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Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

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ClinicalTrials.gov Identifier: NCT04746079
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : September 23, 2022
Sponsor:
Collaborator:
Lake Erie College of Osteopathic Medicine
Information provided by (Responsible Party):
Mercy Health Ohio

Tracking Information
First Submitted Date  ICMJE February 8, 2021
First Posted Date  ICMJE February 9, 2021
Last Update Posted Date September 23, 2022
Actual Study Start Date  ICMJE February 5, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine [ Time Frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour. ]
    RASS score measured is -5 to +4. A lower score indicates someone is more alert, calm, drowsy indicating the patient has no emergence reaction. Higher score indicates an emergence reaction occurred.
  • Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine [ Time Frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour. ]
    PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
Official Title  ICMJE Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
Brief Summary The purpose of this study is to determine if positive imagery therapy while using ketamine in procedural sedation reduces the number of emergence reactions and impacts pre and post-procedural anxiety.
Detailed Description This is a multi-center, randomized controlled trial looking at if positive imagery therapy while using ketamine during procedural sedation will reduce the number of emergence reactions and impacts pre and post procedural anxiety. After informed consent has been established and the subject is determined to meet eligibility criteria, participants will be randomized into 2 groups. The interventional group will undergo positive imagery therapy during sedation and the control will not. The duration of subject participation will be from the onset of sedation beginning until the patient is recovered.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The sealed envelope method.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Procedural Sedation
  • Emergence Delirium
Intervention  ICMJE Behavioral: Positive Imagery Therapy
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.
Study Arms  ICMJE
  • Experimental: Positive Imagery Therapy

    Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy below:

    "Relax and close your eyes. Take deep breaths in through your nose and out through your mouth as you listen to the sound of my voice. (Three second pause.) I want you to picture yourself lying on a towel on a soft sandy beach. (Three second pause.) You can see a palm trees swaying in the wind beneath a bright blue sky with a few white puffy clouds. (Three second pause.) You can feel the sand between your toes, the warm sunlight on your skin and a cool breeze. (Three second pause) You can smell coconut lotion in the breeze. (Three second pause.) You can hear the sound of waves gently crashing on the beach and seagulls crying in the distance. **End of vignette**

    Intervention: Behavioral: Positive Imagery Therapy
  • No Intervention: Control
    Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • at least 18 years of age
  • requires procedural sedation in the emergency department for whom ketamine is selected by the provider as the medication for procedural sedation

Exclusion Criteria:

  • age below 18 years of age
  • any patient with a contraindication to the use of ketamine for the procedural sedation
  • any prisoners
  • pregnant females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Todd Bolotin, MD (330) 219-3838 tbolotin@gmail.com
Contact: Kayla Prokopakis, DO (740) 512-8498 kprokopakis32@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04746079
Other Study ID Numbers  ICMJE 20-025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mercy Health Ohio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mercy Health Ohio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Lake Erie College of Osteopathic Medicine
Investigators  ICMJE
Principal Investigator: Todd Bolotin, MD Bon Secours Mercy Health
PRS Account Mercy Health Ohio
Verification Date May 2022

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