Techniques to Reduce the Severity and Frequency of Emergent Reactions

NCT03832309 | Terminated

• 1 other identifier: 2017196
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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; Behavioral: Speaking to them as a regualar person

Control Arm

OTHER

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; Behavioral: Speaking to them as a regualar person

Interventions

Do we speak to them in a way that convinces them to have the dream BEHAVIORAL

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

Control Arm; Group 1

Speaking to them as a regualar person BEHAVIORAL

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.

Control Arm; Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• Required need for procedural sedation and analgesia

You may not qualify if:

• Age\< 18
• Hypertension
• Raised Intracranial pressure
• Major psychological disorders
• Procedures involving laryngel manipulations
• History of Laryngeal sapsm History of adverse reactions to ketamine

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Health

Corpus Christi, Texas, 78404, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Crapo, DO

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the consent for the study, the physician will do the following depending on which group the patient has been randomized to: 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 not pain, cause them to forget the procedure, and allow them to dream the dream of their choice. The resident will specifically ask the patient what he or she wants to dream about and the resident will then write the patient's answer on the instruction sheet. Packet #2: They physician will be asked to read a written statement about how the drug they will be given will cause analgesia, amnesia, and may cause hallucinations.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: February 6, 2019
• Study Start: November 21, 2017
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)