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Synera Venipuncture Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744197
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : February 17, 2016
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
US Oncology Research

Study Description
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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

Condition or disease Intervention/treatment Phase
Pain Phlebotomy Palliative Care Drug: Synera (lidocaine 70mg/tetracaine 70mg) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
Study Start Date : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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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 Name: 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 Name: Synera


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744197


Locations
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United States, Texas
19 Locations Including
Dallas, Texas, United States
Sponsors and Collaborators
US Oncology Research
Nuvo Research Inc.
Investigators
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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
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Publications of Results:

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Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01744197    
Other Study ID Numbers: 12112
First Posted: December 6, 2012    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: October 25, 2018
Last Verified: September 2018
Keywords provided by US Oncology Research:
Pain control
Needle stick pain
Venipuncture pain
Additional relevant MeSH terms:
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Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action