Trial Outcomes & Findings for Vapocoolant (Pain Ease) Use for Venipuncture (NCT NCT01712776)

Results Overview

NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Less than 10 minutes after stream application.

Results posted on

2025-08-29

emergency department patients

Participant milestones
Measure	Placebo (Normal Saline, Nature&Apos;s Tears) Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site. Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.	Vapocoolant (Pain Ease Medium Stream ) Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Vapocoolant (Pain Ease) Use for Venipuncture

Baseline characteristics by cohort
Measure	Vapocoolant (Pain Ease Medium Stream ) n=50 Participants Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.	Nature's Tears n=50 Participants Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site. Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.	Total n=100 Participants Total of all reporting groups
Age, Continuous	52.98 years STANDARD_DEVIATION 13.42 • n=5 Participants	51.48 years STANDARD_DEVIATION 11.48 • n=7 Participants	52.23 years STANDARD_DEVIATION 12.45 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

Timeframe: Less than 10 minutes after stream application.

Population: equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups

NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)

Outcome measures
Measure	Vapocoolant (Pain Ease Medium Stream ) n=50 Participants Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.	Nature's Tears n=50 Participants Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site. Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.
Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)	1.7 units on a scale Standard Deviation 2.3	4.7 units on a scale Standard Deviation 2.9

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Vapocoolant (Pain Ease Medium Stream ) n=50 participants at risk Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.	Nature's Tears n=50 participants at risk Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site. Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.
Skin and subcutaneous tissue disorders Skin felt cool	4.0% 2/50 • Number of events 2 • 10 minutes Time frame = the time the patients were in the emergency department Skin assessments were done within 10 minutes after spray application	2.0% 1/50 • Number of events 1 • 10 minutes Time frame = the time the patients were in the emergency department Skin assessments were done within 10 minutes after spray application

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