Primary outcomeMean· From 5 minutes to 120 minutes
Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection
| Group | Value (Hz) | Spread |
|---|---|---|
| Oxytocin | 22 | 14 |
| Placebo | 21 | 8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
NCTNCT03935399 (opens ClinicalTrials.gov in a new tab)Other idIRB00056660
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 10 participants (actual)
- Sponsor
- Wake Forest University Health Sciences · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 8 Aug 2019
- Primary completion
- 15 Mar 2020
- Completion
- 30 Apr 2020
- First posted
- 2 May 2019
- Last update posted
- 5 Apr 2021
- Conditions
- Chronic Pain
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021
- Ph 4
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
NCT039353998 Aug 2019 to 30 Apr 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- OxytocinDrug
- SalineDrug
Arms2
Other
Oxytocin first, then saline placebo
Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day
Placebo comparator
Saline placebo first, then oxytocin
Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day
Primary outcomes4
Outcomes the sponsor listed as primary.
Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection
Time frame · From 5 minutes to 120 minutes
Registry description
Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo 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.
Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection.
Time frame · From 5 minutes to 120 minutes
Registry description
Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin or 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.
Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.
Time frame · From 5 minutes to 65 minutes
Registry description
Hypersensitivity in the burned area after IM Oxytocin or 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 in centimeters squared.
Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection
Time frame · From 5 minutes to 65 minutes
Registry description
Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin or placebo injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.
Secondary outcomes(3)
Change in Sustained Heat After IM Injection Non Dominant Arm
Time frame · From 21 minutes to 125 minutes
Registry description
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 or placebo injection.
Change in Sustained Heat After IM Injection
Time frame · From 36 minutes to 40 minutes
Registry description
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin or placebo injection.
Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)
Time frame · From 21 minutes to 65 minutes
Registry description
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 applied to the calf (lower leg) after IM Oxytocin or placebo injection.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· From 5 minutes to 120 minutes
Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection.
| Group | Value (grams) | Spread |
|---|---|---|
| Oxytocin | 0.20 | 0.66 |
| Placebo | 0.29 | 0.55 |
Primary outcomeMean· From 5 minutes to 65 minutes
Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.
| Group | Value (cm^2) | Spread |
|---|---|---|
| Oxytocin | 6.4 | 8.6 |
| Placebo | 8.8 | 8.6 |
Primary outcomeMean· From 5 minutes to 65 minutes
Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection
| Group | Value (Hz) | Spread |
|---|---|---|
| Oxytocin | 1.8 | 1.4 |
| Placebo | 1.7 | 3.9 |
Secondary and other outcome results(3)
Secondary outcomeMean· From 21 minutes to 125 minutes
Change in Sustained Heat After IM Injection Non Dominant Arm
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | -0.30 | 0.65 |
| Placebo | -0.70 | 0.84 |
Secondary outcomeMean· From 36 minutes to 40 minutes
Change in Sustained Heat After IM Injection
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin | 0.10 | 0.22 |
| Placebo | -0.20 | 0.45 |
Secondary outcomeMean· From 21 minutes to 65 minutes
Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin | -0.55 | 0.94 |
| Placebo | 0.10 | 0.55 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinOxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection | 0 / 10 | 0 / 10 | 0 / 10 |
| PlaceboSaline: 1.5 ml preservative free saline for intramuscular injection | 0 / 10 | 0 / 10 | 0 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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.
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