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The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.
Jellyfish stings are a common occurrence in many parts of the world causing significant morbidity to persons stung by jellyfish while participating in marine activities whether commercial or recreational. Much debate and confusion exist both in the medical literature and the common recommendations regarding how to treat persons stung by jellyfish. Specifically concerning what topical treatments are most efficacious at decreasing envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst, decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal recommendations and past studies have referenced numerous different topical treatments for jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits, ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old wine, salt water, cold packs, hot water, and commercial products such as Stingose and Stingaid. Conflicting data exists regarding what works and what does not for nematocysts discharge, skin erythema, and pain reaction.
The investigators would like to investigate which treatment is best out of some of the more commonly studied treatments for reducing pain and erythema.
The investigators would like to complete a research study to try to bring some reasonable evidence to the field treatment of jellyfish stings, namely, the decontamination process (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).
The questions asked are as follows:
Specifically, the investigators will be stinging human subject on both arms with a segment of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%), isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will include pain and erythema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetic Acid 5% | Experimental | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Sodium Bicarbonate Slurry (50%) | Experimental | Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Papain Slurry (70%) | Experimental | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Household ammonia (10%) | Experimental | Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Lidocaine (4%) | Experimental | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetic Acid (5%) | Other |
|
| |
| Sodium Bicarbonate Slurry (50%) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group. | 24 hours |
| Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20). | 30 minutes, 1 hour, and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Auerbach, MD | Division of Emergency Medicine, Stanford University Medical Center | Principal Investigator |
| Matthieu P DeClerck, MD | Division of Emergency Medicine, Stanford University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 90035 | United States |
Volunteers were excluded if they were pregnant, had a history of allergic reaction to prior jellyfish or insect sting, a family history of severe allergic reaction to jellyfish or insect sting, or a history of heart or lung disease.
Healthy human subjects were recruited by advertisement on Stanford University campus during the months of May and June, 2013 for a study that took place within a medical ward within a hospital during July, 2013. 97 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetic Acid 5% | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| FG001 | Sodium Bicarbonate Slurry (50%) | Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Sodium Bicarbonate Slurry (50%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| FG002 | Papain Slurry (70%) | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| FG003 | Household Ammonia (10%) | Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| FG004 | Lidocaine (4%) | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| FG005 | Isopropyl Alcohol (70%) | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). No treatment |
| FG006 | Hot Water (40 Degrees Celsius) | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
one patient treated with ammonia - adverse local skin reaction - this treatment arm therefore withdrawn from study
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetic Acid 5% | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment 11 males, 5 females treated |
| BG001 | Sodium Bicarbonate Slurry (50%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group. | one participant excluded because of adverse local skin reaction to household ammonia | Posted | Mean | 95% Confidence Interval | units on a scale | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetic Acid 5% | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | erythema |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Auerbach, MD | Division of Emergency Medicine, Department of Surgery, Stanford University School of Medicine | 650.725.9445 | auerbach@stanford.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| D000641 | Ammonia |
| D008012 | Lidocaine |
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Isopropyl Alcohol (70%) | Experimental | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Hot Water (40 degrees Celsius) | Experimental | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
|
| Other |
|
| Papain Slurry (70%) | Other |
|
|
| Ammonia (10%) | Other |
|
|
| Lidocaine (4%) | Drug |
|
|
| Isopropyl Alcohol (70%) | Other |
|
|
| Hot Tap Water (40 degrees Celsius) | Other |
|
|
| No treatment | Other |
|
|
Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment
8 males, 8 females treated
| BG002 | Papain Slurry (70%) | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment 9 males, 7 females treated |
| BG003 | Household Ammonia (10%) | Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment 1 female treated; adverse local skin reaction; study arm therefore withdrawn |
| BG004 | Lidocaine (4%) | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment 10 males, 6 females treated |
| BG005 | Isopropyl Alcohol (70%) | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment 8 makes, 8 females treated |
| BG006 | Heated Water (40 Degrees Celsius) | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Heated Tap Water (40 degrees Celsius) No treatment 8 males, 8 females treated |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Acetic Acid 5% | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment |
| OG001 | Sodium Bicarbonate Slurry (50%) | Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Sodium Bicarbonate Slurry (50%) No treatment |
| OG002 | Papain Slurry (70%) | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment |
| OG003 | Lidocaine (4%) | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment |
| OG004 | Isopropyl Alcohol (70%) | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment |
| OG005 | Hot Water (40 Degrees Celsius) | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment |
|
|
| Primary | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20). | Posted | Mean | 95% Confidence Interval | units on a scale | 30 minutes, 1 hour, and 24 hours |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sodium Bicarbonate Slurry (50%) | Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Sodium Bicarbonate Slurry (50%) No treatment | 0 | 16 | 0 | 16 |
| EG002 | Papain Slurry (70%) | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment | 0 | 16 | 0 | 16 |
| EG003 | Household Ammonia (10%) | Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment The first patient treated had an adverse local skin reaction, so this study arm was discontinued | 0 | 1 | 1 | 1 |
| EG004 | Lidocaine (4%) | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment | 0 | 16 | 0 | 16 |
| EG005 | Isopropyl Alcohol (70%) | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment | 0 | 16 | 0 | 16 |
| EG006 | Hot Water (40 Degrees Celsius) | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment | 0 | 16 | 0 | 16 |
| pain | Skin and subcutaneous tissue disorders | pain | Systematic Assessment |
|
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| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D020005 | Propanols |
| D000438 | Alcohols |