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Use of the Synera patch for local anesthesia before vascular access procedures: a randomized, double-blind,
Saundra E Curry1, Julia C Finkel
1Columbia Presbyterian Hospital, New York, New York, USA.
Pain Medicine (Malden, Mass.)
|August 25, 2007
Summary
Synera, a lidocaine and tetracaine patch, effectively provides local anesthesia for vascular access procedures. A 20-minute application significantly reduced pain and was well-accepted by patients and clinicians.
Area of Science:
- Dermatology
- Anesthesiology
- Medical Devices
Background:
- Vascular access procedures require effective local anesthesia.
- Topical anesthetics aim to reduce pain and improve patient experience.
- Synera combines lidocaine and tetracaine with a heating device to accelerate anesthetic onset.
Purpose of the Study:
- To evaluate the efficacy of the Synera patch in providing local anesthesia.
- To compare Synera's anesthetic effect with a placebo before vascular access procedures.
Main Methods:
- A randomized, double-blind, placebo-controlled, paired study design.
- Adult volunteers received concurrent application of Synera and placebo.
- Pain intensity was assessed using the visual analog scale (VAS).
Main Results:
- Synera significantly reduced median VAS pain scores compared to placebo (5 mm vs 28 mm, P < 0.001).
- Adequate anesthesia was reported by 73% of subjects with Synera versus 31% with placebo (P = 0.002).
- Higher patient and investigator acceptance rates were observed with Synera.
Conclusions:
- A 20-minute application of Synera provides clinically useful local anesthesia for vascular access.
- Synera offers reduced time to adequate anesthesia and high acceptance.
- The drug delivery device is suitable for topical dermal anesthesia.
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