LidoSite™ Topical System
comprised of the
LidoSite ™ Patch
(Lidocaine HCl / Epinephrine topical iontophoretic patch) 10%/0.1%
LidoSite ™ Controller
The LidoSite™ Topical System (LidoSite™ System) consists of a LidoSite™ Patch and a LidoSite™ Controller, a portable microprocessor-controlled battery-powered DC current source. The LidoSite™ System delivers lidocaine and epinephrine simultaneously by topical iontophoresis to achieve dermal analgesia on intact skin. Iontophoresis is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin.
LidoSite™ System is a topical local anesthetic delivery system indicated for use on normal intact skin to provide local analgesia for superficial dermatological procedures such as venipuncture, intravenous cannulation, and laser ablation of superficial skin lesions.
LidoSite™ System is indicated for use on patients 5 years of age and older.
Clinical Trials Related to Lidosite (Lidocaine / Epinephrine Iontophoresis)
Gluing Lacerations Utilizing Epinephrine [Completed]
Minor lacerations are a commonly treated injury in the paediatric emergency department .
Over the past decade, standard closure of these lacerations has evolved from suture repair
to closure with tissue adhesive (also referred to as "skin glue"). Local anaesthetic is not
routinely used during application of skin glue as it was with sutures. There are, however,
several potential advantages to pre-treating wounds with topical LET
(Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive
properties. Some believe LET can improve patient comfort, increase the ease of glue
application, and lead to better healing when used on lacerations being repaired with tissue
adhesive. This study aims to address the question of whether or not pre-treatment with LET
improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is
that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual
Analog Scale) during repair with tissue adhesive.
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution [Completed]
Scalp infiltration with Epinephrine- containing lidocaine solution is common method for
craniotomy but it may result in transient but significant hypotension in patients undergoing
neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently
reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine
response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus
theologically appropriate for reducing bleeding during scalp incision in craniotomy.
The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on
hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers. [Enrolling by invitation]
The purpose of the study is to compare two modalities of local anesthetic administration
prior to the placement of cosmetic facial injectable fillers. Both short and long term pain
perceptions for the facial filler procedure will be compared in patients receiving 4%
Topicaine gel on half their face and 2% lidocaine 1: 100k epinephrine nerve block injections
on the other half of their face. The objective is to quantify the subjective pain
experienced by these two modalities of local anesthetic during the procedure of Juvederm XC
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery [Completed]
The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test
dose administration on the PK profile of a single epidural dose of DepoDur (extended-release
epidural morphine) in patients undergoing major upper abdominal surgery. A secondary
objective was to evaluate the safety and efficacy profile.
Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery [Completed]
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton
pregnancies, in 9. 1% of all twins and 9. 9% of monochorionic twins. IUGR in monochorionic
twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous
demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or
severe neurologic handicap (up to 30% risk) of the other twin. These complications result
from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin
through placental vascular communications.
Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are
mediated through placental vascular anastomoses, we have proposed obliterating such
anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to
identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV
communications are identified on the surface of the placenta by noting that the terminal end
of the artery of one of the fetuses does not have a corresponding returning vein to the same
fetus. We have speculated that the separation of the circulations may be of benefit in
monochorionic twins affected by SIUGR by preventing the adverse effects that may result from
the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical
trial the outcome of SIUGR managed either expectantly or with SLPCV.
Study procedures will begin with confirmation of the diagnosis and screening criteria at the
Qualified Clinical Center. The patient will sign the appropriate consents and then be
randomized to her treatment group. Enrollment data will be submitted to the research
coordinator in Coordinating Center in Tampa. Expectant management patients will be treated
by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa
General Hospital or qualified laser center. They may return to the referring center for
follow-up. After delivery, outcome data will be sent to the research coordinator in
Coordinating Center in Tampa.
Page last updated: 2007-09-10