Techniques to Reduce the Severity and Frequency of Emergent Reactions

CHRISTUS Health

Status: Terminated

Conditions: Analgesia

Treatments: Behavioral: Do we speak to them in a way that convinces them to have the dream; Behavioral: Speaking to them as a regualar person

Study type: Interventional

Funder types: Other

Identifiers

NCT03832309

2017196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

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

Control Arm

Other group

Description:

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.

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