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

Exclusion Criteria

• •Inadequately controlled hypertension (blood pressure greater than 150/100 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 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 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 the 30 days prior to study participation.
• •History of congenital or idiopathic methemoglobinemia.