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

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ClinicalTrials.gov Identifier: NCT01889537
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
David R. Patterson, National Institute of General Medical Sciences (NIGMS)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burn Behavioral: Virtual Reality Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
Study Start Date : July 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Ketamine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 1 day (Immediately following burn care ) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889537


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: David R Patterson, Ph.D. University of Washington
More Information
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Responsible Party: David R. Patterson, PhD. ABPP, Professor, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT01889537    
Other Study ID Numbers: 43329-K
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by David R. Patterson, National Institute of General Medical Sciences (NIGMS):
Virtual Reality Ketamine
Additional relevant MeSH terms:
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Burns
Wounds and Injuries