Running head: NASAL ANESTHESIA 1

Nasal Anesthesia Spray for Dentistry

Alissa Castellon and Marsha Tran

Lamar Institute of Technology

NASAL ANESTHESIA

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.

Keywords: Kovanaze, anesthesia, intranasal, oxymetazoline, tetracaine, needleless

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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. Kovanaze,

an intranasal spray, is a new consideration for a needleless anesthetic.

Kovanaze is an intranasal anesthetic made up of tetracaine and oxymetazoline that 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 Kovanaze 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
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nasal stent. Kollar noticed his teeth were numb once the stent was removed. The ENT said it was

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

protection (Baillie, 2016, p.1).

Kovanaze is designated for regional anesthesia when performing a restorative procedure

on teeth 4-13 and A-J in adults and children weighing more than 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 the plunger rod. Wait 10 minutes to let the

drug activate before starting a test drill. Kovanaze was launched at the American Dental

Association in October 2016 and was available for purchase the following month. It is only

available through dental dealers that have validated cold storage and cold chain distribution to

the dentists because it must be refrigerated. 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). This drug doesnt have an exact duration time, but it will last for
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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 side effects. These include, but are not limited to, high blood

pressure, nose bleeds, discomfort or difficulty swallowing or 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 recommended. Oxymetazoline-

containing products increase risk of hypertension, bradycardia and other adverse events

associated with oxymetazoline. Prior to administration of Kovanaze, it is recommended to

discontinue oxymetazoline-containing products for 24 hours.

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

their issue with a needleless anesthetic.

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
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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

the plunger rod. Wait 10 minutes to let the drug activate before starting a test drill. Its been used

on procedures up to 43 minutes. According to Cianco, et al. (2016), an estimated 30 to 40

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

for Dental Work. Retrieved March 18, 2017, from https://news.upenn.edu/news/penn-

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., . . .

Myneni, S. R. (2016). Comparison of 3 intranasal mists for anesthetizing maxillary teeth

in adults. The Journal of the American Dental Association,147(5), 339-347.

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Cohen, A. (2016, September 13). Should Dentists Use Kovanaze Nasal Spray? Retrieved March

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use-kovanaze-nasal-spray.

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approved-needle-free-dental-anesthesia-at-the-2016-american-dental-association-ada-

meeting/.

Webb, L. (2016). 'Needleless' intranasal spray. Rdh, 36(10), 58-68.