is a well known sedative that is used in many emergency departments and the clinical experience with it has been very good because it acts quickly and wears off quickly. However, propofol is not a good pain-killer and it can also cause patients to stop breathing. This is why monitoring a patient's breathing and vital signs is essential for any procedural sedation. It is known that ketamine is a good pain-killer and helps patients to maintain their breathing. Doctors sometimes use ketamine alone for procedural sedation but patients take a very long time to wake up when ketamine only is used. Thus, the investigators think that by combining ketamine with propofol the investigators can perform painful procedures using procedural sedation without causing patients to stop breathing as often as with propofol alone. Also, the ketamine the investigators use will help treat their pain and make them more comfortable. The investigators plan to enroll 284 patients over the course of about one year. The primary outcome of adverse respiratory events, as well as the secondary outcomes will be assessed during the course of the sedation and recovery period, approximately one hour. Quality of life score and pain will be assessed by telephone interview 3 days after the procedure.

Conditions

Emergency Department Procedural Sedation; Fracture Reduction; Abscess Incision and Drainage; Electrical Cardioversion

Keywords

emergency department; procedural sedation; ketofol; ketamine; propofol; conscious sedation

Outcome Measures

Primary Outcomes (1)

• Number and proportion of patients experiencing a respiratory adverse event as described by the Quebec Criteria

  Oxygen desaturation, central apnea, partial upper airway obstruction, complete upper airway obstruction, laryngospasm, clinically apparent pulmonary aspiration.

  1 hour

Secondary Outcomes (12)

• Quality of sedation

  During procedure - average time 5 - 10 minutes

• Sedation complications

  During procedure and recovery period and before discharge - average time 1-2 hours

• Post-procedural patient comfort

  72 hours post sedation

• Hypotension

  During sedation and recovery - average time 30-45 minutes

• Recovery agitation requiring treatment

  During recovery period - average time 30 - 45 minutes

Study Arms (2)

Propofol alone

ACTIVE COMPARATOR

Patients receiving propofol alone.

Drug: Propofol alone

Ketofol

ACTIVE COMPARATOR

0.375 mg/kg each of ketamine and propofol (mixed in the same syringe) as an initial bolus and 0.188 mg/kg each of ketamine and propofol as necessary until reaching deep sedation (Ramsay score = 5 or greater).

Drug: Ketofol

Interventions

Ketofol DRUG

Syringes containing ketofol (mixed propofol-ketamine) will contain propofol 5mg/ml and ketamine 5 mg/ml. Patients will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication. Patients in the propofol-ketamine group will receive 0.375 mg/kg each of ketamine and propofol as an initial bolus and 0.188 mg/kg each of ketamine and propofol as necessary until reaching deep sedation (Ramsay score = 5 or greater).

Also known as: single-syringe ketamine-propofol 1:1 combination

Ketofol

Propofol alone DRUG

Propofol-only syringes will contain propofol 10 mg/ml. Patients in each group will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication (0.75 mg/kg). One minute after the initial dose of sedative, and every minute thereafter, the attending physician will assess the patient's level of sedation using the Ramsay Sedation Scale (RSS). If the attending physician determines the level of sedation to be inadequate (RSS\<5), additional study drug will be administered at a dose of 0.0375 millilitres per kilogram (0.375 mg/kg) every minute until deep sedation is achieved (RSS=5 or greater).

Also known as: Diprivan

Propofol alone

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 14 years or greater
• deemed to require emergency department procedural sedation by the attending physician

You may not qualify if:

• unable to give informed consent
• hemodynamic instability
• pregnancy
• known allergy to either study medication

Sponsors & Collaborators

• Lions Gate Hospital: lead
• Vancouver Coastal Health Research Institute: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Related Publications (8)

• Bhatt M, Kennedy RM, Osmond MH, Krauss B, McAllister JD, Ansermino JM, Evered LM, Roback MG; Consensus Panel on Sedation Research of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN). Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009 Apr;53(4):426-435.e4. doi: 10.1016/j.annemergmed.2008.09.030. Epub 2008 Nov 20.

  PMID: 19026467 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.

  PMID: 18754820 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.2009.00487.x.

  PMID: 19845550 BACKGROUND

• Miner JR. The surgical stress response, preemptive analgesia, and procedural sedation in the emergency department. Acad Emerg Med. 2008 Oct;15(10):955-8. doi: 10.1111/j.1553-2712.2008.00249.x. No abstract available.

  PMID: 18851717 BACKGROUND

• Arora S. Combining ketamine and propofol ("ketofol") for emergency department procedural sedation and analgesia: a review. West J Emerg Med. 2008 Jan;9(1):20-3. No abstract available.

  PMID: 19561698 BACKGROUND

• 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. doi: 10.1097/pec.0b013e31815c9df6.

  PMID: 18091596 BACKGROUND

• Andolfatto G, Willman E. A prospective case series of pediatric procedural sedation and analgesia in the emergency department using single-syringe ketamine-propofol combination (ketofol). Acad Emerg Med. 2010 Feb;17(2):194-201. doi: 10.1111/j.1553-2712.2009.00646.x.

  PMID: 20370749 RESULT

• 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. doi: 10.1016/j.annemergmed.2006.08.002. Epub 2006 Oct 23.

  PMID: 17059854 RESULT

MeSH Terms

Conditions

Emergencies

Interventions

Propofol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gary Andolfatto, MD

  Lions Gate Hospital, University of British Columbia Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Emergency Medicine, University of British Columbia

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

CA (1)