Lidopen (Lidocaine Hydrochloride) - Summary

LIDOPEN SUMMARY

Lidocaine Hydrochloride Injection, intramuscular for Cardiac Arrhythmias, is a non-pyrogenic, sterile solution prepared from lidocaine hydrochloride, USP and Water for Injection.

Lidocaine hydrochloride is indicated in the management of cardiac arrhythmias, particularly those of ventricular origin, such as occur with acute myocardial infarction.

The selection of the intramuscular route of administration (single dose) is justified in the following circumstances:

1. By a physician in whose opinion the potential benefits outweigh the possible risks even when ECG equipment is not available to verify the arrhythmia.
2. By, or under the supervision of, a physician, including mobile coronary care units, when facilities for intravenous administration are not readily available, or under circumstances where maintaining continuous intravenous therapy is difficult or impossible.
3. For use in the pre-hospital phase of suspected acute myocardial infarction by a patient who has transmitted his electrocardiogram with a CardioBeeper^®, whose electrocardiogram demonstrates the presence of a ventricular arrhythmia and who is instructed by qualified medical personnel to self-administer the LidoPen^® Auto-Injector.

NEWS HIGHLIGHTS

Media Articles Related to Lidopen (Lidocaine)

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 Lidopen (Lidocaine)

The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia. [2009.10]
BACKGROUND: In this study, we evaluated the effect of paracetamol on sensory and motor block onset time, tourniquet pain, and postoperative analgesia, when added to lidocaine in IV regional anesthesia (IVRA)... CONCLUSION: The addition of paracetamol during IVRA with lidocaine decreased tourniquet pain, increased anesthesia quality, and decreased postoperative analgesic consumption.

Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial. [2009.09.01]
BACKGROUND: The aim of this trial was to assess the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats... CONCLUSION: An echinacea/sage preparation is as efficacious and well tolerated as a chlorhexidine/lidocaine spray in the treatment of acute sore throats.

The impact of topical lidocaine on pain level assessment during and after vacuum-assisted closure dressing changes: a double-blind, prospective, randomized study. [2009.09]
BACKGROUND: Vacuum-assisted closure dressing changes are frequently painful. The authors hypothesized that administering topical lidocaine into the vacuum-assisted closure sponge would decrease pain during dressing changes... CONCLUSIONS: During the initial vacuum-assisted closure dressing change, 0.2% lidocaine administered through the suction tubing led to a reduction in pain reported by the patients in the authors' study. The duration of lidocaine administered in this fashion may be fairly short, because more patients in this group began to request small doses of opiates 30 minutes after the dressing change. Thus, lidocaine may improve patient comfort during vacuum-assisted closure therapy.

Lidocaine jelly and plain aqueous gel for urethral straight catheterization and the Q-tip test: a randomized controlled trial. [2009.09]
OBJECTIVE: To compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test... CONCLUSION: When compared with plain aqueous gel, 2% lidocaine jelly significantly reduces pain perception during evaluation of postvoid residual volume and the Q-tip test. LEVEL OF EVIDENCE: I.

Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. [2009.09]
BACKGROUND: Sentinel-lymph-node (SLN) mapping and biopsy maintains staging accuracy in early breast cancer and identifies patients for selective lymphadenectomy. SLN mapping requires injection of technetium-99m-sulfur colloid-an effective but sometimes painful method, for which better pain-management strategies are needed. In this randomised, double-blind trial, we compared degree of pain between standard radiocolloid injection and pH-adjusted and lidocaine-supplemented formulations for patients undergoing SLN mapping for breast cancer... INTERPRETATION: For centres that use radiocolloid injections for SLN mapping in patients with early breast cancer, the addition of 1% lidocaine to the radioisotope solution can improve patient comfort, without compromising SLN identification. FUNDING: US Military Cancer Institute, the Clinical Breast Care Project, and the Army Regional Anesthesia and Pain Management Initiative.

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Clinical Trials Related to Lidopen (Lidocaine)

J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion [Not yet recruiting]
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.

Lidocaine and Ketamine in Abdominal Surgery [Recruiting]
This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.

Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery [Recruiting]
This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and delirium after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

Intrauterine Lidocaine Infusion for Essure Sterilization Procedures [Recruiting]
The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter [Recruiting]
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects to determine the effect of topical nitroglycerin on radial artery vasodilation. In the first phase of the study, which is a dose escalation study, each subject will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. The subjects will then return at a later date at which point they will receive the alternate dose on one wrist and placebo on the other. In the second phase of the study, we will randomize the same patients to a mixture of topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be performed as in the first study.

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