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Contraindications (Hersh etal.2016b; US Food and Drug Asministration2019)
General contraindications: Allergy to any of the components of the solution –
ester local anesthetics, (tetracaine, benzocaine, pro­caine and para-
aminobenzoic acid), oxymetazoline,
and benzyl alcohol– is an absolute contraindication.
Children who weigh less than 40 kg (generally chil-
dren aged under 12
Epistaxis. Intranasal maxillary local anesthesia is not
years).
advised in patients with five or more nose bleeds per month.
Contraindications for oxymetazoline. It is important to
remember that the drug has a long half-
life (2 hours)
(Giannakopoulos etal.2012):
Uncontrolled hypertension. There is potential for a
hypertensive event due to the vasoconstrictive effects of oxymetazoline. Nevertheless, the provider is advised to monitor blood pressure.
Uncontrolled or active thyroid disease (Ciancio
etal.2013).
Interactions with the following medications may lead
to a hypertensive reaction (Chapter10):
Nonselective beta- adrenergic blocking agents
(Table10.4, Chapter10).
Tricyclic antidepressants (Table10.5, Chapter10).
Monoamine oxidase inhibitor antidepressants
(Table10.5, Chapter10).
Administration of other intranasal medications and/
or products containing oxymetazoline in the previous 24
hours.
Contraindications for tetracaine: History of congenital or idiopathic methemoglobine-
mia because although the literature suggests a lower association with tetracaine, the risk still exists (Levergne etal.2006; Guay2009).
Spray tip
Air bubble
Figure20.13 Parts of the prefilled sprayer.  Redrawn,
with modifications, from Kovanaze
Barrel
Glass lid
®
instructions for use.
Finger grip
Plunger
disinfectant, or used if dropped on the ground. It should not be placed in a cartridge warmer (Highlights2016).
Preparation
Remove two or three prefilled sprayers from the packet
using the finger grip. We remove two or three because this is the quantity to be used during the session (see below).
Check the expiration date (on both the carton and the
sprayer label). Check that the solution is clear and color­less. Note: The presence of a bubble is normal and does not interfere with the product or dosing. Do not expel the air bubble prior to dosing patient (Figure20.13).
Install the finger grip. Snap the finger grip onto the top of
the sprayer barrel next to the glass lip (Figure20.14a,b).
Remove the gray cap from the prefilled sprayer
(Figure20.14c). The device is now ready for use.
Technique
The technique for using Kovanaze® follows a well­established protocol for administration, which we describe below (Ciancio et al. 2013, 2016; Hersh et al. 2016b; Highlights2016):
Equipment
Kovanaze® comes in a prepackaged spray device (similar to a syringe without the needle), known as a prefilled sprayer or nasal spray (Figure20.13). The device consists of 3% tetracaine hydrochloride (30 mg/ml) and 0.05% oxymetazoline chloride (0.5 mg/ml) delivered as a single
0.2- ml dose. In other words, each intranasal spray con­tains 6 mg of tetracaine hydrochloride and 0.1 mg of oxym­etazoline hydrochloride. Each sprayer is intended for a single use and is not to be refilled (Hersh et al.2016a,b; Saraghi and Hersh2017).
The sprayers should be stored in the refrigerator at 36–46 °F (2–8 °C) and in a dark place if possible. Devices that have been at room temperature for 5 days should not be used. The device should not be autoclaved, wiped with
Patient position: The patient must be sitting upright for administration
of Kovanaze®.
The patient’s nose should be perfectly clear and free
of mucus.
Application of the first prefilled sprayer. The objective of
this stage is for the solution to reach the inferior meatus.
Positioning the prefilled sprayer. Place the white tip
inside the nostril on the same side as the planned den­tal procedure (ipsilateral):
As parallel as possible to the nasal floor, along the hor-
izontal plane (ala- tragus) at an angle of approximately 90° with respect to the line that joins thenasion and the subnasale (vertical plane) (Figure20.15a).
Parallel toward the septum (midline) of the nasal
cavity (Figure20.15b).
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Cap Finger grip
(a)
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(b)
Remove the cap Spray tip
(c)
Figure20.14 The finger grips and the prefilled sprayer are
separate (a). Snap the finger grip onto the top of the sprayer barrel next to the glass lip (b) and remove the gray cap from the prefilled sprayer (c).  Redrawn, with modifications, from Kovanaze
®
instructions for use.
Kovanaze® must be sprayed rapidly, therefore push
hard and fast on the plunger rod (expel the spray in
0.5
second or less) to create a mist or a plume that can
reach and anesthetize the nerves, and wait 4–5 minutes.
Install finger grip
If patient reports discomfort, administer a third nasal
spray, at the same angle as the second spray (45°) (total
18
mg of tetracaine and 0.3 mg of oxymetazoline), and
wait an additional 10
minutes (total 18–20 minutes).
Note: The third spray is contraindicated in children and adolescents (12–18 years) (total of only 12 mg of tetracaine and 0.2 contraindicated in children weighing less than 40 erally children aged under 12
mg of oxymetazoline). At present, Kovanaze® is
kg (gen-
years).
If the third nasal spray has failed (or the second in chil-
dren and adolescents), we can then use a rescue strategy
based on standard local anesthesia administered via buc-
cal infiltration.
Efficacy ofthe Technique
Clinical success has been evaluated in dental restorative procedures (drilling and filling), where the drill is operated at high speed to penetrate dentin. Table20.9 shows the suc­cess rate to be 85%, although this tends to be greater in inci­sors and canines (95–100%) than in premolars (60–75%) (Ciancio etal.2016; Hersh etal.2016b). However, rigorous assessment with an electric pulp tester shows that pulpal anesthesia is achieved in 30%. This is also higher in the inci­sors and premolars (Capetillo etal.2019). The success of the technique is low in comparison with buccal infiltration with the standard solution of lidocaine 2% with epineph­rine 1:100 000, which has success rates of 90–95% (Capetillo etal.2019; Annex 21). Consequently, the use of this tech­nique is limited in more invasive procedures such as extrac­tions and endodontic dentistry.
Capetillo reported that these poor results could be explained, at least in part, by the fact that the buccal corti­cal plate of the first premolar apices is only 0.7–1.8 mm thick (Capetillo etal.2019). Therefore, during an infiltra­tion, the local anesthetic is delivered very close to the api­ces of the teeth; in contrast, the apices are 8–9 mm from the sinus floor (Jang etal.2017).
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Note: Pushing slowly will create a stream (liquid) and
not a mist.
Application of the second prefilled spray. The objective
here is for the solution to reach the middle meatus. After waiting the necessary time, repeat the maneuver with the other nasal spray, although this time at 45° to the line that joins the nasion with the subnasale (vertical plane) (Figure20.16a,b) and wait an additional 4–5 minutes.
After waiting 8–10 minutes in total, we apply the test
drill into the dentin to ascertain whether the patient responds. If the patient does not respond (no pain), then continue with the procedure.
Complications Specific tothis Technique
Around 70% of patients experience an adverse effect, although, fortunately, these are mild and usually resolve in a few hours (Table20.10). This section is intended to guide dentists with respect to the most important and frequent signs and symptoms (data shown as rounded percentages), as follows:
Local complications: Increased secretion of the nasal mucosa (rhinorrhea)
in 50%. Nasal dryness is rare (5% of cases).
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Appr
ontal plane)
(b)
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382
Nasion
oximately
90°
Septum (midline)
Ver tical plane
Inferior meatus
Tragus
Inferior meatus
Subnasal
(a)
Ala-Tragus plane (Horiz
Figure20.15 Spray position for first spray (approximately horizontal, 90°) (a) and parallel toward the septum (middle) of the nasal
cavity (b). Source: Redrawn, with modifications, from Kovanaze
Nasal congestion in 40% of cases with nasal discomfort,
stuffy nose, sensation of pressure, and even– albeit more rarely– rhinalgia and nose bleed (epistaxis), both in 5% of cases.
Throat irritation in 10% of cases, with itching, numb-
ness, burning sensation, and, more rarely, oropharyn­geal pain.
®
instructions for use.
Increased tearing in 10% of cases. Sneezing in 3%.
Note: Although most of these complications resolve in minutes or hours, some series have shown epistaxis to per­sist for 24–48 hours and rhinorrhea and nasal congestion to last a week (Capetillo etal.2019).
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Nasion
Septum (midline)
Middle meatus
(b)
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Ver tical plane
383
Tragus
Approximately
Middle meatus
Figure20.16 Spray position for second spray (approximately 45°) (a) and parallel toward the septum (midline) of the nasal cavity (b).
 Redrawn, with modifications, from Kovanaze
45°
(a)
Subnasal
®
instructions for use.
Ala-tragus plane (Horizontal plane)
Table20.9 Percentage of clinical success with Kovanaze
restorative procedures in the anterior maxillary teeth.
Reference Sample size Success
Ciancio etal. (2013) 30 83% Ciancio etal. (2016) 44 84% Hersh etal. (2016b) 100 88%
General complications: Headache (cephalea) in 15% of cases. Cardiovascular abnormalities with increased systolic
and diastolic arterial pressure, as well as tachycardia and bradycardia in 5–10% of cases.
®
Rounded 85%
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in
It is interesting to note that, owing to its vasoconstrictive effect, oxymetazoline enhances the anesthetic efficacy of tetracaine but also increases local and general adverse effects (Ciancio et al.2016), probably because of its long half- life (2 hours) (Giannakopoulos etal.2012).
Advantages andDisadvantages
Advantages
1) This system can be used in patients who feel fear or
anxiety associated with intraoral injections and in needle- phobic patients.
2) Elimination of adverse effects associated with injec-
tions. These include hematoma, needle breakage, pares­thesia, and trismus.

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384
Table20.10 Complications specific to this technique (Kovanaze®) as recorded from five clinical trials (percentage of patients
affected).
Giannakopoulos etal. (2012)
N=12 N=30 N=100 N=44 N=50
Patients affected 50% 37% 88% 86% Rhinorrhea 50% 13% 57% 39% 86% Nasal dryness 8% — Nasal congestion 33% 20% 24% 34% 80% Rhinalgia — Epistaxis 17% 3% 6% Throat irritation 8% — Sneezing 3% 4% — Lacrimation 8% 16% — Headache 25% 9% 14% — Arterial hypertension 8% 3% 8% 9% — Tachycardia/bradycardia 8% 16%
The terms used by the authors to define specific signs and symptoms often differ, with the result that there may be a certain degree of overlap and differences in interpretation, for example nasal discomfort, nasal congestion, and sinus congestion (Ciancio etal.2016; Hersh etal.2016b). Similarly, we cannot know whether the same patient presents more than one sign or symptom.
In addition, some signs and symptoms that presented very low frequencies have been eliminated and appear in a single series. Such is the
case, for example, of ringing ear (tinnitus) (Giannakopoulos etal.2012).
5% 7%
Ciancio etal. (2013)
4%
15% 14%
Hersh etal. (2016b)
Ciancio etal. (2016)
Capetillo etal. (2019)
3) The absence of an injection means that there is no risk
of transmitting infections via the blood (e.g. hepatitis B, hepatitis C, and human immunodeficiency virus).
4) This system reduces the risk of accidental needlestick
injuries in clinicians.
Disadvantages
The technique has various disadvantages owing to the characteristics of this new method, as previously seen:
1) The absence of deep pulpal anesthesia. Evaluation with
an electric pulp tester reveals pulpal anesthesia of 30%, which is poor compared with buccal infiltration with the standard solution (Capetillo etal.2019). Consequently, the technique cannot be used in more invasive proce­dures such as oral surgery, extractions, endodontic
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2) The time needed to apply the technique, 10–20 minutes,
plus the time necessary for explanations is longer than the 5 minutes (or little more) necessary for a simple buc­cal infiltration to take effect (Capetillo etal.2019).
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LocalAnesthesiainChildren
389
This short chapter examines the special case of children undergoing dental local anesthesia treatment. For all of the techniques addressed in this book, we have provided data on the methodological and anatomical variations and spe­cific details that must be taken into account when treating children. Here, we bring together the most important aspects of this patient group, even though most have been addressed elsewhere in the book.
TheProblemwithChildren andAdolescents
Control of pain during dental treatment in children and adolescents is essential, not only to be able to carry out the procedure, but also because trauma at this age determines the patient’s attitude to dental treatment in the future. It is in this age group that patients develop high levels of anxiety and phobias that lead them to avoid treatment in the future (McClure 1968; Molin and Seeman 1970; Lautch 1971; Cohen etal.1982; Berggren and Meynert1984; Rankin and Harris1984).
Table21.1 shows that pain is poorly controlled in 15% of children. The problem is even more serious because den­tists tend to think that pain is poorly controlled in fewer cases than actually occurs (Nakai etal.2000). Various cir­cumstances favor failure of dental local anesthesia in chil­dren and adolescents, as follows:
1) Preschool age (<5–6 years) (Wright et al. 1991;
Sharaf1997; Tyrer1999; Lind- Strömberg2001). Children in this age group are unable to understand the need to cooperate with the dentist (Pinkham and Schroeder1975), even though their bones are more porous and thus facili­tate diffusion of the anesthetic solution.
2) High levels of anxiety. Treatment fails in 55% of patients
who experience excess anxiety (Nakai et al. 2000). Remember that seeing the syringe and needle and feel­ing the needle prick are the most anxiety- inducing
aspects of treatment (Lautch 1971; Gale 1972; Meldman 1972; Berggren and Meynert 1984; Scott etal.1984; LeClaire etal.1988).
3) Probability of failure of local anesthesia. This can reach
20% in patients who have previously experienced symp­toms of pain (Nakai etal.2000).
LocalAnestheticSolutions
The most commonly used anesthetic solutions in children and adolescents are as follows:
Standard lidocaine 2% with epinephrine 1:100 000 (10 μg/ml)
000 (12.5 μg/ml) (L- 100 or L- 80) is the solution
or 1:80 most commonly used to achieve pulpal anesthesia in children, both for mandibular block and for maxillary and mandibular buccal infiltration. There are various reasons for this choice:
As children’s bones are smaller and more porous, the
standard solution is very well diffused and successful pulpal anesthesia is achieved.
The standard solution makes it possible to administer
a greater volume of the solution in milliliters depend­ing on the child’s weight, since the maximum limits are greater than with most anesthetic solutions used in dentistry (Annex 10). This makes the approach much safer.
Lidocaine 2% with epinephrine 1:50 000 (20 μg/ml)
(L- 50), which contains twice the amount of epinephrine as the standard solution, is used to complement buccal infiltration of lidocaine 2% with epinephrine 1:100 000 (10
μg/ml) when pulpal anesthesia is not achieved (Gruber1950). It is important to remember the criterion of not mixing two anesthetics at the same site (see Chapter5). In this case, the anesthetic is the same; only the concentration of epinephrine varies. As this is dou­ble and thus more potent, pulpal anesthesia is more effi­cacious (Annex 21).
Local Anesthesia in Dentistry: A Locoregional Approach, First Edition. Jesús Calatayud and Mana Saraghi. © 2024 John Wiley & Sons Ltd. Published 2024 by John Wiley & Sons Ltd. Companion website: www.wiley.com/go/Calatayud/local
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