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).

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NEWS HIGHLIGHTS

Media Articles Related to Synera (Lidocaine / Tetracaine Topical)

Abdominal Surgery Without General Anesthesia
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.11.04]
A recent review in Faculty of 1000 Medicine Reports, a publication in which clinicians highlight advances in medical practice, suggests regional pain relief could be used during abdominal surgery. In this review, Michael Schaefer recommends a new approach that can be performed without the need for general anaesthetics.

Anesthesia, Exertional Heat Deaths May Be Linked
Source: MedicineNet Hyperthermia Specialty [2009.10.26]
Title: Anesthesia, Exertional Heat Deaths May Be Linked
Category: Health News
Created: 10/23/2009 4:10:00 PM
Last Editorial Review: 10/26/2009

Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Source: MedicineNet Hernia Specialty [2009.03.25]
Title: Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Category: Health News
Created: 3/25/2009 2:00:00 AM
Last Editorial Review: 3/25/2009

Need For Emergency Airway Surgery For Hard-to-Intubate Patients Reduced
Source: Respiratory / Asthma News From Medical News Today [2009.11.18]
Be prepared, that old Boy Scout motto, is being applied with great success to operating room patients whose anatomy may make it difficult for physicians to help them breathe during surgery, Johns Hopkins researchers report in a new study. When patients undergo general anesthesia, they stop breathing on their own and anesthesiologists must quickly insert a tube into the airway as a first step in machine-assisted breathing.

New Technique For Injectable Facial Fillers Improves Comfort, Recovery
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.29]
Less pain during injections for wrinkle-fighting facial fillers. Less swelling afterward. Less time in the office waiting for anesthesia to take effect. These and other benefits of a new injection technique that UT Southwestern Medical Center plastic surgeons are helping pioneer are outlined in the October issue of Plastic and Reconstructive Surgery.

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Published Studies Related to Synera (Lidocaine / Tetracaine Topical)

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.

Self-warming lidocaine/tetracaine patch effectively and safely induces local anesthesia during minor dermatologic procedures. [2005.02]
BACKGROUND: Dermatologic procedures often cause some degree of pain. A self-warming patch containing lidocaine and tetracaine (L/T) was developed to provide topical local anesthesia prior to painful procedures. OBJECTIVES: To evaluate the safety and efficacy of a self-warming L/T patch to provide anesthesia in adult patients undergoing minor dermatologic procedures... CONCLUSION: The self-warming L/T patch was effective in providing clinically useful local anesthesia for minor dermatologic procedures in adult patients.

Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. [2009.02]
BACKGROUND: We compared the lidocaine/tetracaine patch [Synera (USA), Rapydan (Europe)], a novel heat-aided patch using a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg, with a eutectic mixture of lidocaine 25 mg ml(-1) and prilocaine 25 mg ml(-1) (EMLA Cream). The agents were administered at different time periods for local topical anaesthesia before a vascular access procedure... CONCLUSIONS: The lidocaine/tetracaine patch provided effective anaesthesia with an application time as short as 10 min and was better than lidocaine/prilocaine cream at all application times shorter than 60 min, demonstrating a substantial improvement in time to onset of anaesthesia. The lidocaine/tetracaine patch provided an important alternative to lidocaine/prilocaine cream for topical local anaesthesia.

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Clinical Trials Related to Synera (Lidocaine / Tetracaine Topical)

Syneraâ„¢ for Epidural Needle Insertion [Completed]
We hypothesized that the analgesic effect of Syneraâ„¢ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.

Pharmacokinetic Study of Syneraâ„¢ in Neonates and Infants [Recruiting]
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome [Recruiting]
The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children [Recruiting]
The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.

Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections [Recruiting]

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