Low Dose Ketamine VR Analgesia During Burn Care Procedure (VRK)

Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.

The purpose of the research is to see whether a low dose of ketamine, a medication used to reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a form of distraction from pain during a painful burn care procedure.

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Behavioral: Virtual Reality

Detailed Description

This study is conducted in a hospital setting. It is a randomized controlled trial comparing the use of virtual reality distraction (VRD) and standard pain medications to the use of VRD, standard pain medications and a single low dose of ketamine as a means to reduce pain during a painful procedure in patients in the hospital.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 18 years
• Compliant and able to complete questionnaires
• No history of psychiatric disorder
• Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
• Able to communicate verbally
• English-speaking
• IV access already in place

Exclusion Criteria:

• Age less than 18 years
• Not capable of indicating pain intensity
• Not capable of filling out study measures
• Evidence of traumatic brain injury
• History of psychiatric disorder
• Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
• Unable to communicate orally
• Receiving prophylaxis for alcohol or drug withdrawal
• Developmental disability
• Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
• Non-English Speaking
• Extreme susceptibility to motion sickness
• Seizure history
• No IV access already in place

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR during burn care with Ketamine; Comparing Virtual Reality during burn care with Ketamine	Behavioral: Virtual Reality; The patient will receive virtual reality during a burn care procedure
Experimental: VR durin burn care without Ketamine; Comparing virtual reality during burn care without Ketamine.	Behavioral: Virtual Reality; The patient will receive virtual reality during a burn care procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Graphic Rating Scale (GRS) is a questionnaire consists of three subjective pain ratings, one subjective anxiety rating, and one rating of fun using the 0-10.	1 day (Immediately following burn care )

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: David R Patterson, Ph.D., University of Washington

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Virtual Reality Ketamine
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 43329-K