Techniques to Reduce the Severity and Frequency of Emergent Reactions

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

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.

Study Overview

• Status: Terminated
• Conditions: Analgesia
• Intervention / Treatment: Behavioral: Do we speak to them in a way that convinces them to have the dream; Behavioral: Speaking to them as a regualar person

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • CHRISTUS Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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; 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; Behavioral: Speaking to them as a regualar person; 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.
Other: Control Arm; 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; 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; Behavioral: Speaking to them as a regualar person; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHRISTUS Health
• Investigators: Principal Investigator: Paul Crapo, DO, CHRISTUS Health

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2017196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No