Emergence Delirium, Procedural Sedation
Conditions
Keywords
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.
Interventions
BEHAVIORALPositive Imagery Therapy
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.
Sponsors
Lake Erie College of Osteopathic Medicine
Mercy Health Ohio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The sealed envelope method.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine | 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 | 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. |
Countries
United States
Contacts
Primary ContactTodd Bolotin, MD
Backup ContactKayla Prokopakis, DO
Outcome results
None listed