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Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

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ClinicalTrials.gov Identifier: NCT01387139
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : February 17, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE July 4, 2011
Results First Submitted Date  ICMJE December 3, 2015
Results First Posted Date  ICMJE February 17, 2016
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
Frequency of Adverse Events [ Time Frame: From enrollment through completion of follow-up, up to 7 days ]
We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
  • Recovery Time [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ]
    Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
  • Efficacy of Sedation [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Efficacy is defined as:
    1. The patient does not have unpleasant recall of the procedure.
    2. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation
    3. The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.
    4. The procedure was successful
  • Parent Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
  • Physician Performing Procedure Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
  • Nurse Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
  • Recovery Time [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ]
    Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
  • Efficacy of Sedation [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Efficacy is defined as:
    1. The patient does not have unpleasant recall of the procedure.
    2. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged ED observation
    3. The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.
    4. The procedure was successful
  • Levels of Ketamine and Propofol in the blood measured in nanograms per milliliter (ml) [ Time Frame: Baseline ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: Baseline ]
  • Parent satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ]
    Measured on a 10-point scale
  • Patient Satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ]
    Measured on a 10-point scale
  • Physician Performing Procedure Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Measured on a 10-point scale
  • Nurse Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ]
    Measured on a 10-point scale
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 5 minutes ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 15 minutes ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 30 minutes ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 60 minutes ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 5 minutes ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 15 minutes ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 30 minutes ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 60 minutes ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Official Title  ICMJE Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Brief Summary The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.
Detailed Description

Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.

Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.

Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.

To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Procedural Sedation and Analgesia
Intervention  ICMJE
  • Drug: Ketamine
    1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
  • Drug: Ketamine Co-administered with Propofol
    0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Study Arms  ICMJE
  • Active Comparator: Ketamine Alone
    1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
    Intervention: Drug: Ketamine
  • Experimental: Ketamine Co-Administered with Propofol
    0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
    Intervention: Drug: Ketamine Co-administered with Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
183
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2011)
220
Actual Study Completion Date  ICMJE November 3, 2017
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages > 3 years and < 21 years
  • American Society of Anesthesiologists (ASA) class I or II
  • Fracture or dislocation requiring reduction under procedural sedation with ketamine as deemed by the attending emergency medicine physician
  • Parent/Legal Guardian or Patient (if 18 years of age or older) has already given verbal consent for procedural sedation as part of standard care for their condition

Exclusion Criteria:

  • Hypertension (Blood Pressure > 95th percentile for age)
  • Glaucoma or acute globe injury
  • Increased intracranial pressure or central nervous system mass lesion
  • Porphyria
  • Previous allergic reaction to ketamine
  • Previous allergic reaction to Propofol or its components including soybean oil, glycerol, egg lecithin, and disodium edentate
  • Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic hyperlipemia, or pancreatitis
  • Mitochondrial myopathies or disorders of electron transport
  • Pregnancy
  • Parent, guardian or patient unwilling/unable to provide informed consent/assent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01387139
Other Study ID Numbers  ICMJE 10-0835
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Colorado Clinical & Translational Sciences Institute
Investigators  ICMJE
Principal Investigator: Lalit Bajaj, MD, MPH University of Colorado, Denver
Principal Investigator: Keith Weisz, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP