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blind study of the
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Topical Anesthesia
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Topical or surface anesthetic is applied to the oral mucosa without injection. This is possible because some local anes­thetics have the ability to superficially anesthetize the mucosa. In contrast, the skin is anesthetized poorly because of the barrier effect of the stratum corneum, with only base forms proving somewhat efficacious (Dalili and Adriani 1971). However, non­wounds, abrasions, or burns), as well as the oral mucosa, can be anesthetized with cationic and base forms (Campbell and Adriani1958; Wehner and Hamilton1984).
intact skin (i.e. affected by
Factors Affecting Topical Anesthesia
withLocal Anesthetics
A series of factors affect the efficacy of this approach and must be taken into account.
Local Anesthetic
For a local anesthetic to be effective, it must have a high partition coefficient (highly liposolubility) if it is to act as a clinically useful topical anesthetic (Gangorosa 1981). It must also have higher concentrations than those used in infiltrative techniques. However, the absolute maximum doses are lower. This is because in the 1950s, tetracaine (an ester anesthetic) was very used as a topical anesthetic. The drug was very easily absorbed with higher peak plasma lev­els as compared to peak plasma levels achieved after sub­cutaneous administration (Adriani and Campbell 1956), thus leading to poisoning due to overdose, more frequently when administered topically than parenterally (Adriani and Campbell 1956; Campbell and Adriani 1958). The peaks observed in currently used topical anesthetic prepa­rations are not as high as initially suspected (Table12.1).
The hydrochloride forms (salt) must have an optimal pH of 6.1–6.6, since more acidic levels (pH < 6.1) have the dis­advantage that their efficacy and duration is decreased.
This is because the free base form is better absorbed in the mucosa (Campbell and Adriani 1958), and although acid salt is more stable, it must be alkalinized to become the base form on coming into contact with the mucosa. In addition, the buffering capacity of the mucosa is very lim­ited, in contrast with subcutaneous administration, where tissue fluid is an effective buffer against acids (Campbell and Adriani 1958; Adriani et al. 1964; Adriani and Zepernick1964). Base form preparations have the disad­vantage that they are not very stable and are easily inactivated.
Application Time
Application time is very important because some anesthet­ics or anesthetic formulations require shorter application times to be effective, e.g. benzocaine 20% or lidocaine 5%, both in gel or ointment or paste. Others need longer times, e.g. EMLA 5% cream (eutectic mixture of local anesthetic consisting of 2.5% lidocaine and 2.5% prilocaine) and lido­caine adhesive strips (Dentipatch®) (Annexes 19 and 20).
It is important to remember that the considerable mois­ture of the oral cavity tends to inhibit adhesion to the mucosal surface, therefore maximum absorption is achieved in the first 30 seconds (Carr and Horton 2001a). Furthermore, the longer the anesthetic remains in contact with the mucosa, the better it will penetrate (Meechan2000).
Method ofApplication
As mentioned above, the high degree of moisture in the mouth disperses topical local anesthetics easily by diluting them in saliva and preventing them from reaching suitable concentrations at a specific site, thus causing them to lose their efficacy (Carr and Horton 2001a). Formulations in solution, i.e. liquids, are those that most easily disperse in the mouth, with the result that they lose much of their effi­cacy and are more likely to fail (Annex 19) and anesthetize
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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Table12.1 Peak blood levels after administration oftopical anesthetic tothe oral mucosa.
Anesthetic administered Peak
Commercial formulation Amount (mg) Anesthetic
Lidocaine 10% aerosol
Lidocaine patch 50 Lidocaine 50 30 95 45 Brook (1989) Dentipatch 20% 46 Lidocaine 46 2.5–15 22 15 Hersh (1996) Dentipatch 20% 46 Lidocaine 46 5–15 22.5 45 Houpt (1997) Dentipatch 20% 46 Lidocaine 46 5 64 10 Leopold (2002) EMLA 5% cream 4000 Lidocaine
EMLA 5% cream 4000 Lidocaine
EMLA 5% cream 8000 Lidocaine
Oraqix 5% 3500 Lidocaine
Oraqix 5% 2000 Lidocaine
Oraqix 5% 8500 Lidocaine
The dose becomes toxic from 5 μg/ml (= 5000 ng/ml) in the case of lidocaine and from 4 μg/ml (= 4000 ng/ml) in the case of prilocaine (Annex13).
2000 Lidocaine 200 4 350 30 Haasio (1990)
Prilocaine
Prilocaine
Prilocaine
Prilocaine
Prilocaine
Prilocaine
Amount (mg) Time (min)
100 100
100 100
200 200
175 175
50 50
212.5
212.5
4 200
5 210
30 221
20–27 99–266
6–9 172
6 280
Concentration (ng/ml) Time (min) Reference
100
50
131
46–118
76
110
5 15
30 30
40 40
20–40 20–40
30 30
189 189
Haasio (1990)
Pere (1992)
Vickers (1997)
Huledal and Friskopp (2000)
Friskopp and Huledal (2001)
Herdevall (2003)
distal parts of the mouth such as the pharynx, thus ham­pering swallowing (Haasio etal.1990). They can also cause a bad taste, which often leads to increased salivation to counter it, thus further increasing dilution and reducing efficacy (Evers and Haegerstam1981).
Aerosol formulations are subject to the same problems as liquid formulations. In addition, the doses administered are difficult to control (Campbell and Adriani 1958) and the drug is sometimes inhaled on application (Roberts andSowray1987). Aerosols are not recommended in chil­dren because the noise they make and their bad taste (which spreads through the mouth) can lead to uncontrollable bad behavior (Frasier1967; Evers and Haegerstam1981).
We can therefore deduce that topical anesthetics in a liq-
uid formulation and aerosol should not be recommended owing to their low efficacy (Annex 19) and the abovemen-
tioned problems, therefore gel, ointment, cream, and paste formulations are preferred.
Amount Administered
The amount may have some impact, although we do not know the optimal amounts to ensure maximum efficacy.
It is important to distinguish between the amount of formulation and the amount of anesthetic, for example 100
mg of benzocaine 20% in cream =20 mg of benzo-
caine and 1
g of lidocaine (1000 mg) 5% in gel=50 mg of
lidocaine.
We must remember that in many cases, anesthetic is
also administered by injection and that this amount must be added to the amount of the topical agent to avoid prob­lems with toxicity due to excessive dosing (Cannel 1996;
Meechan etal.1998). If a patient were to receive the max­imum recommended dose of a topical anesthetic, the patient could not receive any other topical or injected local anesthetic.
Types ofPain
Some clinical trials have shown that needle prick is a painful stimulus that can be anesthetized better than contact with bone or an injection (Annex 19). In addi­tion, electrical stimuli or pressure can be more intense and therefore more useful for evaluating the efficacy of topical anesthesia (Adriani et al. 1964; Adriani and Zepernick1964).
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Area ofthe Mouth
Topical anesthesia is not as effective in all areas of the mouth. The mucosa and the buccal, maxillary, and man- dibular gingiva are anesthetized easier than the palate, as shown in clinical trials (Annex 19). This observation is logical, given that the palatal mucosa is much thicker and keratinized, therefore its permeability is lower than in any other part of the oral mucosa (Lesch etal.1989). Furthermore, as it has less subcutaneous tissue, the fibromucosa, which is formed by denser fibers, adheres tightly to the periosteum, thus leading to a more painful injection resulting from stretching of the tissue (Gill and Orr II 1979; Keller 1985; Kreider et al. 2001; Bhalla etal.2009).
Topical anesthesia is not effective at reducing the discom-
fort or pain caused by mandibular block (Annex 19), since
the needle penetrates about 20–25 mm into the ptery­gomandibular space and topical anesthetic cannot reach this depth (Meechan etal.1998).
Effect ofTopical Anesthesia
Topical anesthesia has a series of effects, which can be summarized as follows:
1) Anesthesia of the fibromucosa is the main function,
since it penetrates 1–3 nerve endings can detect pain. In infiltrative techniques, penetration of the needle into the subcutaneous tissues and muscle fascia by a few millimeters is less painful because sensitivity to pain is reduced at this level (Meadows1970).
2) It has an important placebo effect that boosts the
action of the anesthetic and calms the patient (Kincheloe et al. 1991; Martin et al. 1994; Roghani etal.1999), therefore it is very important to inform the patient that you are going to use topical anesthesia before the injection in order to reduce the pain (Martin etal.1994).
3) Anesthetic solutions containing disinfectant can also
help to disinfect the surface of the mucosa (Winther and Khan 1971). Topical anesthetics (lidocaine, tet­racaine, cocaine, EMLA), in addition to their anes­thetic properties, also possess antimicrobial effects (Mullin and Rubinfeld1997; Aldous etal.1998; Aydin et al. 2001; Berg et al. 2006; Gocmen et al. 2008; Reynolds etal.2016), but the rate of onset of antimi­crobial activity as well as whether the activity is bactericidal or bacteriostatic is still unknown (Kaewjiaranai etal.2018).
mm, at which point most of the
Topical Anesthetics inDentistry
Below, we set out the topical anesthetics that are currently used in dentistry. However, it is clear that the most widely used are benzocaine 20% and lidocaine 5%, both of which can be applied in ointment or gel.
Benzocaine
Benzocaine, or ethyl aminobenzoate, is an ester- type anesthetic that was synthesized by Eduard Ritser (1859–1946) in 1890 and initially called Anesthesin (Neue Arzneimittel und pharmaceutische Spezialitäten1902). It has been used exclusively as a topical anesthetic since 1903 (Sveen et al. 1982). Since benzocaine lacks the hydrophilic cationic amino terminus (Ritchie and Ritchie1968; de Jong1977), it is practically free of any charge, and is only a neutral free base (pKa 3.2) at physi­ological pH. It is therefore not water soluble (Adriani and Campbell 1956; Anonymous 1964; Takman 1975; de Jong1977) and its action is pH- independent (Ritchie and Ritchie1968) and very fast. As very little is absorbed, ben­zocaine scarcely causes toxic systemic reactions (it is con­sidered to be very safe) (Adriani and Campbell1956) and cannot be injected because it is very irritant and is only used as a topical anesthetic. Table 12.2 summarizes its main characteristics.
Maximum Dose
While no official dose has been established by the United States Food and Drug Administration (US FDA) (Beutlich1991; American Dental Association2003), some researchers, based on cases of toxic methemoglobinemia, have estimated that it is not recommended to exceed
mg/kg (Potter and Hillman 1979; Rodriguez
15–25 et al. 1994). This criterion is followed by a number of authors (Klein et al. 1983; Severinghaus et al. 1991; Wilburn­absolute maximum dose in a 70- kg adult could be set at 1050 mg (15 mg/kg), which, at 20%, represents 5.5 ml of gel or ointment. Figure12.1 shows different doses in gel for use in dentistry.
Advantages andDisadvantages
The main advantages of benzocaine are that its action is very quick, 20–30 oral mucosa better than EMLA cream, and its taste is more agreeable than that of EMLA (Tulga and Mutlu 1999; Primosch and Rolland­ Al- Melh etal. 2005). In addition, it is almost not absorbed because it is not water- soluble (see above), therefore it is considered safe.
Goo and Lloyd1999). Therefore, as a guide, the
seconds, it is cheap, it adheres to the
Assensi 2001;
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Topical Anesthesia
5
H
Benzocaine
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Table12.2 Benzocaine.
Pharmacological factors Reference
● Name and synonyms: benzocaine, Anesthesin, Americaine
● First synthetized in 1890 by Eduard Ritsert Neue Arzneimittel und pharmaceutische
● Chemical name: Ethyl aminobenzoate Anonymous (1964)
● Formula: C
9H11NO2
Spezialitäten (1902)
N
2
Molecular weight: Base 165.2
COO–C2H
Martindale (1982)
Hydrochloride
Physicochemical properties
● pKa value or dissociation constant: 3.2 Annex 6
● Lipid solubility or partition coefficient: N- heptane 3.1
Annex 7
n-octanol 80
Indicating capacity for topical anesthesia
● Binding to plasma proteins: ?
● Vasodilation:?
Clinical factors
● Relative anesthetic potency: 1
● Relative toxicity: ?
● Absolute maximum dose in dentistry: 1050 mg (15 mg/kg)
This is only a guide. Equivalent to 5.5
● Use during pregnancy: Yes (FDA category=C)
ml of gel or ointment at 20%
Indicating that it is safe
● Use during breastfeeding: Yes (indicating that it is safe) Haas (2000)
Potter and Hillman (1979)Rodriguez (1994)
Haas (2000) (Table5.11)
Singh and Al (2019)
● Use in children: Yes (indicating that it is safe)
Contraindicated in children aged under 2
years
Singh and Al (2019)
Clinical efficacy (mouth)
Benzocaine 20% in gel, ointment, or paste
● Onset of action: 20–30 s (veryfast) Annex 20
● Maximum effect: ?
● Duration of effect of topical anesthesia: 5 min
Main pharmacological factors, physicochemical properties, clinical factors, and clinical efficacy. Benzocaine has a pKa=3.2 because it lacks the hydrophilic N- terminus, therefore it is not absorbed (safer than topical anesthetic). It is very irritating when injected. In addition, pharmacokinetic data (clearance, volume of distribution, and plasma half- life) are lacking. Similarly, it does not bind to plasma proteins.
Its main disadvantages are the short duration of the anesthetic effect (5 minutes) and its low potency, although it is better than placebo (Annex 19).
Specific Adverse Effects
There are two specific adverse effects: sensitization and aller­gic reactions, which can appear in 3–6% of cases owing to
continued exposure (Martindale 1982) and which occur as cross- reactions with sulfonamide allergy (Anonymous1964).
Benzocaine can also lead to toxic methemoglobinemia when administered at doses greater than the recommended dose, especially in children aged under 1 year owing to the immaturity of their enzyme system (Anonymous 1964; Rodriguez et al. 1994) (see Chapter 23). In a few
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0.1 mL
0.2 mL
0.3 mL
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20 mg
Figure12.1 Example of different amounts and doses of topical
anesthetic benzocaine 20% gel on a cotton swab. Redrawn from Künisch etal. (2017).
40 mg
60 mg
susceptible individuals, there is no “therapeutic window” between the doses required to produce a therapeutic effect and that producing toxic methemoglobinemia (Guay2009). Benzocaine is contraindicated in patients with history of methemoglobinemia and should not be used in children younger than 2
years old (American Academy of Pediatric
Dentistry2020).
Lidocaine
Lidocaine is an amide- type anesthetic that can be injected and applied topically. It is one of the most commonly used anes­thetics throughout the world in both of its formulations. Its main pharmacological factors, physicochemical properties, and clinical factors were discussed in Chapter7 (Table7.2).
In this section, we examine the gel, ointment, and paste 5% formulations because the liquid and aerosol formula­tions are very poor (see Annex 19).
Maximum Dose
The absolute maximum dose for a ≥70- kg adult has been set at 250 Association2003) (3.6 is equivalent to 5
mg (Adriani et al. 1964; American Dental
mg/kg), which in gel or ointment 5%
ml. The maximum dose for topical anes­thetic is lower than the maximum dose for injectable solu­tion (300
mg) (Table7.2, Chapter7).
Advantages andDisadvantages
The main advantages are that onset is rapid, the drug is inexpensive, and its action lasts longer than that of benzo­caine (12 minutes) (Annex 20) (Table12.3).
Specific Adverse Effects
The main adverse effect is that of toxicity due to overdos­ing, therefore the recommended maximum dose should not be exceeded. In addition, some formulations of lido­caine contain methylparaben as a preservative, which can cause allergic sensitization (see Chapters7 and23).
Lidocaine Adhesive Patches (DentiPatch®)
These patches measure 8 × 26 × 2 or 10 × 20 × 2 mm in a bio­adhesive matrix that is stuck directly onto the oral mucosa (Houpt et al. 1997; Kreider et al.2001; Carr and Horton 2001b; Stecker etal. 2002). The patches contain lidocaine 20%, which is equivalent to 46 mg per patch (Stecker etal.2002). This method enables the anesthetic to spread in the mucosa without becoming diluted in the mouth or dis­persing in the saliva owing to the fact that it is confined to the mouth. Consequently, the patch has an advantage over gels, ointments, creams, liquid solutions, and aerosols.
The patch formulation was approved by the US FDA in 1996 (Hersh et al. 1996; Houpt et al. 1997), although the first study with adhesive strips appeared in 1968 (Giddon etal.1968).
Maximum Dose
As we have already seen, the absolute maximum dose for lidocaine as a topical anesthetic for a ≥70- set at 250 Association 2003) (3.6 patches with 46
mg (Adriani et al. 1964; American Dental
mg/kg), which in 20% lidocaine
mg per patch represents a maximum of
kg adult has been
5.5patches.
Advantages andDisadvantages
Lidocaine adhesive strips have several advantages. They pre­vent spread of the anesthetic in the mouth, as they are con­fined (Howitt and Lowell1972; Hersh etal.1996), therefore the anesthetic does not spread and anesthetize the tongue or pharynx (Nakamura et al.2013). The dose administered is well controlled and the anesthetized area is easily seen (Howitt and Lowell1972). In addition, as the patch has a relatively potent effect (Table12.4), the dental hygienist can use it for dental procedures such as scaling and root planing
Table12.3 Lidocaine.
Clinical efficacy (mouth) Reference
● Onset of action: 1–2 min Annexes 19 and 20
● Maximum effect: 5 min
● Duration of the effect of topical
anesthesia: 12 min
5% formulation in gel, ointment, or paste.
Table12.4 Lidocaine.
Clinical efficacy (mouth) Reference
● Onset of action: 2–5 min Annexes 19 and 20
● Maximum effect: 15 min
● Duration of the effect of topical
anesthetic: 25 min
Adhesive strips or patches (DentiPatch).
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Topical Anesthesia
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200
(Carr and Horton2001b) or to fit the clamps for rubber dams (Stecker etal.2002) and the dentist can take small superficial biopsy specimens (Roller and Ship1975).
The disadvantages are that onset of action is slow, 2–5
min­utes, and it is four times more expensive than benzocaine (Stecker etal.2002). Occasionally, adhesion fails owing to a fault in the system (Stecker etal.2002), insufficient depth of the buccal area, and excessively viscous saliva (Taware etal.1997). Of note, it has not been declared safe in patients aged under 12
Specific Adverse Effects
years (American Dental Association2003).
Specific adverse effects include mild irritation of the mucosa the patch adheres to in 10–20% of cases owing to the long periods of time it remains in the same place (Brook et al. 1989; Hersh et al. 1996; Houpt et al. 1997), its unpleasant – generally bitter – taste (Brook et al.1989; Houpt et al.1997; Taware etal.1997), and the fact that it sometimes increases salivation and the sensation of retch­ing or nausea (Stern and Giddon1975).
EMLA Cream
EMLA (Eutectic Mixture of Local Anesthetic). Eutexia is a physical phenomenon by which the mixture of two cor­rectly dosed substances has a lower melting point than either of the two separately or mixed at any other propor­tion. In this case, the two substances are the anesthetics lidocaine and prilocaine.
The mixture was first proven to be effective on the skin in 1980 (Juhlin etal.1980). In 1981, the patent was registered in Europe (Broberg and Evers1981). The FDA authorized the drug in the United States in 1993 (Primosch and Rolland-
Assensi 2001). Currently, the manufacturer (Astra) and the FDA do not recommend application of EMLA on the oral mucosa (Oraqix®, an oral variant is rec­ommended [see below]), restricting it to the skin, since the safe doses remain unknown (Primosch and Rolland­Assensi 2001; Lim and Julliard 2004; Al- Melh and Anderson 2007; Franz- Montan et al. 2008). However, EMLA cream has been used in dentistry in clinical trials, from which we provide data.
Advantages of the Structure and Composition of EMLA
The oil–water emulsion of lidocaine normally forms drops with an anesthetic concentration of 20% (Reiz and Reiz1982). In addition, lidocaine and prilocaine have melt­ing points of 96 and 37 °C, respectively (Vickers and Punnia- Moorthy 1993; Munshi et al. 2001). When lido­caine and prilocaine are mixed 1:1 in an oil–water emul­sion with ester ethoxylate surfactant of neutralized fatty acids such as Carboner 934P, the resulting emulsion does
not contain lipophilic solvent (Nyqvist- Mayer etal.1986), and a cream is obtained with the following characteristics:
1) Emulsion drops with a high concentration of anesthetic
(80%) (Juhlin et al. 1980; Reiz and Reiz 1982) and a lower size (1
μ) (Nyqvist- Mayer etal. 1986).
2) The melting point of both anesthetics falls to 18 °C
(Brodin et al. 1984), that is lower than for each sepa­rately. The mixture behaves as a pure solid (eutectic), thus enabling it to be absorbed at body temperature.
3) The high water concentration facilitates penetration via
the skin and mucosa.
In theory, the above- mentioned factors make it possible to create a more powerful anesthetic compound than each separately at the same concentration. The complete com­position of EMLA is set out in Table12.5.
Maximum Dose
There is no established maximum dose, although the results from a clinical trial showed that it was possible to administer 8000 mg of EMLA 5% cream (400 mg of local anesthetic: 200
mg of lidocaine and 200 mg of prilocaine) with no risk of toxicity, since it generated peak levels that were far from toxic (Vickers et al. 1997) (Table12.1). In addition, Oraqix (variant of EMLA cream [see below]) has an established maximum dose of 8500 mg (Herdevall etal.2003).
In conclusion, we can propose an absolute maximum dose for a ≥70- kg adult of 8000 mg (115 mg/kg), which is equivalent to 5.7 caine and 2.85
Advantages andDisadvantages
mg/kg of anesthesia (2.85 mg/kg of lido-
mg/kg of prilocaine).
The main advantage is that it makes it possible to achieve a relatively potent anesthetic effect, therefore the dental hygienist can carry out small dental tasks such as scaling and root planing or measuring periodontal pocket depth
Table12.5 Composition per 1 ml=1 g=1000 mg ofEMLA 5%
cream.
Component Function Milligrams (mmol/l)
Lidocaine Local anesthetic 25 (107) Prilocaine Local anesthetic 25 (117) Arlatone 289 Surfactant/emulsifier 19 Carbopol 934 Thickener 10 Sodium hydroxide Up to pH=9.6 — Purified water Up to 1 ml ± 921
Arlatone 289 is hydrogenated and ethoxylated castor oil. Carbopol 934 or Carbomer 934P is carboxypolymethylene. Source: Data from Reiz and Reiz (1982), Nyqvist- Mayer etal. (1986), Engberg (1987), Haasio (1990), Munshi etal. (2001).
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Table12.6 EMLA.
Clinical efficacy (mouth) Reference
● Onset of action: 3 min (2–5) Annexes 19 and 20
● Maximum effect: 5 min
● Duration of the effect of
topical anesthetic: 20
5% cream.
min
(Donaldson and Meechan1995) and removing orthodontic arch bars (Pere et al.1992). In addition, the dentist can remove small fibromas from the palate (Meechan2001). Table12.6 shows data on their clinical efficacy.
The disadvantages include the slow onset of action
minutes, mean 3 minutes), the fact that it is more
(2–5 expensive than benzocaine (Meechan and Donaldson
1994), and the low viscosity of EMLA cream (Meechan and Donaldson 1994; Donaldson and Meechan1995; Tulga and Mutlu1999; Primosch and Rolland- Assensi2001), which reduces its power of absorption through dispersion in the mouth and dilution in saliva, and means that a large amount of cream remains on the cotton swab or roll (Holst and Evers 1985; Lim and Julliard2004). EMLA cream is not recommended in children owing to the lack of data or for application in the oral cavity in adults. However, we do have an equivalent for oral use, namely, Oraqix (see below).
Specific Adverse Effects
A burning sensation occurs in the oral mucosa after long applications (30–40
minutes) (Vickers and Punnia­Moorthy1993; Franz- Montan etal.2008) owing to the high pH (9.6) (Vickers and Punnia-
Moorthy 1993) and, very rarely, ulcers on the superficial mucosa for the same reason (Franz-
Montan etal.2008). Patients also complain of the bitter taste (Svensson and Petersen 1992; Meechan and Donaldson 1994; Tulga and Mutlu 1999; Primosch and Rolland-
Assensi2001). Prilocaine can induce toxic methe­moglobinemia in children aged under 6 years (Frayling etal.1990). This is also the case for children aged under 1 year (Engberg etal.1987), whose enzymes are not suffi­ciently mature to metabolize high doses of EMLA (see Chapter23).
Tetracaine (Amethocaine)
Tetracaine is an ester- type anesthetic that was first synthe­sized in 1928 by the German chemist Otto Eisleb (1887–1948) in IG Farben (Hoechst). It was patented in the United States in 1932 (Eisleb 1932) and marketed under the name of Pantocaine (Eisleb1934).
Tetracaine is known as Amethocaine in the British phar­macopeia. As it has a pKa of 8.5, onset of action can some­times be delayed. In addition, as with lidocaine, it is one of the few local anesthetics that is achiral, that it, it does not have optic isomers (Calvey1995). The main characteristics of tetracaine are summarized in Table12.7.
Maximum Dose
Tetracaine is an old topical anesthetic, which, when applied to the mucosa, is absorbed rapidly owing to its potent vaso­dilator effect. The resulting anesthesia is deeper and more potent, although there is also a greater risk of the drug passing to the bloodstream (Bonica 1950; Adriani and Campbell1956). Given that the maximum dose as a topical anesthetic has been set at 20
mg (Carabelli1952; American Dental Association2003), the absolute maximum dose in a ≥70-
kg adult is 20 mg (0.3 mg/kg), which is equivalent to mg (= 2 ml) in 1% creams.
2000
When tetracaine is applied as an aerosol, it is easy to lose control of the dose administered, therefore it is recom­mended not to apply the drug for more than 1–2
seconds to avoid administering a toxic dose or, preferably, the drug should be administered using a fixed- dose applicator so as not to exceed the maximum dose.
Advantages andDisadvantages
The main advantage of tetracaine is that it is a potent topi­cal anesthetic, as seen in its clinical effect in 1% formula­tions, which lasts 50 minutes (Table 12.7). Its main disadvantage is the ease with which it produces toxic reac­tions when absorbed after application on the mucosa and the dose is greater than de 20
mg (Weisel and Tella1951;
Carabelli1952).
Specific Adverse Effects
Key adverse effects include allergic and hypersensitivity reactions caused by the fact that tetracaine is an ester anesthetic. The other main problem is toxic reactions resulting from overdose when the drug is applied to the mucosa (it is barely absorbed by intact skin; Mazumdar et al. 1991). Tetracaine is a topical anesthetic that not only anesthetizes the surface but also reaches a certain depth. Consequently, its potent vasodilator effect passes to the systemic circulation in such a way that it is the only anesthetic that can reach higher levels in blood after topical application on the mucosa than after parenteral injection (Adriani and Campbell1956). In the 1940s and 1950s, tetracaine was the anesthetic that caused the high­est number of toxic reactions when the doses adminis­tered were greater than 30–40 mg (Weisel and Tella1951; Carabelli 1952; Adriani and Campbell 1956) (see Chapter23).
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