Effective Treatments for Jellyfish Stings

NCT02015195 | Completed Results

• 1 other identifier: JSP-001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Jellyfish Stings

Keywords

Jellyfish stings; Treatment; Humans; Topical Treatments; Pain; Erythema

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (7)

Acetic Acid 5%

EXPERIMENTAL

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

Other: Acetic Acid (5%); Other: No treatment

Sodium Bicarbonate Slurry (50%)

EXPERIMENTAL

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

Papain Slurry (70%)

EXPERIMENTAL

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

Other: Papain Slurry (70%); Other: No treatment

Household ammonia (10%)

EXPERIMENTAL

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

Other: Ammonia (10%); Other: No treatment

Lidocaine (4%)

EXPERIMENTAL

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

Drug: Lidocaine (4%); Other: No treatment

Isopropyl Alcohol (70%)

EXPERIMENTAL

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

Other: Isopropyl Alcohol (70%); Other: No treatment

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: Hot Tap Water (40 degrees Celsius); Other: No treatment

Interventions

Acetic Acid (5%) OTHER

Also known as: Vinegar

Acetic Acid 5%

Sodium Bicarbonate Slurry (50%) OTHER

Sodium Bicarbonate Slurry (50%)

Papain Slurry (70%) OTHER

Also known as: Adolfo's Meat tenderizer

Papain Slurry (70%)

Ammonia (10%) OTHER

Also known as: Household ammonia

Household ammonia (10%)

Lidocaine (4%) DRUG

Also known as: Liquid Lidocaine

Lidocaine (4%)

Isopropyl Alcohol (70%) OTHER

Also known as: Rubbing alcohol

Isopropyl Alcohol (70%)

Hot Tap Water (40 degrees Celsius) OTHER

Also known as: Hot Water

Hot Water (40 degrees Celsius)

No treatment OTHER

Also known as: Nothing is given topically to treat sting. This is the control.

Acetic Acid 5%; Hot Water (40 degrees Celsius); Household ammonia (10%); Isopropyl Alcohol (70%); Lidocaine (4%); Papain Slurry (70%); Sodium Bicarbonate Slurry (50%)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65 years
• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 90035, United States

Location

MeSH Terms

Conditions

Pain; Erythema

Interventions

Acetic Acid; Ammonia; Lidocaine; 2-Propanol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Gases; Inorganic Chemicals; Nitrogen Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Propanols; Alcohols

Results Point of Contact

• Title: Paul Auerbach, MD
• Organization: Division of Emergency Medicine, Department of Surgery, Stanford University School of Medicine

auerbach@stanford.edu

650.725.9445

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 19, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-04

Locations

US (1)