Techniques to Reduce the Severity and Frequency of Emergent Reactions

Ketamine

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.

Intervention / Treatment

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
  • 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
  • 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.

Condition or Disease

  • Analgesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 38 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    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.

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Nov 21, 2017 ACTUAL
    Primary Completion: Jun 21, 2021 ACTUAL
    Completion Date: Jun 21, 2021 ACTUAL
    Study First Posted: Feb 06, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 05, 2022

    Sponsors / Collaborators

    Lead Sponsor: CHRISTUS Health
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Corpus Christi, Texas, USA

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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,

    • To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.

    More Details

    NCT Number: NCT03832309
    Other IDs: 2017196
    Study URL: https://clinicaltrials.gov/study/NCT03832309
    Last updated: Sep 29, 2023