Local Anesthetics New Formulations: From Development to Clinical Tests

University of Campinas, Brazil30 enrolled

Overview

This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Local Anesthetic Effectiveness

Interventions

mepivacaineDRUG

One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Campinas

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Latency period and duration of anesthesia were assessed by an electrical pulp tester

Time frame: 10 minutes

Secondary Outcomes

Plasma concentrations of mepivacaine

Time frame: 0 to 360 minutes after the injection

Data from ClinicalTrials.gov

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