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Effective Treatments for Jellyfish Stings

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ClinicalTrials.gov Identifier: NCT02015195
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Paul S Auerbach, Stanford University

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.


Condition or disease Intervention/treatment Phase
Jellyfish Stings Other: Acetic Acid (5%) Other: Sodium Bicarbonate Slurry (50%) Other: Papain Slurry (70%) Other: Ammonia (10%) Drug: Lidocaine (4%) Other: Isopropyl Alcohol (70%) Other: Hot Tap Water (40 degrees Celsius) Other: No treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Acetic Acid 5%
Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Other: Acetic Acid (5%)
Other Name: Vinegar

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

Experimental: Sodium Bicarbonate Slurry (50%)
Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Other: Sodium Bicarbonate Slurry (50%)
Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

Experimental: Papain Slurry (70%)
Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Other: Papain Slurry (70%)
Other Name: Adolfo's Meat tenderizer

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

Experimental: Household ammonia (10%)
Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Other: Ammonia (10%)
Other Name: Household ammonia

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

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

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

Experimental: Isopropyl Alcohol (70%)
Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Other: Isopropyl Alcohol (70%)
Other Name: Rubbing alcohol

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.

Experimental: 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
Other: Hot Tap Water (40 degrees Celsius)
Other Name: Hot Water

Other: No treatment
Other Name: Nothing is given topically to treat sting. This is the control.




Primary Outcome Measures :
  1. Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours [ Time Frame: 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.

  2. Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015195


Locations
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United States, California
Stanford University Medical Center
Palo Alto, California, United States, 90035
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Paul S Auerbach, MD Division of Emergency Medicine, Stanford University Medical Center
Study Director: Matthieu P DeClerck, MD Division of Emergency Medicine, Stanford University Hospital

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Responsible Party: Paul S Auerbach, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02015195     History of Changes
Other Study ID Numbers: JSP-001
First Posted: December 19, 2013    Key Record Dates
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Paul S Auerbach, Stanford University:
Jellyfish stings
Treatment
Humans
Topical Treatments
Pain
Erythema

Additional relevant MeSH terms:
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Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Lidocaine
Ethanol
Acetic Acid
Retinol acetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents
Adjuvants, Immunologic
Immunologic Factors
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents