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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Procedural Sedation, Emergence Delirium

Intervention / Treatment
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* Behavioral: Positive Imagery Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The sealed envelope method.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Imagery Therapy<br>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<br>* Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.<br>|
| No Intervention: Control<br>Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine