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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    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)
  • Ketamine Co-administered with Propofol (DRUG)
    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)

Condition or Disease

  • Procedural Sedation and Analgesia

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 21 Years
    Enrollment: 183 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2011
    Primary Completion: Jan 01, 2014 ACTUAL
    Completion Date: Nov 03, 2017 ACTUAL
    Study First Posted: Jul 04, 2011 ESTIMATED
    Results First Posted: Feb 17, 2016 ESTIMATED
    Last Updated: Nov 06, 2017

    Sponsors / Collaborators

    Lead Sponsor: University of Colorado, Denver
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Aurora, Colorado, USA

    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.

    Participant Groups

    • 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)

    • 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)

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 21
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.

    • 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

    • Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

    • Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

    • Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

    More Details

    NCT Number: NCT01387139
    Other IDs: 10-0835
    Study URL: https://clinicaltrials.gov/study/NCT01387139
    Last updated: Sep 29, 2023