Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Renatus, LLC
• Collaborators: Rho, Inc.; Triligent International
• Treatments: Oxymetazoline; Phenylephrine; Tetracaine

Criteria

Inclusion Criteria:

• Male or female 18 years of age or older.

• Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.

• Normal lip, nose, eyelid, and cheek sensation.

• Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.

• Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.

• Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.

• Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

• Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).

• Inadequately controlled active thyroid disease of any type.

• Frequent nose bleeds (≥ 5 per month).

• Having received dental care requiring a local anesthetic within the last 24 hours.

• 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 articaine, 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 take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)

• Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.

• Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.

• History of congenital or idiopathic methemoglobinemia