A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn

Wake Forest University Health Sciences38 enrolled

Overview

This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?

The goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to Ultraviolet-B (UV-B) burn (mild sunburn). Researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Sunburn

Interventions

oxytocinDRUG

Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.

placeboDRUG

A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female \> 18 and ≤55 years of age, Body Mass Index (BMI) \<40 * Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3 * Fitzpatrick Scale rating I through III Exclusion Criteria: * History of skin cancer * Dark enough skin complexion that would make it infeasible to determine the minimal erythematous dose of UV-B irradiation. Anyone Fitzpatrick Scale score \>3 will be excluded * Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis * Pregnancy or currently breast feeding * Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval * Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy * Subjects with a known latex allergy

Locations (1)

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Difference between heat pain threshold

Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.

Time frame: 24 hours after UV-B exposure

Secondary Outcomes

Difference between heat pain threshold

Difference between heat pain threshold at 24 hours after UV-B exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 days after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.

Time frame: Two days after UV-B exposure

Touch and pain threshold to von Frey filament application

Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain.

Time frame: 24 hours after UV-B exposure

Touch and pain threshold to von Frey filament application

Time frame: Two days after UV-B exposure

Data from ClinicalTrials.gov

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