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

NCT04746079 | Unknown DMC

• 1 other identifier: 20-025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; Emergence Delirium

Keywords

ketamine

Outcome Measures

Primary Outcomes (2)

• 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.

  From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.

• 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.

  From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.

Study Arms (2)

Positive Imagery Therapy

EXPERIMENTAL

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\*\*

Behavioral: Positive Imagery Therapy

Control

NO INTERVENTION

Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.

Interventions

Positive Imagery Therapy BEHAVIORAL

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

Positive Imagery Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age below 18 years of age
• any patient with a contraindication to the use of ketamine for the procedural sedation
• any prisoners
• pregnant females

Sponsors & Collaborators

• Mercy Health Ohio: lead
• Lake Erie College of Osteopathic Medicine: collaborator

Study Sites (1)

Mercy Health St Elizabeth Youngstown

Youngstown, Ohio, 44504, United States

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Todd Bolotin, MD

  Bon Secours Mercy Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Bolotin, MD

CONTACT

(330) 219-3838; tbolotin@gmail.com

Kayla Prokopakis, DO

CONTACT

(740) 512-8498; kprokopakis32@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sealed envelope method.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: February 5, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)