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Effective Treatments for Jellyfish Stings

Primary Purpose

Jellyfish Stings

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetic Acid (5%)
Sodium Bicarbonate Slurry (50%)
Papain Slurry (70%)
Ammonia (10%)
Lidocaine (4%)
Isopropyl Alcohol (70%)
Hot Tap Water (40 degrees Celsius)
No treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jellyfish Stings focused on measuring Jellyfish stings, Treatment, Humans, Topical Treatments, Pain, Erythema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Acetic Acid 5%

Sodium Bicarbonate Slurry (50%)

Papain Slurry (70%)

Household ammonia (10%)

Lidocaine (4%)

Isopropyl Alcohol (70%)

Hot Water (40 degrees Celsius)

Arm Description

Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
December 4, 2013
Last Updated
April 10, 2015
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02015195
Brief Title
Effective Treatments for Jellyfish Stings
Official Title
Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jellyfish Stings
Keywords
Jellyfish stings, Treatment, Humans, Topical Treatments, Pain, Erythema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetic Acid 5%
Arm Type
Experimental
Arm Description
Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Sodium Bicarbonate Slurry (50%)
Arm Type
Experimental
Arm Description
Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Papain Slurry (70%)
Arm Type
Experimental
Arm Description
Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Household ammonia (10%)
Arm Type
Experimental
Arm Description
Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Lidocaine (4%)
Arm Type
Experimental
Arm Description
Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Isopropyl Alcohol (70%)
Arm Type
Experimental
Arm Description
Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Arm Title
Hot Water (40 degrees Celsius)
Arm Type
Experimental
Arm Description
Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Intervention Type
Other
Intervention Name(s)
Acetic Acid (5%)
Other Intervention Name(s)
Vinegar
Intervention Type
Other
Intervention Name(s)
Sodium Bicarbonate Slurry (50%)
Intervention Type
Other
Intervention Name(s)
Papain Slurry (70%)
Other Intervention Name(s)
Adolfo's Meat tenderizer
Intervention Type
Other
Intervention Name(s)
Ammonia (10%)
Other Intervention Name(s)
Household ammonia
Intervention Type
Drug
Intervention Name(s)
Lidocaine (4%)
Other Intervention Name(s)
Liquid Lidocaine
Intervention Type
Other
Intervention Name(s)
Isopropyl Alcohol (70%)
Other Intervention Name(s)
Rubbing alcohol
Intervention Type
Other
Intervention Name(s)
Hot Tap Water (40 degrees Celsius)
Other Intervention Name(s)
Hot Water
Intervention Type
Other
Intervention Name(s)
No treatment
Other Intervention Name(s)
Nothing is given topically to treat sting. This is the control.
Primary Outcome Measure Information:
Title
Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours
Description
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
Title
Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Auerbach, MD
Organizational Affiliation
Division of Emergency Medicine, Stanford University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthieu P DeClerck, MD
Organizational Affiliation
Division of Emergency Medicine, Stanford University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
90035
Country
United States

12. IPD Sharing Statement

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Effective Treatments for Jellyfish Stings

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