Trial Outcomes & Findings for Effective Treatments for Jellyfish Stings (NCT NCT02015195)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

24 hours

Results posted on

2015-04-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Household Ammonia (10%) Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Lidocaine (4%) Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Isopropyl Alcohol (70%) Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). No treatment	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 Hot Tap Water (40 degrees Celsius) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).
Overall Study STARTED	16	16	16	1	16	16	16
Overall Study COMPLETED	16	16	16	0	16	16	16
Overall Study NOT COMPLETED	0	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	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 The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Household Ammonia (10%) Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Lidocaine (4%) Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).	Isopropyl Alcohol (70%) Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment). No treatment	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 Hot Tap Water (40 degrees Celsius) No treatment The left arm was always the active treatment arm; the right arm was the "control" arm (i.e., no treatment).
Overall Study Adverse Event	0	0	0	1	0	0	0

Baseline Characteristics

Effective Treatments for Jellyfish Stings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetic Acid 5% n=16 Participants 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	Sodium Bicarbonate Slurry (50%) n=16 Participants 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	Papain Slurry (70%) n=16 Participants 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	Household Ammonia (10%) n=1 Participants 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	Lidocaine (4%) n=16 Participants 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	Isopropyl Alcohol (70%) n=16 Participants 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	Heated Water (40 Degrees Celsius) n=16 Participants 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	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	16 Participants n=8 Participants	16 Participants n=8 Participants	97 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	43 Participants n=24 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	54 Participants n=24 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	1 participants n=4 Participants	16 participants n=21 Participants	16 participants n=8 Participants	16 participants n=8 Participants	97 participants n=24 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: one participant excluded because of adverse local skin reaction to household ammonia

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.

Outcome measures

Outcome measures
Measure	Acetic Acid 5% n=16 Participants Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment	Sodium Bicarbonate Slurry (50%) n=16 Participants 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	Papain Slurry (70%) n=16 Participants Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment	Lidocaine (4%) n=16 Participants Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment	Isopropyl Alcohol (70%) n=16 Participants Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment	Hot Water (40 Degrees Celsius) n=16 Participants Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment
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 Interval -0.31 to 0.55	-0.19 units on a scale Interval -0.63 to 0.25	-0.46 units on a scale Interval -0.9 to -0.01	-0.31 units on a scale Interval -0.76 to 0.126	-0.26 units on a scale Interval -0.7 to 0.17	0.42 units on a scale Interval -0.02 to 0.87

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Acetic Acid 5% n=16 Participants Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment	Sodium Bicarbonate Slurry (50%) n=16 Participants 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	Papain Slurry (70%) n=16 Participants Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment	Lidocaine (4%) n=16 Participants Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment	Isopropyl Alcohol (70%) n=16 Participants Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment	Hot Water (40 Degrees Celsius) n=16 Participants Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment
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 Interval -3.52 to 12.39	-12.07 units on a scale Interval -19.26 to -4.88	0.58 units on a scale Interval -7.37 to 8.55	-4.14 units on a scale Interval -11.56 to 3.27	2.11 units on a scale Interval -5.84 to 10.07	-4.11 units on a scale Interval -11.79 to 3.56

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acetic Acid 5% n=16 participants at risk Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Acetic Acid (5%) No treatment	Sodium Bicarbonate Slurry (50%) n=16 participants at risk 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	Papain Slurry (70%) n=16 participants at risk Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Papain Slurry (70%) No treatment	Household Ammonia (10%) n=1 participants at risk Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Ammonia (10%) No treatment The first patient treated had an adverse local skin reaction, so this study arm was discontinued	Lidocaine (4%) n=16 participants at risk Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Lidocaine (4%) No treatment	Isopropyl Alcohol (70%) n=16 participants at risk Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Isopropyl Alcohol (70%) No treatment	Hot Water (40 Degrees Celsius) n=16 participants at risk Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Hot Tap Water (40 degrees Celsius) No treatment
Skin and subcutaneous tissue disorders erythema	0.00% 0/16	0.00% 0/16	0.00% 0/16	100.0% 1/1 • Number of events 1	0.00% 0/16	0.00% 0/16	0.00% 0/16
Skin and subcutaneous tissue disorders pain	0.00% 0/16	0.00% 0/16	0.00% 0/16	100.0% 1/1 • Number of events 1	0.00% 0/16	0.00% 0/16	0.00% 0/16

Additional Information

Paul Auerbach, MD

Division of Emergency Medicine, Department of Surgery, Stanford University School of Medicine

Phone: 650.725.9445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place