Low Dose Ketamine VR Analgesia During Burn Care Procedure

NCT ID: NCT01889537

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

VR during burn care with Ketamine

Comparing Virtual Reality during burn care with Ketamine

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

The patient will receive virtual reality during a burn care procedure

VR durin burn care without Ketamine

Comparing virtual reality during burn care without Ketamine.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

The patient will receive virtual reality during a burn care procedure

Interventions

Virtual Reality

The patient will receive virtual reality during a burn care procedure

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: lead

Responsible Party

David R. Patterson

PhD. ABPP, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Patterson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

43329-K

Identifier Type: -

Identifier Source: org_study_id