NCT01744197

Synera Venipuncture Pain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain
• Phlebotomy
• Palliative Care

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-02-01
• Completion: 2013-11-01
• First posted: 2012-12-06
• Last updated: 2018-10-25
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States