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

Primary Purpose

Burn

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality

About this trial

This is an interventional health services research trial for Burn focused on measuring Virtual Reality Ketamine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VR during burn care with Ketamine

VR durin burn care without Ketamine

Arm Description

Comparing Virtual Reality during burn care with Ketamine

Comparing virtual reality during burn care without Ketamine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01889537

First Posted

May 6, 2013

Last Updated

August 30, 2017

Sponsor

National Institute of General Medical Sciences (NIGMS)

1. Study Identification

Unique Protocol Identification Number

NCT01889537

Brief Title

Low Dose Ketamine VR Analgesia During Burn Care Procedure

Acronym

VRK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn

Keywords

Virtual Reality Ketamine

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VR during burn care with Ketamine

Arm Type

Experimental

Arm Description

Comparing Virtual Reality during burn care with Ketamine

Arm Title

VR durin burn care without Ketamine

Arm Type

Experimental

Arm Description

Comparing virtual reality during burn care without Ketamine.

Intervention Type

Behavioral

Intervention Name(s)

Virtual Reality

Intervention Description

The patient will receive virtual reality during a burn care procedure

Primary Outcome Measure Information:

Title

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.

Time Frame

1 day (Immediately following burn care )

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R Patterson, Ph.D.

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

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Low Dose Ketamine VR Analgesia During Burn Care Procedure

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