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Abstract
In dentistry, Kovanaze is the first FDA approved needleless anesthetic spray. It contains an
intranasal formula of 0.05% oxymetazoline and 3% tetracaine that numbs teeth 4-13 and A-J in
patients over 88 pounds. It is administered through the internal nasal valve at a 90 degree first
and then a 45 degree angle with an optional third dose for adults only at a 45 degree angle. It is a
regional anesthesia performed in restorative or cosmetic procedures that does not numb the lips
or cheeks. It was invented by Mark Kollar and Jim Mulvahill at St. Renatus, LLC.
Millions of people a year under go anesthesia. Dentists use anesthesia for multiple
procedures from filling composites to oral maxillofacial surgeries and everything in between. It
is used to block pain while the patient is conscious and is a temporary loss of sensation or
awareness. It can also be used to make you sleepy or forgetful and make you unconscious for
your surgery. According to National Institute of Medical Sciences (2015), this idea was
demonstrated in 1846 and the practice spread (p. 1). Local anesthesia numbs a small part of the
body for minor procedures. Regional anesthesia blocks pain to a larger part of the body. General
anesthesia affects your brain and the rest of your body. There are different types of anesthesia
that a dentist can choose from including gels, ointments, shots and others. The dentist and dental
hygienist will decide which anesthesia to use depending on the patients health, type of surgery,
and results from tests if any were taken such as blood tests or an electrocardiogram.
has been in development for over ten years and received the first United States Food & Drug
Administration approval on June 29, 2016. The developer of Kovanze Nasal Spray is St.
Renatus, LLC in Denver, Colorado. The name Kovanaze came from a company named after the
patron saint of anesthesia. According to Webb (2016), the company was founded for the
purpose to develop, commercialize, and distribute the first known intranasal dental local
anesthetic spray (p. 68). The co-founders of Kovanaze are Mark Kollar and Jim Mulvahill of
St. Renatus. The idea came about for Kovanaze when Kollar was playing basketball and was
struck in the chin, needing 21 stitches. A fellow player happened to be an ear nose and throat
specialist, who placed the sutures and also made a diagnoses due to a deviated nasal septum. The
ENT performed the septum repair and offered him a nasal spray having tetracaine to remove a
nasal stent. Kollar noticed his teeth were numb once the stent was removed. The ENT said it was
NASAL ANESTHESIA
reported that some other patients had the same sensation. Kollar, who is also a practicing dentist,
went to his office to test his teeth with a dental electronic pulp stimulator and found that they
were indeed numb (Baillie, 2016, p.1). Kollar founded the company together with his business
partner Mulvahill after this discovery. After they initiated the project, Kollar and Mulvahill
discovered that Bryan Clay, an ENT from Jackson, Mississippi, had a patent issued on the idea
of the intranasal dental anesthetic. All three specialist combined their resources with Kollar
taking the lead in the project of formulation and scientific development. Kollars research
refined the anesthesia formula, leading to the invention of Kovanaze and additional patent
on teeth 4-13 and A-J in adults and children weighing more than 88 pounds. Kovanaze was
launched at the American Dental Association in October 2016 and was available for purchase the
next month. It is only available through dental dealers that validated cold storage and cold chain
distribution to the dentists. The full retail value for a box of 30 single use sprayers is $675, which
is about $45 per patient but does not yet have a dental insurance code. Also, it is made here in the
USA. Merrick, Chief Executive Officer at St. Renatus (2017) said, for decades, needles have
been the mainstay for delivering dental anesthesia; now dentists have the option to offer patients
a regional anesthesia via a nasal spray for restorative procedures in the smile zone (p.1).
Oxymetazoline has a half-life of approximately two hours. This drug doesnt have an exact
duration time, but it will last for procedures from five minutes up to 43. The dilated arterioles
will have a vasoconstrictive action due to oxymetazoline component, which reduces the nasal
blood flow. Although the product is needleless, it still has some contraindications. These include,
but are not limited to, high blood pressure, nose bleeds, discomfort or difficulty swallowing or
NASAL ANESTHESIA
allergic reactions including rash, swelling, narrowing of the bronchi and shock. These are the
more common side effects related to this drug. Some of the drug interactions include Monoamine
oxidase inhibitors, nonselective beta-adrenergic antagonist, and tricyclic antidepressants that all
have the effect of concomitant use may cause hypertension. The use of these drugs are not
and other adverse events associated with oxymetazoline. Prior to administration of kovanaze, it
In dentistry, Kovanaze will be a very beneficial and useful addition given that patients
can be anesthetized for basic operative restorations and fixed restorations without being injected.
It is believed that cosmetic dentistry will have one of the greatest benefits due to the fact that the
lip will not be anesthetized. According to Cohen (2016), both the patient and practitioner will
be able to evaluate incisal edge position, patients smile, and lips at rest of their mock-ups,
temporaries, and final restorations (p.1). Patients may not have the same sensation that is
associated with injectable dental anesthetics such as numbness or tingling of the lips and cheeks.
This alone can improve patient gratification and can save time. Patients with needle-phobias will
more likely consider visiting the dentist to take care of their oral health knowing they can fix
Kovanaze is the first intranasal anesthetic spray in dentistry. It became available to the
market in November of 2016. Kovanaze is indicated for regional anesthesia when performing
restorative procedures on maxillary teeth from second premolar to second premolar and A-J on
children over 88 pounds. The dentist inserts the drug first towards the inferior meatus subnasale
and then for the second dose it is angled towards the middle meatus subnasale with a fast push of
the plunger rod. Wait 10 minutes to let the drug activate before starting a test drill. Its been used
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million Americans avoid visiting the dentist because of fear of pain and anesthetic injections (p.
339) and this is a better alternative for the patient who is afraid of needles or injections.
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References:
Anesthesia Fact Sheet. (2015, May). Retrieved March 18, 2017, from
https://www.nigms.nih.gov/education/pages/factsheet_Anesthesia.aspx.
Baillie, K. U. (2016, August 26). Penn Study Finds Nasal Spray Effective and Safe Anesthesia
study-finds-nasal-spray-effective-and-safe-anesthesia-dental-work.
Ciancio, S. G., Marberger, A. D., Ayoub, F., Garlapo, D. A., Pantera, E. A., Pantera, C. T., . . .
doi:10.1016/j.adaj.2015.11.009.
Cohen, A. (2016, September 13). Should Dentists Use Kovanaze Nasal Spray? Retrieved March
use-kovanaze-nasal-spray.
News. (2017, January 24). Retrieved March 18, 2017, from http://st-renatus.com/st-renatus-llc-
announces-the-product-launch-of-kovanaze%EF%A3%AA-nasal-spray-the-first-fda-
approved-needle-free-dental-anesthesia-at-the-2016-american-dental-association-ada-
meeting/.