Synera (Lidocaine / Tetracaine Topical) - Summary

SYNERA SUMMARY

Synera_TM
(lidocaine 70 mg and tetracaine 70 mg) topical patch

Synera™ consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetic. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The eutectic mixture has a melting point below room temperature and therefore exists as a liquid oil rather than as crystals. The surface area of the entire Synera patch is approximately 50 cm², 10 cm² of which is active.

Synera™ is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions (see CLINICAL STUDIES section).

See all Synera indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Synera (Lidocaine / Tetracaine Topical)

Concerns About Anesthesia's Impact On The Brain
Source: Pain / Anesthetics News From Medical News Today [2013.06.07]
As pediatric specialists become increasingly aware that surgical anesthesia may have lasting effects on the developing brains of young children, new research suggests the threat may also apply to adult brains...

Increasing Rates Of Emergency C-Section And Accompanying Emergency Anesthesia
Source: Pain / Anesthetics News From Medical News Today [2013.06.05]
There is an increasing need for safe emergency anaesthesia as cases of emergency Caesarean section (CS) continue to rise, said experts speaking at Euroanaesthesia, the annual congress of the European Society of Anaesthesiology (ESA)...

General Anesthesia Raises Dementia Risk Among Elderly Patients
Source: Pain / Anesthetics News From Medical News Today [2013.06.02]
Elderly patients who are exposed to general anesthesia have a 35% higher risk of developing dementia, researchers from INSERM and University of Bordeaux, France, reported at Euroanaesthesia, the annual congress of the European Society of Anaesthesiology (ESA)...

Faster Spinal Anesthesia For Cancer Patients At End Of Life
Source: Pain / Anesthetics News From Medical News Today [2013.05.29]
For patients with uncontrolled pain from terminal cancer, a new approach to calculating initial dosage may allow a quicker start of spinal analgesia - and less time in the hospital, according to a study in the June issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS)...

Patients With Sleep Apnea Undergoing Joint Replacement Have Improved Outcomes With Regional Anesthesia
Source: Pain / Anesthetics News From Medical News Today [2013.05.07]
Using regional anesthesia instead of general anesthesia in patients with sleep apnea undergoing total joint replacement decreases major complications by 17%, according to a study published online, ahead of print, in the journal Regional Anesthesia and Pain Medicine...

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Published Studies Related to Synera (Lidocaine / Tetracaine Topical)

Lidocaine/tetracaine patch (Rapydan) for topical anaesthesia before arterial access: a double-blind, randomized trial. [2012]
non-inferior to subcutaneous local anaesthetic... CONCLUSIONS: Both the lidocaine/tetracaine patch and subcutaneous injection of

Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. [2010.11]
BACKGROUND: The heated lidocaine/tetracaine patch (Synera; ZARS Pharma, Inc, Salt Lake City, UT) is among the local topical anesthetic formulations used to prevent procedural pain. This study was conducted to determine the depth and duration of anesthesia provided by the patch and to evaluate safety and tolerability... CONCLUSIONS: The heated lidocaine/tetracaine patch is well tolerated, and it provides favorable depth and duration of anesthesia without significant sensory loss for superficial venous access and minor dermatological procedures after a 30-min application.

Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized controlled trial. [2008.07]
STUDY OBJECTIVE: We compare the pain of intravenous (IV) cannulation in pediatric emergency department (ED) patients after applying a topical lidocaine/tetracaine patch versus placebo. We hypothesized that application of the active patch would reduce the pain of IV cannulation by at least 15 mm... CONCLUSION: Application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in pediatric ED patients and did not alter the rate of successful cannulations.

Brief Report: A randomized controlled trial of SyneraTM versus lidocaine for epidural needle insertion in labouring parturients: [Compte-rendu court : Une etude randomisee controlee du SyneraTM vs lidocaine dans l'insertion de l'aiguille peridurale chez les parturientes en travail]. [2008.03]
PURPOSE: Skin infiltration with lidocaine, although brief, can be very stressful, painful, and may perpetuate anxiety. Syneratrade mark, a local anesthetic patch, which contains an oxygen-activated heating component to enhance the delivery of a eutectic mixture of lidocaine (70 mg) and tetracaine (70 mg), has provided analgesia for minor, dermatological procedures. We hypothesized that the analgesic effect of Syneratrade mark, for pain in labouring parturients, would be superior to the traditional infiltration of lidocaine prior to epidural needle insertion... CONCLUSION: The Syneratrade mark patch provided inferior analgesia, for performing epidural labour analgesia in labouring parturients, compared to traditional infiltration with 2% lidocaine.

Randomized, double-blind, placebo-controlled study evaluating the lidocaine/tetracaine patch for induction of local anesthesia prior to minor dermatologic procedures in geriatric patients. [2005.03]
BACKGROUND: Topical anesthetics offer a noninvasive method of anesthesia. OBJECTIVE: To evaluate the efficacy and safety of the lidocaine/tetracaine patch, a 1:1 (wt:wt) eutectic mixture of lidocaine and tetracaine, for local anesthesia before minor dermatologic procedures in geriatric patients... CONCLUSION: The lidocaine/tetracaine patch is a safe and effective method for noninvasive induction of local anesthesia for minor dermatologic procedures in patients over the age of 65 years.

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Clinical Trials Related to Synera (Lidocaine / Tetracaine Topical)

In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction? [Recruiting]
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.

Synera Venipuncture Pain [Not yet recruiting]
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

Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children [Recruiting]
The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.

Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow [Recruiting]
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement [Not yet recruiting]
Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.

The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.

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