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

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

Tracking Information

• First Submitted Date: May 6, 2013
• First Posted Date: June 28, 2013
• Last Update Posted Date: September 1, 2017
• Study Start Date: July 2012
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Dose Ketamine VR Analgesia During Burn Care Procedure
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Burn

Intervention

Behavioral: Virtual Reality

The patient will receive virtual reality during a burn care procedure

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2015): 3
• Original Estimated Enrollment (submitted: June 27, 2013): 100
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01889537
• Other Study ID Numbers: 43329-K
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David R. Patterson, National Institute of General Medical Sciences (NIGMS)
• Study Sponsor: National Institute of General Medical Sciences (NIGMS)
• Collaborators: Not Provided

Investigators

• Principal Investigator: David R Patterson, Ph.D.; University of Washington

• PRS Account: National Institute of General Medical Sciences (NIGMS)
• Verification Date: August 2017