Synera Venipuncture Pain

Study Overview
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Brief Summary
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Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS

Official Title
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Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures

Conditions
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Pain, Phlebotomy, Palliative Care

Intervention / Treatment
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* Drug: Synera (lidocaine 70mg/tetracaine 70mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study. Is 18 years of age or older. Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment. Male or female patients Has signed the most recent Patient Informed Consent Form Has signed a Patient Authorization Form (HIPPA) Exclusion Criteria: Patients with sensitivity to lidocaine, tetracaine, or any other component of the product Known sensitivity to any components of test materials (sulphites and adhesives) Patients with damaged or broken skin at the designated patch site Pregnant or breastfeeding women patients Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit Previous irradiation to the site of the patch

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch | Drug: Synera (lidocaine 70mg/tetracaine 70mg)<br>* All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.<br>* Other names: Synera;|
| Experimental: Arm 2<br>First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch | Drug: Synera (lidocaine 70mg/tetracaine 70mg)<br>* All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.<br>* Other names: Synera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With No or Minor Pain (VAS<3) | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups. | 30 minutes after the venipuncture. | 
| Percentage of Patients With No Pain (VAS=0) | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups. | 30 minutes after the venipuncture. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Satisfaction With Venipuncture | Rates of Satisfied and very satisfied are used to be compared between two groups. | 30 minutes after the venipuncture. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain control, Needle stick pain, Venipuncture pain