Synera Venipuncture Pain

US Oncology Network

Status and phase: Completed; Phase 2

Conditions: Phlebotomy; Pain; Palliative Care

Treatments: Drug: Synera (lidocaine 70mg/tetracaine 70mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01744197

12112

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

Arm 1

Experimental group

Description:

First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch

Treatment:

Drug: Synera (lidocaine 70mg/tetracaine 70mg)

Arm 2

Experimental group

Description:

First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch

Treatment:

Drug: Synera (lidocaine 70mg/tetracaine 70mg)