Synera Venipuncture Pain

September 27, 2018 updated by: US Oncology Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States
        • 19 Locations Including

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch
Drug: Synera (lidocaine 70mg/tetracaine 70mg)
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.
Other Names:
  • Synera
EXPERIMENTAL: Arm 2
First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch
Drug: Synera (lidocaine 70mg/tetracaine 70mg)
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.
Other Names:
  • Synera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With No or Minor Pain (VAS<3)
Time Frame: 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.
30 minutes after the venipuncture.
Percentage of Patients With No Pain (VAS=0)
Time Frame: 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.
30 minutes after the venipuncture.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Oncology Research

Collaborators

Nuvo Research Inc.

Investigators

  • Principal Investigator: Melanie Matson, RN, BSN, US Oncology Research, McKesson Specialty Health
  • Principal Investigator: Laura T. Guerra, RN, US Oncology Research, McKesson Specialty Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12112 (Research Ethic committee of Maisonneuve Rosemont Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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