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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01387139
First received: May 20, 2011
Last updated: March 6, 2013
Last verified: November 2012

May 20, 2011
March 6, 2013
January 2011
June 2013   (final data collection date for primary outcome measure)
Frequency of Adverse Events [ Time Frame: From enrollment through completion of follow-up, up to 7 days ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01387139 on ClinicalTrials.gov Archive Site
  • Recovery Time [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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
  • Levels of Ketamine and Propofol in the blood measured in nanograms per milliliter (ml) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Parent satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Physician Performing Procedure Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Nurse Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Recovery Time [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Parent satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Physician Performing Procedure Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Nurse Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
    Measured on a 10-point scale
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Conscious Sedation
  • 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)
  • Active Comparator: Ketamine Alone
    Intervention: Drug: Ketamine
  • Experimental: Ketamine Co-Administered with Propofol
    Intervention: Drug: Ketamine Co-administered with Propofol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
220
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01387139
10-0835
Yes
University of Colorado, Denver
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Principal Investigator: Lalit Bajaj, MD, MPH University of Colorado, Denver
Principal Investigator: Keith Weisz, MD University of Colorado, Denver
University of Colorado, Denver
November 2012

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