Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gebauer Company | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adults (excluding the very old, > 80 years old) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapocoolant (Pain Ease Medium Stream ) | Active Comparator | Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. |
|
| Nature's Tears Sterile Water | Placebo Comparator | Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapocoolant (Pain Ease) | Device | Topical stream 4-10 seconds duration to skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10) | Less than 10 minutes after stream application. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon E. Mace, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18591524 | Background | Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874. | |
| 19208703 | Background | Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
emergency department patients
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
pain after spray with placebo or vapocoolant
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Nature's Tears |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10) | 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 | Posted | Mean | Standard Deviation | units on a scale | Less than 10 minutes after stream application. |
|
10 minutes
Time frame = the time the patients were in the emergency department Skin assessments were done within 10 minutes after spray application
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin felt cool | Skin and subcutaneous tissue disorders | other | Systematic Assessment | "skin felt cool" at 10 minutes no skin abnormalities seen |
This study enrolled only adults. No pediatric patients were enrolled. However, an earlier study by Farion KJ et al in CMAJ in 2008 found that the use of a vapocoolant (pain-ease) significantly decreased the pain of intravenous cannulation in children
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon E. Mace, Director of Research, ESI | Cleveland Clinic | (216) 445-4598 | maces@ccf.org |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nature's Tears Sterile Water | Device | Topical stream 4-10 seconds duration to skin |
|
| 26979261 | Derived | Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| EG001 | Nature'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. | 0 | 50 | 1 | 50 |
|
Not provided
Not provided
Not provided