Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date September 1, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
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 ) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine VR Analgesia During Burn Care Procedure
Official Title  ICMJE Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Burn
Intervention  ICMJE Behavioral: Virtual Reality
The patient will receive virtual reality during a burn care procedure
Study Arms  ICMJE
  • Experimental: VR during burn care with Ketamine
    Comparing Virtual Reality during burn care with Ketamine
    Intervention: Behavioral: Virtual Reality
  • Experimental: VR durin burn care without Ketamine
    Comparing virtual reality during burn care without Ketamine.
    Intervention: Behavioral: Virtual Reality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
100
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889537
Other Study ID Numbers  ICMJE 43329-K
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David R. Patterson, National Institute of General Medical Sciences (NIGMS)
Study Sponsor  ICMJE National Institute of General Medical Sciences (NIGMS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R Patterson, Ph.D. University of Washington
PRS Account National Institute of General Medical Sciences (NIGMS)
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP