Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Ketamine

Brief Summary

The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.

Intervention / Treatment

  • Low-dose pain medication (Ketalar) and saline placebo (DRUG)
    N/A

Condition or Disease

  • Virtual Reality Therapy

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other|NIH
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2013
    Primary Completion: Jun 01, 2014 ESTIMATED
    Completion Date: Jun 01, 2014 ESTIMATED
    Study First Posted: Apr 26, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 25, 2013

    Sponsors / Collaborators

    Lead Sponsor: University of Washington
    Responsible Party: N/A

    Location

    Seattle, Washington, USA

    This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

    Participant Groups

    • 80min IV infusion of a low-dose pain medication

    • 80min IV infusion of a saline placebo

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Healthy male and females between the age of 18 and 60 years
    * Ability to communicate orally
    * Ability to read and understand English
    * Body Mass Index between 20-35

    Exclusion Criteria:

    * Women who are pregnant, trying to become pregnant, or who are breastfeeding
    * History of alcohol or substance abuse
    * Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
    * Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
    * Predisposition to severe motion sickness
    * Unusual sensitivity or lack of sensitivity to pain
    * Urine toxicology positive for opioids or benzodiazepines

    Primary Outcomes
    • Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World. Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.

    More Details

    NCT Number: NCT01840774
    Other IDs: 43929
    Study URL: https://clinicaltrials.gov/study/NCT01840774
    Last updated: Sep 29, 2023