Trial Outcomes & Findings for Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients (NCT NCT01670487)

Results Overview

Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

pain of intravenous catheter placement.

Results posted on

2025-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Vapocoolant (Pain Ease Medium Stream) Application of the stream steadily 4 to 10 seconds onto the cannulation site. Vapocoolant: Topical stream of 4 to 10 seconds duration to skin	Nature's Tears Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin.
Overall Study STARTED	150	150
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vapocoolant (Pain Ease Medium Stream) n=150 Participants Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin	Nature's Tears n=150 Participants Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin	Total n=600 Participants Total of all reporting groups
Age, Continuous	52 years n=150 Participants	50 years n=150 Participants	51 years n=300 Participants
Sex: Female, Male Female	94 Participants n=150 Participants	64 Participants n=150 Participants	158 Participants n=300 Participants
Sex: Female, Male Male	56 Participants n=150 Participants	86 Participants n=150 Participants	142 Participants n=300 Participants

PRIMARY outcome

Timeframe: pain of intravenous catheter placement.

Population: adults undergoing placement of an intravenous line in the emergency department

Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.

Outcome measures

Outcome measures
Measure	Vapocoolant (Pain Ease Medium Stream) n=150 Participants Application of the stream steadily 4 to 10 seconds onto the cannulation site. Vapocoolant: Topical stream of 4 to 10 seconds duration to skin	Placebo (Nature's Tears) n=150 Participants Application of the stream steadily for 4 to 10 seconds
Pain Score on the Numeric Rating Scale (NRS)	2.3 NRS Standard Deviation 2.4	4.3 NRS Standard Deviation 3.0

Adverse Events

Vapocoolant (Pain Ease Medium Stream)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Nature's Tears

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vapocoolant (Pain Ease Medium Stream) n=150 participants at risk Application of the stream steadily 4 to 10 seconds onto the cannulation site. Vapocoolant: Topical stream of 4 to 10 seconds duration to skin	Nature's Tears n=150 participants at risk Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin.
Skin and subcutaneous tissue disorders skin irritation such as redness or blanching	10.7% 16/150 • Number of events 16	1.3% 2/150 • Number of events 2

Additional Information

Dr. Sharon Mace

Cleveland Clinic

Phone: 216-445-4598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place