Low Dose Ketamine VR Analgesia During Burn Care Procedure

Phase 2

Completed

• Conditions: Burn
• Interventions: Behavioral: Virtual Reality

• 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

Arm && Interventions

Group	Intervention	Description
VR during burn care with Ketamine	Virtual Reality	Comparing Virtual Reality during burn care with Ketamine
VR durin burn care without Ketamine	Virtual Reality	Comparing virtual reality during burn care without Ketamine.

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