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NCT Number: NCT01744197

Synera Venipuncture Pain

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

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Palliative Care Pathological Conditions, Signs and Symptoms Perceptual Disorders Phlebotomy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

19 Locations Including

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synera (lidocaine 70mg/tetracaine 70mg)

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

US Oncology Research

Industry

Collaborators

  • Nuvo Research Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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