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Synera Venipuncture Pain

This study is not yet open for participant recruitment.
Verified December 2012 by US Oncology Research
Sponsor:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT01744197
First received: December 4, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
Phlebotomy
Palliative Care
 Device: Synera (lidocaine 70mg/tetracaine 70mg)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures

Resource links provided by NLM:

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • The degree of pain experienced during venipuncture after being treated with the Synera patch vs with placebo patch. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The efficacy endpoints include the degree of pain reduction due to the needle stick experienced following the most recent administration of an analgesic drug, and how satisfied subjects are overall with the treatment provided to reduce pain by using the Global Assessment of Satisfaction with Venipuncture.


Secondary Outcome Measures:
  • Adverse events associated with the Synera patch vs placebo patch, primarily the degree of dermal irritation at each patch application site. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
First application: Synera patch; Second application: Placebo patch
 Device: 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 Name: Synera
Experimental: Arm 2
First application: Placebo patch; Second application: Synera patch
 Device: 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 Name: Synera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744197

Contacts
Contact: Shree Cooper, MS 281-863-4599 Shree.Cooper@McKesson.com

Locations
United States, Texas
19 Locations Including Not yet recruiting
Dallas, Texas, United States
Sponsors and Collaborators
US Oncology Research
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
  More Information

Publications:

Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01744197     History of Changes
Other Study ID Numbers: 12112
Study First Received: December 4, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by US Oncology Research:
Pain control
Needle stick pain
Venipuncture pain

Additional relevant MeSH terms:
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013