Liposomal Lidocaine Gel for Oral Topical Anesthesia

Anesthesia Clinical Trial

Official title:

Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425840
• Other study ID #: 112/2007
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2011
• Last updated: August 27, 2011
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of topical anesthetics on the oral mucosa.	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.	10 seconds	No