Techniques to Reduce the Severity and Frequency of Emergent Reactions

Study Overview
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Brief Summary
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The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.

Detailed Description
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The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department. The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A&M medical school, and serves an inner-city population.

Official Title
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Non-Pharmacological Techniques to Reduce the Severity and Frequency of Emergency Reactions After Procedural Sedation and Analgesia in the Emergency Department

Conditions
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Analgesia

Intervention / Treatment
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* Behavioral: Do we speak to them in a way that convinces them to have the dream
* Behavioral: Speaking to them as a regualar person


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Required need for procedural sedation and analgesia Exclusion Criteria: Age< 18 Hypertension Raised Intracranial pressure Major psychological disorders Procedures involving laryngel manipulations History of Laryngeal sapsm History of adverse reactions to ketamine

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be conducted in the emergency department at CHRISTUS Spohn Shoreline hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn and is the only level II trauma center in south Texas. It is a major affiliate of Texas A& M medical school, and serves an inner-city population
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Packet 1: The Physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel no pain, cause them to forget the procedure, and allow them to dream the dream of their choice. | Behavioral: Do we speak to them in a way that convinces them to have the dream<br>* During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug<br>Behavioral: Speaking to them as a regualar person<br>* During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.<br>|
| Other: Control Arm<br>Half of the participants will receive the sedation medication with the usual conversation while the physician is giving the medication to the patient. The other half of the participants will have a more positive conversation, (which is the study intervention), with the physician while being given the medication. Both group's emergence reactions, if any, will be compared to see if the positive conversation reduced the side effect. | Behavioral: Do we speak to them in a way that convinces them to have the dream<br>* During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug<br>Behavioral: Speaking to them as a regualar person<br>* During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-Test | Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test, | 24 months | 
| STAI-6 | To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information. | 24 months |