Synera Venipuncture Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744197
• Other study ID #: 12112
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2018
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Palliative Care
• Phlebotomy

Intervention

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.

Locations

Country	Name	City	State
United States	19 Locations Including	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
US Oncology Research	Nuvo Research Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/b — View Citation

Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010 Nov-Dec; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With No or Minor Pain (VAS<3)	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.
Primary	Percentage of Patients With No Pain (VAS=0)	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	Global Assessment of Satisfaction With Venipuncture	Rates of Satisfied and very satisfied are used to be compared between two groups.	30 minutes after the venipuncture.