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Ketofol vs Propofol for Emergency Department Procedural Sedation and Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01211158
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : November 17, 2011
Sponsor:
Collaborators:
Vancouver Coastal Health Research Institute
University of British Columbia
Information provided by (Responsible Party):
Gary Andolfatto, Lions Gate Hospital

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.


Condition or disease Intervention/treatment Phase
Emergency Department Procedural Sedation Fracture Reduction Abscess Incision and Drainage Electrical Cardioversion Drug: Ketofol Drug: Propofol alone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Trial to Evaluate Ketamine-propofol Combination vs. Propofol Alone for Procedural Sedation and Analgesia in the Emergency Department.
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propofol alone
Patients receiving propofol alone.
Drug: Propofol alone
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).
Other Name: Diprivan

Active Comparator: Ketofol
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
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).
Other Name: single-syringe ketamine-propofol 1:1 combination




Primary Outcome Measures :
  1. Number and proportion of patients experiencing a respiratory adverse event as described by the Quebec Criteria [ Time Frame: 1 hour ]
    Oxygen desaturation, central apnea, partial upper airway obstruction, complete upper airway obstruction, laryngospasm, clinically apparent pulmonary aspiration.


Secondary Outcome Measures :
  1. Quality of sedation [ Time Frame: During procedure - average time 5 - 10 minutes ]
    Number of patients maintaing Ramsay Sedation Score (RSS) of 5 or greater throughout the procedure; Number of patients requiring repeat dosing of medication to maintain RSS 5 or greater.

  2. Sedation complications [ Time Frame: During procedure and recovery period and before discharge - average time 1-2 hours ]
    unplanned reversal agent use, unexpected hospital admission due to sedation

  3. Post-procedural patient comfort [ Time Frame: 72 hours post sedation ]
    SF-8 Quality of Life Survey (QualityMetric Inc., Lincoln, RI) and pain-score assessment (10-point Likert scale).

  4. Hypotension [ Time Frame: During sedation and recovery - average time 30-45 minutes ]
    Number of patients experiencing drop in systolic blood pressure below 90 mmHg and requiring intervention such as intravenous fluid bolus or vasopressors.

  5. Recovery agitation requiring treatment [ Time Frame: During recovery period - average time 30 - 45 minutes ]
    Number of patients requiring intervention (medication or restraint) for recovery agitation

  6. Bradycardia [ Time Frame: During procedure and recovery period - average time 30-45 minutes ]
    Number of patients with heart rate less than 60 beats per minute requiring intervention.

  7. Muscular rigidity [ Time Frame: during procedure - average time 5 - 10 minutes ]
    Number of patient experiencing muscular rigidity interfering with the procedure.

  8. Vomiting [ Time Frame: 1 hour ]
    vomiting or retching during procedure and recovery period

  9. Recovery agitation not requiring treatment [ Time Frame: 1 hour ]
    Patients with apparent recovery agitation but not requiring administration of medication

  10. Induction time [ Time Frame: 1 - 15 min ]
    Time and number of medication doses required to achieve RSS 5 or greater.

  11. Procedural agitation [ Time Frame: 1 - 20 min ]
    as judged by the treating physician - patient combativeness, paradoxical response to medication, reactivity to painful manipulation - interfering with procedure

  12. Sedation Efficacy [ Time Frame: 1 hour ]
    1) Patient does not have unpleasant recall of the procedure; 2) Patient did not experience an adverse event resulting in abandonment of the procedure, a permanent complication, prolonged ED observation, or unplanned admission to hospital; 3) Patient did not actively resist or require physical restraint for completion of the procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211158


Locations
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Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
Lions Gate Hospital
Vancouver Coastal Health Research Institute
University of British Columbia
Investigators
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Principal Investigator: Gary Andolfatto, MD Lions Gate Hospital, University of British Columbia Department of Emergency Medicine
Publications of Results:
Other Publications:

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Responsible Party: Gary Andolfatto, Clinical Assistant Professor, Department of Emergency Medicine, University of British Columbia, Lions Gate Hospital
ClinicalTrials.gov Identifier: NCT01211158    
Other Study ID Numbers: gandolfatto
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011
Keywords provided by Gary Andolfatto, Lions Gate Hospital:
emergency department
procedural sedation
ketofol
ketamine
propofol
conscious sedation
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action