Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Virtual Reality Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low-dose pain medication

80min IV infusion of a low-dose pain medication

Group Type ACTIVE_COMPARATOR

Low-dose pain medication (Ketalar) and saline placebo

Intervention Type DRUG

saline placebo

80min IV infusion of a saline placebo

Group Type PLACEBO_COMPARATOR

Low-dose pain medication (Ketalar) and saline placebo

Intervention Type DRUG

Interventions

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Low-dose pain medication (Ketalar) and saline placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes