Synera Venipuncture Pain

Phase 2

Completed

Brief Summary: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm 2	Synera (lidocaine 70mg/tetracaine 70mg)	First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch
Arm 1	Synera (lidocaine 70mg/tetracaine 70mg)	First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With No or Minor Pain (VAS<3)	30 minutes after the venipuncture.	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.
Percentage of Patients With No Pain (VAS=0)	30 minutes after the venipuncture.	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.

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Satisfaction With Venipuncture	30 minutes after the venipuncture.	Rates of Satisfied and very satisfied are used to be compared between two groups.