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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anesthesia

In brief

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.

Key facts

Study ID

NCT01844830

Run by

St. Renatus, LLC

People needed

90

Starts

2013-05-01

Expected to finish

2013-07-01

Last updated by the study team

2017-08-30

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Center for Dental Research Loma Linda University School — Loma Linda, California, United States
• Big Grins — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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