Status:
COMPLETED
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
Lead Sponsor:
St. Renatus, LLC
Collaborating Sponsors:
Triligent International
Rho, Inc.
Conditions:
Anesthesia
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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.
Detailed Description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing ...
Eligibility Criteria
Inclusion
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.
- Normal lip, nose, eyelid, and cheek sensation.
- Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth).
Exclusion
- Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
- Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)
- Inadequately controlled thyroid disease of any type.
- Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- Frequent nose bleeds (≥ 5 per month).
- History of congenital or idiopathic methemoglobinemia.
- Presence of an upper respiratory infection and/or fever defined as body temperature ≥100.4° (38°C) on the day of and prior to study drug administration.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01844830
Start Date
May 1 2013
End Date
July 1 2013
Last Update
August 30 2017
Active Locations (2)
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1
Center for Dental Research Loma Linda University School
Loma Linda, California, United States, 92350
2
Big Grins
Fort Collins, Colorado, United States, 80525