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

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Sunburn

Treatments: Drug: oxytocin; Drug: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06651476

5P01NS119159 (U.S. NIH Grant/Contract)

IRB00120861

Details and patient eligibility

About

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?

Full description

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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

oxytocin

Experimental group

Description:

Two 30 minute infusions of oxytocin, 10 International Units (IU) separated by 30 minutes. To avoid potential unmasking by facial flushing which can occur at the beginning of high rates of oxytocin administration, the first infusion will consist of two steps beginning with a rate of 0.125 IU oxytocin per minute for 5 minutes, then increased to 0.375 IU oxytocin for 25 minutes. The second infusion will be a constant rate of 0.333 IU oxytocin per minute for 30 minutes.

Treatment:

Drug: oxytocin

placebo

Placebo Comparator group

Description:

Two 30 minute infusions of placebo separated by 30 minutes. The first infusion will consist of two steps, using an equivalent volume of placebo fluid infusion as in the oxytocin arm. This will consist of a slower rate in the first 5 minutes and more rapid rate for the last 25 min. The second placebo solution infusion will be a constant rate and volume equivalent to that used in the oxytocin arm.

Treatment:

Drug: placebo