In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?

Conditions
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Pain on Propofol IV Injection

Intervention / Treatment
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* Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)
* Drug: Gebauer's Ethyl Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, outpatient children, 6-17 years old American Society of Anesthesiologist Physical Classification rating of 1 or 2 Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas Exclusion Criteria: Skin disease or infection (on dorsum of hands) Allergy to lidocaine or tetracaine

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ethyl chloride vapocoolant spray<br>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. | Drug: Gebauer's Ethyl Chloride<br>* 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.<br>* Other names: NDC 45951-0123;|
| Experimental: Synera Patch<br>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. | Device: lidocaine/tetracaine transdermal patch (NDC 43469-864-01)<br>* 70 mg lidocaine / 70 mg tetracaine<br>* Other names: NDC 43469-864-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: - no pain - mild pain (associated with facial expression of pain) - moderate pain (pulling/withdrawal of the arm) - severe pain (screaming) | Within one hour, plus or minus one half hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, Pain, Synera Patch, Gebauer's Ethyl Chloride topical anesthetic