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
  Purpose

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.


Condition Intervention Phase
Conscious Sedation
Drug: Ketamine
Drug: Ketamine Co-administered with Propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine Alone 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)
Experimental: Ketamine Co-Administered with Propofol 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)

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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387139

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Investigators
Principal Investigator: Lalit Bajaj, MD, MPH University of Colorado, Denver
Principal Investigator: Keith Weisz, MD University of Colorado, Denver
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01387139     History of Changes
Other Study ID Numbers: 10-0835
Study First Received: May 20, 2011
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Ketamine
Propofol
Pediatric Conscious Sedation

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Propofol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 28, 2014