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The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Contains Lidocaine and Epinephrine |
|
| Placebo | Placebo Comparator | Contains Epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iontophoretic Drug Delivery System with Lidocaine/Epinephrine | Device | Active- 10.5% Lidocaine/0.179% Epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS). | 4 hours | |
| Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Determining the duration of anesthesia through standard pin prick testing. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Vince & Associates Clinical Research |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2009 | |
| Reset | Sep 29, 2009 |
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| Iontophoretic Drug Delivery System with Epinephrine | Device | Placebo- 0.179% Epinephrine |
|
| Overland Park |
| Missouri |
| 66212 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2009 | Sep 29, 2009 |