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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE VISCOUS


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All Clinical Trials for Lidocaine Hydrochloride Viscous

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001524 ↗ Thalidomide to Treat Oral Lesions in HIV-Infected Patients Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1996-06-01 This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
NCT01087489 ↗ Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye Completed Bascom Palmer Eye Institute N/A 2010-04-01 Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗ Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye Completed University of Miami N/A 2010-04-01 Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗ Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye Completed Miami VA Healthcare System N/A 2010-04-01 Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01612156 ↗ Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics Completed University of Southern California N/A 2011-12-01 The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
NCT01640171 ↗ Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival Completed Retina Vitreous Associates of Florida N/A 2012-07-01 Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: - Topical anesthetic drop: 21.48% - Topical viscous anesthetic: 23.33% - Topical anesthetic & soaked cotton-tip or pledget: 29.79% - Subconjunctival injection of anesthetic: 24.02% - Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).
NCT01898728 ↗ Comparison of the Effectiveness of Povidone-iodine in Reducing Conjunctival Bacterial Load Prior to Cataract Surgery in Patients Treated With a Lidocaine Gel Dilating Formulation Versus Eye Drops: A Randomized Controlled Trial Completed McMaster University N/A 2012-12-01 The eye contains a lens that focuses light. A clouding of the lens is known as a cataract. Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery is one of the most commonly performed surgical procedures. Although rare, complications of cataract surgery are significant given the number of people who have surgery each year and more serious complications may have a significant impact on the vision and quality of patients. Endophthalmitis is an infection in the eye and it is one of the worst complications of cataract surgery. Most of these infections are caused by bacteria from the patient's skin and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before cataract surgery, patients receive an umber of eye drops; many surgical centers have a combination of medications in a thick gel, so that the medications remain in the eye for a long period of time, which may improve their effect. Laboratory studies suggest that the antibacterial effect of cleaning solutions may be inhibited by gels but this has not been proven, and many believe it to be untrue. This study is to compare the amount of bacteria on the eye prior to surgery in patients receiving a gel formulation of the medications before surgery as compared to those receiving the same medication in eye drop (liquid) form.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lidocaine Hydrochloride Viscous

Condition Name

Condition Name for Lidocaine Hydrochloride Viscous
Intervention Trials
Pain 2
Burning Mouth Syndrome 1
Cataracts 1
Pelvic Floor Disorders 1
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Condition MeSH

Condition MeSH for Lidocaine Hydrochloride Viscous
Intervention Trials
Syndrome 2
Post-Dural Puncture Headache 1
Burning Mouth Syndrome 1
Macular Edema 1
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Clinical Trial Locations for Lidocaine Hydrochloride Viscous

Trials by Country

Trials by Country for Lidocaine Hydrochloride Viscous
Location Trials
United States 8
Canada 3
Denmark 1
Egypt 1
Thailand 1
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Trials by US State

Trials by US State for Lidocaine Hydrochloride Viscous
Location Trials
California 2
Florida 2
Maryland 2
Utah 1
New York 1
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Clinical Trial Progress for Lidocaine Hydrochloride Viscous

Clinical Trial Phase

Clinical Trial Phase for Lidocaine Hydrochloride Viscous
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Lidocaine Hydrochloride Viscous
Clinical Trial Phase Trials
Completed 9
Recruiting 3
Enrolling by invitation 2
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Clinical Trial Sponsors for Lidocaine Hydrochloride Viscous

Sponsor Name

Sponsor Name for Lidocaine Hydrochloride Viscous
Sponsor Trials
Vrije Universiteit Brussel 1
Lawson Health Research Institute 1
Walter Reed National Military Medical Center 1
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Sponsor Type

Sponsor Type for Lidocaine Hydrochloride Viscous
Sponsor Trials
Other 19
U.S. Fed 2
NIH 1
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Lidocaine Hydrochloride Viscous: Clinical Trials, Market Analysis, and Projections

Introduction

Lidocaine hydrochloride, particularly in its viscous form, is a widely used local anesthetic and pain reliever. This article delves into the clinical safety concerns, market analysis, and future projections for lidocaine hydrochloride viscous.

Clinical Safety Concerns

Use in Infants and Young Children

The use of viscous lidocaine 2% in infants and young children has raised significant safety concerns. Both the FDA and Health Canada have issued warnings against using this product for teething pain in this age group due to the risk of severe side effects such as seizures, severe brain injury, heart problems, and death[1][4].

  • FDA Findings: A review of the FDA’s Adverse Event Reporting System (FAERS) and medical literature identified 22 cases of toxicity, including six deaths, associated with the use of viscous lidocaine 2% in infants and young children aged 5 months to 3.5 years[4].

  • Health Canada Review: Although no similar cases were reported in Canada, Health Canada's safety review concluded that there is a link between the use of viscous lidocaine 2% and severe side effects in infants and young children. This led to updates in Canadian product information to include these warnings[1].

Market Analysis

Global Market Size and Growth

The global lidocaine hydrochloride market is experiencing steady growth driven by several factors:

  • Market Size: The market was valued at USD 0.773 billion in 2023 and is expected to reach USD 1.56 billion by 2034, with a CAGR of 6.57% during the forecast period[3].

  • Segmentation: The market is primarily segmented by dosage form, application, distribution channel, and region. The dental procedures segment dominates the market due to the widespread use of lidocaine hydrochloride for numbing during dental interventions[2][3].

Key Drivers of Growth

Several factors are driving the growth of the lidocaine hydrochloride market:

  • Increasing Surgical Procedures: The rise in surgical, dental, cosmetic, and plastic surgeries globally is a significant driver. For instance, the number of cosmetic surgeries in the U.S. increased by 19% since 2019[5].

  • Aging Population: The growing elderly population, which requires more frequent medical and surgical procedures, contributes to the market growth[2][5].

  • Technological Advancements: Progress in drug delivery technologies has led to the development of innovative formulations like creams and injections, enhancing the effectiveness and flexibility of lidocaine hydrochloride[2].

Distribution Channels

Retail pharmacies are expected to witness the highest growth during the forecast period due to increasing demand for efficient pain management solutions and growing awareness and accessibility of lidocaine products[2].

Regional Market Analysis

North America Dominance

North America dominates the global lidocaine hydrochloride market, driven by the rising number of aging people, increasing surgical procedures, and technological advancements in various medical fields[2][5].

Regulatory Scrutiny and Challenges

Safety Concerns and Regulatory Actions

Regulatory scrutiny is a significant challenge for the lidocaine hydrochloride market. The potential side effects associated with its use, particularly in infants and young children, require stringent adherence to safety standards and thorough approvals. Health Canada and the FDA have taken steps to update product information and warn against certain uses to mitigate these risks[1][4].

Competition from Alternative Solutions

The market also faces competition from alternative pain management solutions, which can impede growth. Continuous research to address safety concerns and improve formulations is necessary to maintain market share[2].

Future Projections

Market Growth Projections

The lidocaine hydrochloride market is expected to grow at a CAGR of 6.5% from 2024 to 2030, driven by the increasing number of surgical and dental procedures, rising prevalence of chronic pain conditions, and advancements in drug delivery technologies[5].

Emerging Applications

Lidocaine hydrochloride is expected to see growth in diverse and emerging applications across various medical specialties. For example, its use in cosmetic dermatology and as an adjuvant treatment for COVID-19 symptoms has highlighted its versatility and potential for expanded use[3][5].

"Lidocaine hydrochloride adeptly addresses the rising need for effective pain management solutions in the aging demographic. Furthermore, the market's momentum is strengthened by the versatility of lidocaine hydrochloride, providing diverse formulations like creams and injections to cater to a broad spectrum of medical requirements."[2]

Key Takeaways

  • Safety Concerns: Viscous lidocaine 2% should not be used for teething pain in infants and young children due to severe side effects.
  • Market Growth: The global lidocaine hydrochloride market is expected to grow significantly, driven by increasing surgical procedures and an aging population.
  • Regional Dominance: North America dominates the market due to technological advancements and a growing elderly population.
  • Regulatory Scrutiny: Continuous research and adherence to safety standards are crucial to address regulatory concerns and maintain market growth.

FAQs

Q: What are the safety concerns associated with using viscous lidocaine 2% in infants and young children?

A: The use of viscous lidocaine 2% in infants and young children is associated with severe side effects such as seizures, severe brain injury, heart problems, and death.

Q: Which segment dominates the lidocaine hydrochloride market?

A: The dental procedures segment dominates the market due to the widespread use of lidocaine hydrochloride for numbing during dental interventions.

Q: What are the key drivers of growth for the lidocaine hydrochloride market?

A: The key drivers include increasing surgical procedures, an aging population, and technological advancements in drug delivery technologies.

Q: Which region dominates the global lidocaine hydrochloride market?

A: North America dominates the global market due to the rising number of aging people and increasing surgical procedures.

Q: What are the challenges facing the lidocaine hydrochloride market?

A: The market faces challenges from regulatory scrutiny, potential side effects, and competition from alternative pain management solutions.

Sources:

  1. Health Canada - Summary Safety Review - Viscous Lidocaine 2% - Assessing the Potential Risk of Severe Side Effects in Infants and Young Children.
  2. Polaris Market Research - Lidocaine Hydrochloride Market Size, Share, Global Analysis Report.
  3. GlobeNewswire - Global Lidocaine Hydrochloride Market Report 2024, by Dosage Form, Application, by Distribution Channel, and By Region.
  4. FDA - FDA recommends not using lidocaine to treat teething pain.
  5. Grand View Research - Lidocaine Hydrochloride Market Size & Share Report, 2030.

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