Clinical trial NCT04746079: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Sedation
Emergence Delirium
Keywords: ketamine
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
Collaborators: name: Lake Erie College of Osteopathic Medicine
First posted: 2021-02-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sealed envelope method.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine
timeFrame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
measure: Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine
timeFrame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Mercy Health St Elizabeth Youngstown
state: Ohio
Study officials:
affiliation: Bon Secours Mercy Health
name: Todd Bolotin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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