Low Dose Ketamine VR Analgesia During Burn Care Procedure
VRK
Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 1, 2017
August 1, 2017
2.9 years
May 6, 2013
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 )
Study Arms (2)
VR during burn care with Ketamine
EXPERIMENTALComparing Virtual Reality during burn care with Ketamine
VR durin burn care without Ketamine
EXPERIMENTALComparing virtual reality during burn care without Ketamine.
Interventions
The patient will receive virtual reality during a burn care procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harborview Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Patterson, Ph.D.
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD. ABPP, Professor
Study Record Dates
First Submitted
May 6, 2013
First Posted
June 28, 2013
Study Start
July 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 1, 2017
Record last verified: 2017-08