Jellyfish Stings
Conditions
Keywords
Jellyfish stings, Treatment, Humans, Topical Treatments, Pain, Erythema
Brief summary
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: * What topical treatments for jellyfish stings actually decrease the amount of inflammation seen on a macroscopic level on the skin of humans? * What topical treatments for jellyfish stings actually decrease the sensation of pain in humans? * Do topical chemical treatments cause different outcomes when exposed to the above parameters? * Do different species of jellyfish nematocysts react differently based on the type of topical chemical treatment used? What is the variation of effects of topical treatments based on the species of jellyfish sting? 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.
Interventions
OTHERAcetic Acid (5%)
OTHERSodium Bicarbonate Slurry (50%)
OTHERPapain Slurry (70%)
OTHERAmmonia (10%)
DRUGLidocaine (4%)
OTHERIsopropyl Alcohol (70%)
OTHERHot Tap Water (40 degrees Celsius)
OTHERNo treatment
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-65 years * Healthy volunteers
Exclusion criteria
* Known history of allergic reaction or anaphylaxis to prior Cnidaria sting of there envenomations * Family history of anaphylaxis to any sting from either Cnidaria, bee, or wasp * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | 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. |
| Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | 30 minutes, 1 hour, and 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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
8 males, 8 females treated | 16 |
| 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 | 16 |
| 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 | 1 |
| 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 | 16 |
| 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 | 16 |
| 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 | 16 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Acetic Acid 5% | Sodium Bicarbonate Slurry (50%) | Papain Slurry (70%) | Household Ammonia (10%) | Lidocaine (4%) | Isopropyl Alcohol (70%) | Heated Water (40 Degrees Celsius) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 16 Participants | 1 Participants | 16 Participants | 16 Participants | 16 Participants | 97 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 16 participants | 1 participants | 16 participants | 16 participants | 16 participants | 97 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 7 Participants | 1 Participants | 6 Participants | 8 Participants | 8 Participants | 43 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 9 Participants | 0 Participants | 10 Participants | 8 Participants | 8 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 1 / 1 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 1 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
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).
Time frame: 30 minutes, 1 hour, and 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acetic Acid 5% | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | 4.43 units on a scale |
| Sodium Bicarbonate Slurry (50%) | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | -12.07 units on a scale |
| Papain Slurry (70%) | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | 0.58 units on a scale |
| Lidocaine (4%) | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | -4.14 units on a scale |
| Isopropyl Alcohol (70%) | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | 2.11 units on a scale |
| Hot Water (40 Degrees Celsius) | Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours | -4.11 units on a scale |
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.
Time frame: 24 hours
Population: one participant excluded because of adverse local skin reaction to household ammonia
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acetic Acid 5% | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | 0.13 units on a scale |
| Sodium Bicarbonate Slurry (50%) | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | -0.19 units on a scale |
| Papain Slurry (70%) | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | -0.46 units on a scale |
| Lidocaine (4%) | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | -0.31 units on a scale |
| Isopropyl Alcohol (70%) | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | -0.26 units on a scale |
| Hot Water (40 Degrees Celsius) | Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours | 0.42 units on a scale |