Low Dose Ketamine VR Analgesia During Burn Care Procedure

Phase 2

Completed

• Conditions: Burn

• Registration Number: NCT01889537
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 )

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States