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Completed

NCT Number: NCT02015195

Effective Treatments for Jellyfish Stings

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Palo Alto, California, 90035, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetic Acid (5%)

Other

Other names: Vinegar

Sodium Bicarbonate Slurry (50%)

Other

Papain Slurry (70%)

Other

Other names: Adolfo's Meat tenderizer

Ammonia (10%)

Other

Other names: Household ammonia

Lidocaine (4%)

Drug

Other names: Liquid Lidocaine

Isopropyl Alcohol (70%)

Other

Other names: Rubbing alcohol

Hot Tap Water (40 degrees Celsius)

Other

Other names: Hot Water

No treatment

Other

Other names: Nothing is given topically to treat sting. This is the control.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2013
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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