Back to resultsPositive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
Primary Purpose
Procedural Sedation, Emergence Delirium
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Imagery Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Procedural Sedation focused on measuring ketamine
Eligibility Criteria
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
Sites / Locations
- Mercy Health St Elizabeth YoungstownRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Positive Imagery Therapy
Control
Arm Description
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**
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.
Outcomes
Primary Outcome Measures
Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine
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
PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.
Secondary Outcome Measures
Full Information
NCT ID
NCT04746079
First Posted
February 8, 2021
Last Updated
September 22, 2022
Sponsor
Mercy Health Ohio
Collaborators
Lake Erie College of Osteopathic Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04746079
Brief Title
Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
Official Title
Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Health Ohio
Collaborators
Lake Erie College of Osteopathic Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Sedation, Emergence Delirium
Keywords
ketamine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sealed envelope method.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive Imagery Therapy
Arm Type
Experimental
Arm Description
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**
Arm Title
Control
Arm Type
No Intervention
Arm Description
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.
Intervention Type
Behavioral
Intervention Name(s)
Positive Imagery Therapy
Intervention Description
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.
Primary Outcome Measure Information:
Title
Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine
Description
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.
Time Frame
From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
Title
Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine
Description
PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.
Time Frame
From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Bolotin, MD
Phone
(330) 219-3838
Email
tbolotin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Prokopakis, DO
Phone
(740) 512-8498
Email
kprokopakis32@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Bolotin, MD
Organizational Affiliation
Bon Secours Mercy Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Health St Elizabeth Youngstown
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Bolotin, MD
Phone
330-219-3838
Email
tbolotin@gmail.com
First Name & Middle Initial & Last Name & Degree
Chad Donley, MD
Phone
740-607-6318
Email
chad.donley@alteonhealth.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
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