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Liposomal Lidocaine Gel for Oral Topical Anesthesia

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ClinicalTrials.gov Identifier: NCT01425840
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Campinas, Brazil

Brief Summary:
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Lidocaine Phase 1

Detailed Description:
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa
Study Start Date : March 2008
Primary Completion Date : November 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Liposomal lidocaine, topical anesthesia
Efficacy of Liposomal lidocaine in topical anesthesia.
Drug: Lidocaine
100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
Other Name: Topical anesthesia in the palatal mucosa



Primary Outcome Measures :
  1. The efficacy of topical anesthetics on the oral mucosa. [ Time Frame: 10 seconds ]
    The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425840


Locations
Brazil
Piracicaba Dental School
Piracicaba, São Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications:
Responsible Party: University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01425840     History of Changes
Other Study ID Numbers: 112/2007
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by University of Campinas, Brazil:
Lidocaine,
liposome encapsulation,
topical anesthesia,
palatal mucosa

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action