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Synera Venipuncture Pain

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Phlebotomy; Palliative Care

Intervention: Synera (lidocaine 70mg/tetracaine 70mg) (Device)

Phase: Phase 2

Status: Completed

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Melanie Matson, RN, BSN, Principal Investigator, Affiliation: US Oncology Research, McKesson Specialty Health
Laura T. Guerra, RN, Principal Investigator, Affiliation: US Oncology Research, McKesson Specialty Health

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The degree of pain experienced during venipuncture after being treated with the Synera patch vs with placebo patch.

Secondary outcome: Adverse events associated with the Synera patch vs placebo patch, primarily the degree of dermal irritation at each patch application site.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

19 Locations Including, Dallas, Texas, United States
Additional Information

Starting date: January 2013
Last updated: May 19, 2014

Page last updated: August 23, 2015

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