Overview

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