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| Name | Class |
|---|---|
| Gebauer Company | NETWORK |
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To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation.
To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream.
Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapocoolant (Pain Ease Medium Stream) | Active Comparator | Application of the stream steadily 4 to 10 seconds onto the cannulation site. | |
| Nature's Tears | Placebo Comparator | Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapocoolant | Device | Topical stream of 4 to 10 seconds duration to skin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score on the Numeric Rating Scale (NRS) | 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. | pain of intravenous catheter placement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon E. Mace, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20682573 | Background | Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adults undergoing IV annulation in ED
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| ID | Title | Description |
|---|---|---|
| BG000 | Vapocoolant (Pain Ease Medium Stream) | Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin |
| BG001 | Nature's Tears | Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Score on the Numeric Rating Scale (NRS) | 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. | adults undergoing placement of an intravenous line in the emergency department | Posted | Mean | Standard Deviation | NRS | pain of intravenous catheter placement. |
|
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| 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 the stream steadily 4 to 10 seconds onto the cannulation site. Vapocoolant: Topical stream of 4 to 10 seconds duration to skin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation such as redness or blanching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Mace | Cleveland Clinic | 216-445-4598 | maces@ccf.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sterile water |
| Device |
Topical intervention of sterile water stream 4 to 10 seconds to skin. |
|
|
| 15102427 | Background | Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3. |
| 18434455 | Background | Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776. |
| 19920721 | Background | Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236. |
| 10876451 | Background | Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51. |
| 33292081 | Derived | Barbour T, O'Keefe S, Mace SE. Topical Refrigerant Spray for IVs: Patient/Provider Responses - Prospective, Double-blind, Randomized Study. West J Nurs Res. 2021 Aug;43(8):762-769. doi: 10.1177/0193945920976061. Epub 2020 Dec 8. |
| 28850378 | Derived | Mace SE. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Scand J Pain. 2017 Oct;17:8-15. doi: 10.1016/j.sjpain.2017.06.002. Epub 2017 Jul 10. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 150 |
| 16 |
| 150 |
| EG001 | 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. | 0 | 150 | 2 | 150 |
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