BurnPhase 2VRKNCT01889537
Low Dose Ketamine VR Analgesia During Burn Care Procedure
A Phase 2 study testing Virtual Reality in people with Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Burn
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
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.
Read the 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.
- Conditions
- Burn
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality Ketamine
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
The patient will receive virtual reality during a burn care procedure
| Study group | Role | What they receive |
|---|---|---|
| VR during burn care with Ketamine | Experimental | Comparing Virtual Reality during burn care with Ketamine Receives: Behavioral: Virtual Reality |
| VR durin burn care without Ketamine | Experimental | Comparing virtual reality during burn care without Ketamine. Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (Immediately following burn care )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, David R. Patterson, National Institute of General Medical Sciences (NIGMS)
- Investigators
- David R Patterson, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889537
- Sponsor's protocol ID
- 43329-K
- Acronym
- VRK
- Status last verified
- Aug 2017
- First submitted
- 6 May 2013
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
- ClinicalTrials.gov ID
- NCT01889537
- Acronym / sponsor ID
- VRK / 43329-K
- Conditions
- Burn
- Keywords
- Virtual Reality Ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR during burn care with Ketamine | Experimental | Behavioral: Virtual RealityComparing Virtual Reality during burn care with Ketamine |
| VR durin burn care without Ketamine | Experimental | Behavioral: Virtual RealityComparing virtual reality during burn care without Ketamine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe patient will receive virtual reality during a burn care procedure | Behavioural | VR durin burn care without Ketamine, VR during burn care with Ketamine |
Primary outcome
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Patterson, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual Reality in people with Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.