Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin

Overview

This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling.

Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 30, 2020

Detailed Description

This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.

For the primary goal – to examine the effects of oxytocin peripheral nerves after tissue injury – the investigators chose the controlled ultraviolet sunburn model.

The investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline.

In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand.

Pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von Frey filaments and an up-down sequential method which efficiently estimates median thresholds.

Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.

Interventions

  • Drug: Oxytocin
    • oxytocin (Pitocin®), 10 IU
  • Other: Placebo
    • Placebo (saline)

Arms, Groups and Cohorts

  • Active Comparator: Oxytocin
    • Intramuscular injection of oxytocin (Pitocin®), 10 IU
  • Placebo Comparator: Placebo
    • Intramuscular injection of (1 ml) of saline

Clinical Trial Outcome Measures

Primary Measures

  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 5 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 15 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 30 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 45 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 60 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 65 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Oxytocin injection
    • Time Frame: 120 minutes
    • Vibration frequency detection threshold in the burned area after IM Oxytocin injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 5 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 15 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 30 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 45 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 60 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 65 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Vibration frequency detection threshold (when vibration is first felt) after IM Saline injection
    • Time Frame: 120 minutes
    • Vibration frequency detection threshold in the burned area after IM Saline injection (Placebo) will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 5 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 15 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 30 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 45 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 60 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 65 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Oxytocin injection.
    • Time Frame: 120 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 5 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 15 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 30 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 45 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 60 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 65 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Pain threshold (the point where pain is first perceived) to a punctate mechanical stimulus after IM Saline injection (Placebo).
    • Time Frame: 120 minutes
    • Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Saline (Placebo) injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection.
    • Time Frame: 5 minutes
    • Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection.
    • Time Frame: 45 minutes
    • Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Oxytocin Injection.
    • Time Frame: 65 minutes
    • Hypersensitivity in the burned area after IM Oxytocin injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo).
    • Time Frame: 5 minutes
    • Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo).
    • Time Frame: 45 minutes
    • Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.
  • Hypersensitivity to von Frey filament (225 milliNewton) after IM Saline injection (Placebo).
    • Time Frame: 65 minutes
    • Hypersensitivity in the burned area after IM Saline (Placebo) injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured.

Secondary Measures

  • Sustained heat after IM Oxytocin injection
    • Time Frame: 21 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 22 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 23 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 24 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 25 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 41 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 42 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 43 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 44 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 45 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 61 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 62 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 63 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 64 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 65 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 121 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 122 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 123 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 124 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Oxytocin injection
    • Time Frame: 125 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin injection.
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 21 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 22 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 23 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 24 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 25 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 41 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 42 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 43 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 44 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 45 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 61 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 62 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 63 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 64 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 65 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 121 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 122 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 123 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 124 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).
  • Sustained heat after IM Saline injection (placebo)
    • Time Frame: 125 minutes
    • Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Saline injection (placebo).

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female > 18 and < 60 years of age,
  • Body Mass Index (BMI) <40
  • Generally in good health as determined by the Principal Investigator based on prior medical history
  • Normal blood pressure and resting heart rate without medication

Exclusion Criteria

  • Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
  • Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk
  • Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
  • Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James C Eisenach, MD, Principal Investigator, Wake Forest University Health Sciences
  • Overall Contact(s)
    • Regina Curry, 3367164294, RECURRY@WAKEHEALTH.EDU

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