Techniques to Reduce the Severity and Frequency of Emergent Reactions

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03832309
• Other study ID #: 2017196
• Status: Terminated
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: June 21, 2021

Study information

• Verified date: April 2022
• Source: CHRISTUS Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	CHRISTUS Health	Corpus Christi	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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