Low Dose Ketamine VR Analgesia During Burn Care Procedure

Burn Clinical Trial

— VRK  

Official title:

Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889537
• Other study ID #: 43329-K
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2013
• Last updated: August 30, 2017
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2017
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Behavioral:
• Virtual Reality
The patient will receive virtual reality during a burn care procedure

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )