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Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients

NCT01844830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-08-30

Study results available
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Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.

Conditions

  • Anesthesia

Interventions

DRUG

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Intranasally administered regional anesthetic

DRUG

Placebo

Inactive ingredients supplied in identical nasal sprayer

Sponsors & Collaborators

  • Triligent International

    collaborator INDUSTRY

  • Rho, Inc.

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01844830 on ClinicalTrials.gov