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| Name | Class |
|---|---|
| ZARS Pharma Inc. | INDUSTRY |
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The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.
The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ethyl chloride vapocoolant spray | Active Comparator | Half of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch. |
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| Synera Patch | Experimental | The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter. Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4. Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine/tetracaine transdermal patch (NDC 43469-864-01) | Device | 70 mg lidocaine / 70 mg tetracaine |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of children in each group who do not feel pain or have mild pain on propofol injection. | The primary outcome variable is the success/failure of therapy. The therapy is considered a success if a child feels no pain OR has mild pain. | Within one hour, plus or minus one half hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | A blinded independent observer and a blinded anesthesiologist will rate pain on propofol injection according to a pain scale:
| Within one hour, plus or minus one half hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samia N Khalil, M.D. | Contact | 713.500.6242 | samia.n.khalil@uth.tmc.edu | |
| Mohammed Ali, M.D. | Contact | 713.500.6194 | mohammed.ali@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samia N Khalil, M.D. | University of Texas Health Sciences Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Herman Hospital | Recruiting | Houston | Texas | 77030 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2015 | |
| Reset | Jan 15, 2016 | |
| Release | May 13, 2016 |
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| Gebauer's Ethyl Chloride | Drug | Spray is to be applied topically to skin (dorsum of the hand for study purposes)until it turns white or for up to 10 seconds. |
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|
| Reset | Jun 21, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2015 | Jan 15, 2016 | |||
| May 13, 2016 | Jun 21, 2016 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005018 | Ethyl Chloride |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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