comparison of the anesthetic efficacy of articaine and mepivacaine in pediatric patients

5
PEDIATRIC DENTISTRY V 34 i NO 1 |AN / FEB llinical Article Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pédiatrie Patients: A Randomized, Double-blind Study Mesut Enes Odabaç. PhD' • Cagdas Çinar, PhD-' • Ceren Deveci, PhD' • Alev Aiaçam, PhD" Abstract: Purpose: The purpose of this study was to evaluate and compare the reaction to pain during local injection and duration of numbness of soft tissue with 4% articaine or 3% mepivacaine in children. Methods: A randomized, double-blind, split-mouth study was used with a sample of 50 7- to 13- year-old children (25 boys and 25 giris: mean age=113 years old) that had similar operative procedure needs in symmetric primary teeth. The modified behavioral pain scale was used for objective evaluation of the children. The sensation after injection and treatment was evaluated using the Wong-Baker FACES pain rating scale. Parents were instructed to ask the child and to record the time when feeling of numbness disappeared. Resuits: The duration of soft tissue was longer for articaine (140.69+49.76 minutes) than for mepivacaine (117.52±42.99 minutes). No difference regarding efficacy of the anesthesia was observed. No statistically significant difference was found in blood pressure, heart rate, or oxygen saturation in all evaluation periods for both solutions. The feeling after treatment was similar for the 2 solutions. Conclusion: Four percent articaine with 1:200,000 and 3% mepivacaine presented the same efficacy, and chiidren displayed the same behavior during injection. (Pediatr Dent 2012:34:42-5) Received Aprii 21, 2010 / Last Revision June 17,2010 I Accepted June 20, 2010 KEYWORDS: ARTICAINE, MEPIVACAINE, CHILDREN, LOCAL ANESTHETIC Child dental anxiety has been a matter of concern for many years. The most anxiety-provoking procedure for children in dentistry is the local anesthetic injection. It is ironic that local anesthetic is both the salvation and the bane of modern den- tistry.' Although dental injection produces pain and anxiety in patients,' local anesthetics are being used during dental treat- ment of children for offering pain-free treatment, children's comfort, and cooperation.' The improvements in agents for local anesthesia are prob- ably the most important advances in dentistry to have occurred in the past 100 years. Various local anesthetic agents have been Lised in dental treatments. Mepivacaine, an amide local anes- thetic, has been widely studied.'"' Three percent mepivaeaine has been fotmd to be equivalent to 2% lidoeaine with 1:100,000 epinephrine for inferior alveolar nerve bloeks.'" Artieaine, a relatively new amide loeal anesthetie, entered elinieal use in 1976 and contains an ester and a thiophene group increasing its liposolubility."' Clinieal studies comparing the success rate of 4% articaine with that of other anesthetic solutions in dentistry give variable results. While, an earlier study reported the infe- riority of 4% articaine in comparison with 2% lidoeaine or 3% mepivacaine in obtaining dental analgesia,'" other clinical studies reported no differences between 4% articaine with 1:100,000 epinephrine and 2% lidoeaine with 1:100,000 epinephrine for anesthesia for general dental proeedures."" 'Drs. Odabaj and 'Deveci are research assistants, 'Dr. Çmar is an asisstant professor, and 'Dr. Alaçam is a professor, all in the Department of Pediatnc Dentistry. Faculty of Dentistry. UniversityofCazi. Ankara. Turkey. Correspond with Dr. Odabu¡at [email protected] Three pereent mepivacaine has been found to be equivalent to other anesthetic solutions for achieving pulpal anesthesia and an inferior alveolar nerve block.^" The use of^ 3% mepivacaine for the intraoral, infraorbital nerve block would be advanta- geous because when medical conditions or drug therapies con- traindicare the use of epinephrine-eontaining formulations, 3% mepivacaine could be used.'^ No study has yet been conducted to assess and compare the responses of children and the duration of numbness of soft tis- sues when receiving local anesthesia with 4% articaine with 1:200,000 and 3% mepivacaine. The aim of this study was to evaluate and compare the reaction of children who received local anesthesia with 4% articaine with 1:200,000 and 3% mepiva- caine and to assess efficacy, the duration of numbness of soft tissues, the time of onset, and children's sensation after treatment. Methods Ilie participants were selected from the patient population in the Department of Pédiatrie Dentistry, Faculty of Dentistry, University of Gazi, Ankara, Turkey. The children were healthy and cooperative. The procedure, possible discomfort, or risks as well as possible benefits were explained fully to parents of the ehildren involved. This study was approved by the Ethics Com- mittee of the Faculty of Dentistry, University of Gazi. A random- ized, double-blind, split-mouth design was used with a sample of 50 7- to 13-year-old children (25 boys and 25 girls; mean age=l 1.3-years-old) that had similar operative procedure needs in symmetric primary teeth. Exclusion criteria were as follows: allergies to local anesthetics or sulfites; history of significant medical conditions; taking any medications that might affect A2 COMPARISON OF ARTICAINE AND MEPIVACAINE IN CHILDREN

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Page 1: Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pediatric Patients

PEDIATRIC DENTISTRY V 34 i NO 1 |AN / FEB

llinical Article

Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pédiatrie Patients:A Randomized, Double-blind StudyMesut Enes Odabaç. PhD' • Cagdas Çinar, PhD-' • Ceren Deveci, PhD' • Alev Aiaçam, PhD"

Abstract: Purpose: The purpose of this study was to evaluate and compare the reaction to pain during local injection and duration of numbness of soft

tissue with 4% articaine or 3% mepivacaine in children. Methods: A randomized, double-blind, split-mouth study was used with a sample of 50 7- to 13-

year-old children (25 boys and 25 giris: mean age=113 years old) that had similar operative procedure needs in symmetric primary teeth. The modified

behavioral pain scale was used for objective evaluation of the children. The sensation after injection and treatment was evaluated using the Wong-Baker

FACES pain rating scale. Parents were instructed to ask the child and to record the time when feeling of numbness disappeared. Resuits: The duration

of soft tissue was longer for articaine (140.69+49.76 minutes) than for mepivacaine (117.52±42.99 minutes). No difference regarding efficacy of the

anesthesia was observed. No statistically significant difference was found in blood pressure, heart rate, or oxygen saturation in all evaluation periods

for both solutions. The feeling after treatment was similar for the 2 solutions. Conclusion: Four percent articaine with 1:200,000 and 3% mepivacaine

presented the same efficacy, and chiidren displayed the same behavior during injection. (Pediatr Dent 2012:34:42-5) Received Aprii 21, 2010 / Last Revision

June 17,2010 I Accepted June 20, 2010

KEYWORDS: ARTICAINE, MEPIVACAINE, CHILDREN, LOCAL ANESTHETIC

Child dental anxiety has been a matter of concern for manyyears. The most anxiety-provoking procedure for children indentistry is the local anesthetic injection. It is ironic that localanesthetic is both the salvation and the bane of modern den-tistry.' Although dental injection produces pain and anxiety inpatients,' local anesthetics are being used during dental treat-ment of children for offering pain-free treatment, children'scomfort, and cooperation.'

The improvements in agents for local anesthesia are prob-ably the most important advances in dentistry to have occurredin the past 100 years. Various local anesthetic agents have beenLised in dental treatments. Mepivacaine, an amide local anes-thetic, has been widely studied.'"' Three percent mepivaeaine hasbeen fotmd to be equivalent to 2% lidoeaine with 1:100,000epinephrine for inferior alveolar nerve bloeks.'" Artieaine, arelatively new amide loeal anesthetie, entered elinieal use in1976 and contains an ester and a thiophene group increasingits liposolubility."' Clinieal studies comparing the success rate of4% articaine with that of other anesthetic solutions in dentistrygive variable results. While, an earlier study reported the infe-riority of 4% articaine in comparison with 2% lidoeaine or 3%mepivacaine in obtaining dental analgesia,'" other clinical studiesreported no differences between 4% articaine with 1:100,000epinephrine and 2% lidoeaine with 1:100,000 epinephrine foranesthesia for general dental proeedures.""

'Drs. Odabaj and 'Deveci are research assistants, 'Dr. Çmar is an asisstant professor,

and 'Dr. Alaçam is a professor, all in the Department of Pediatnc Dentistry. Faculty of

Dentistry. UniversityofCazi. Ankara. Turkey.

Correspond with Dr. Odabu¡at [email protected]

Three pereent mepivacaine has been found to be equivalentto other anesthetic solutions for achieving pulpal anesthesia andan inferior alveolar nerve block.^" The use of 3% mepivacainefor the intraoral, infraorbital nerve block would be advanta-geous because when medical conditions or drug therapies con-traindicare the use of epinephrine-eontaining formulations, 3%mepivacaine could be used.'

No study has yet been conducted to assess and compare theresponses of children and the duration of numbness of soft tis-sues when receiving local anesthesia with 4% articaine with1:200,000 and 3% mepivacaine. The aim of this study was toevaluate and compare the reaction of children who received localanesthesia with 4% articaine with 1:200,000 and 3% mepiva-caine and to assess efficacy, the duration of numbness of softtissues, the time of onset, and children's sensation after treatment.

MethodsIlie participants were selected from the patient population inthe Department of Pédiatrie Dentistry, Faculty of Dentistry,University of Gazi, Ankara, Turkey. The children were healthyand cooperative. The procedure, possible discomfort, or risks aswell as possible benefits were explained fully to parents of theehildren involved. This study was approved by the Ethics Com-mittee of the Faculty of Dentistry, University of Gazi. A random-ized, double-blind, split-mouth design was used with a sampleof 50 7- to 13-year-old children (25 boys and 25 girls; meanage=l 1.3-years-old) that had similar operative procedure needsin symmetric primary teeth. Exclusion criteria were as follows:allergies to local anesthetics or sulfites; history of significantmedical conditions; taking any medications that might affect

A2 COMPARISON OF ARTICAINE AND MEPIVACAINE IN CHILDREN

Page 2: Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pediatric Patients

PEDIATRIC DENTISTRY V 34 / NO 1 JAN / FEB 12

150

Before After first S min after Afterstarting the cartridge cartridge interventionintervention

( 3 )

I Articâine

Mepivacaine

Before After first 5 mm after Afterstarting the cartridge cartridge Intervention (b)intervention

Figure 1. Measurements of systolic (a) and diastolic (b) pressure in different times in patients who received eirher a cartridge ot articaine 4% with 1:200,000

epinephrine or mepivacaine 3% at 2 different appointments. Local anesthetics were used in a double-blind and randomized trial. Data are meantSD (N=50 ) .

anesthetic assessment; and active site of pathosis in the area ofinjection.

For local infiltration anesthesia, in the first appointment,subjects were randomly selected to receive either a cartridge ofArticaine 4% with 1:200,000 epinephrine (Maxicaine, Vem tlaçSan Ve Tic Ltd, Ankara) or mepivacaine 3% (Safecaine, Vemilaç San Ve Tic Ltd). For the second appointment, at least 1week apart from the first appointment, tfie other solution wasadministered.

A standard maxillary infiltration injection was administeredfor primary canine and primary molar with an aspirating sy-ringe and a 27-C 1-inch needle (Hayat Tibbi Aletler, Istanbul,Turkey). Before the injection, topical anesthetic gel on a cottonroll was applied for 1 minute to the injection site. The injectionof the local anesthetic solution was with an average duration of2 minutes (approximately 1 mL/minute).'^

During the injection of local anesthetic solutions, the mo-dified behavioral pain scale suggested by Taddio et al.,'^ wasused for objective evaluation of the children. The scale comprisedthe following parameters: (a) facial display; (b) arm/leg move-ments; (c) torso movements; and (d) crying. The facial displayfollowed Craig's behavioral description of facial actions, whichdescribes pain.' Only 2 of the 4 most descriptive facial actionswere evident (eyebrow bulge or eye squeeze), as the mouth wasopen and the nose was partly covered by the operator's handduring injection. Trained personnel, who were blind to theanesthetic solutions, administered all preinjection and postinjec-tion tests. Blood pressure, pulse rate, and oxygen saturation weretaken before each injection (evaluation 1), before starting the in-tervention (ie, 5 minutes after the injection; evaluation 2), andat 10-minute intervals (evaluation 3 and 4) using pulse oximetry(Datex-Ohmeda TufiSAT, CE Healthcare, Chalfont St. Ciles,UK) and an electronic tensiometer (Braun, Kronberg, Korea).

Immediately after the injections, children were asked tocomplete the Wong-Baker FACES pain rating scale (FBS) forsubjective evaluation of feeling after the injection.'" After verbalinstructions were given on how to use the FBS, the childrenwere asked to select the facial expression that best representedhis/her experience of discomfort. The children were asked torank their sensation immediately after the injection, and byphone 1 and 2 hours after. Parents were instructed to ask thechild and to record the time when feeling of numbness disap-peared and were also asked the occurrence of adverse effects.

Differences in parameters were evaluated by McNemar test andpaired t test. Comparisons were considered significant at P<,Q5.

ResultsNo significant difference between the onset of articaine(60.00±0.00 seconds) and mepivacaine (6O.OO±O.15 seconds)actions was found {P>.Q'b). The duration of soft tissue waslonger for articaine (14O.69±49.76 minutes) than for mepiva-caine (117.52±42.99 minutes). This difference was statisticallysignificant (/'=0.012). Complete anesthesia was achieved all sub-jects for the 2 solutions.

With respect to hemodynamics parameters, there were nostatistically significant differences in blood pressure, heart rate,or oxygen saturation in all evaluation periods for both solutions(Figures 1 to 3, respectively; {P=0.72).

In this study, no significant difference was found in sub-jective evaluation (Wong-Baker FPS) of pain reaction betweenarticaine and mepivacaine for immediately after the injection{P=.O7) and by phone 1 hour (P=.89) and 2 hours after (/^=.77;Table 1). No significant difference was found between the ob-jective evaluation (Taddio's scale) during injection or betweenfirst and second evaluation periods. Subjective pain reaction,measured by the FPS of Wong-Baker, showed that childrenreacted positively to injection with either solution immediately,and 1 and 2 hours after receiving anesthetic solutions, and nosignificant difference was found between solutions in this out-come measure.

100

75

S 50

I Articaine

Mepivacaine

Before After firststarting the cartridgeintervention

5 min after Aftercartridge intervention

Figure 2. Measurements of heart rates in different times in patients who

received either a cartridge of articaine 4% with 1:200,000 epinephrine or

mepivacaine 3% in 2 different appoiniments. Local anesthetics were used

in a double-blind and randomized trial. Dar.i are mean±SD (N=50 ) .

COMPARISON OF ARTICAINE AND MEPIVACAINE IN CHILDREN 43

Page 3: Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pediatric Patients

PEDIATRIC DENTISTRY V 34 i NO 1 JAN I FEB

100

75 I Articalne

Mepivacaine

5C

% O

xyge

1

50

25

0

11Before

starting the

Intervention

11After firstcartridge

11•5 min after

cartridge

11--• ,After

intervention

Figure 3. Measurements of percentage oxygen saturation in différent timesin patients who received either a cartridge of articaine 4% with 1:200,000epinephrine or mepivacaine 3% In 2 different appointments. Local anes-thetics were used in a double-blind and randomized trial. Data aremeantSD (N=50) .

.Me 1. SUBJECTIVE MEASUREMENTS OF REACTION TO PAINFOR ARTICAINE AND MEPIVACAINE

scale (FBS) after injection

Wong-Baker FBS after 1 h

Wong-Baker FBS after 2 hs

Articaine4%

2.32±2.04

O.51±1.14

0.13±0.46

Mepivacaitie3%

1.90±2.24

0.45±0.94

0.16±0.53

/•-value

.07

.89- 7 7

Adverse events related to articaine and mepivacaine weresimilar for the 2 solutions and included accidental lip and/orcheek injury (2 patients) and postprocedural pain (2 patients).The differences between 2 solutions were not statisticallysignificant.

DiscussionIn ihis study, the reaction to pain during local injection andduration of numhness of soft tissue with articaine 4% or mepi-vacaine 3% were assessed and compared. Patients were randomlyselected to receive either a cartridge of articaine or mepivacaine.For the second appointment, the other solution was adminis-tered at least 1 week apart from the first appointment. Nodifference was observed on the second vs the first appointmentregarding the childrens reaction and their self-rating of theinjections.

Our results showed that both agents had the same onsetof action. In this respect, our results with artieaine are in agree-ment with those of Ram and Amir's" study. In their study,they assessed and eompared the reaetion of ehildren to painduring loeal injeetion and the duration of the numbness ofthe soft tissue with lidoeaine 2% with 1:100,000 epinephrineand artieaine 4% with 1: 200,000 epinephrine. ITiey reportedthat articaine provided a longer duration of anesthesia thanlidoeaine in ehildren. They found no signifieant differenee he-tween both .solutions regarding effieaey, although the anesthetiesolutions were of a different eoneentration. Bortoluzzi et al., "eompared the effieaey of articaine 4% with adrenalin 1:100,000

and mepivacaine 2% with adrenalin 1:100,000 in adults. Theyreported articaine 4% was superior to mepivacaine 2% in anes-thesia's depth. Moteover, a fastet time of onset has heen re-ported when articaine 4% was administered in children com-pared to adults.^'

In this study, eardiovaseular parameters analyzed were ar-terial pressure levels, heart rate, and oxygen saturation beforeeaeh injection (evaluation 1), hefore starting the intervention (ie,5 minutes after the injection; reading 2), and at 10-minute inter-vals (evaluation 3 and 4). There were no statistically significantdifferences in blood pressure, heart täte, or oxygen saturationin all reading sessions for hoth solutions. Our results agreewith Colomhini et al.'s^^ study. Similar to our study, they usedthe same local anesthetics, and no statistically significant dil-ferences in blood pressure, heart rate, or oxygen saturation at-tributable to the type of both anesthetic were observed. On theother hand, the comparison of these 2 studies may not be ap-propriate, because the mean age of patients and concentration ofmepivacaine used in this study were different from Colomhiniet al.'s ^ study. There are no clinical studies, howevet, using bothsolutions in children for the purpose of outcome comparison.To the hest of our knowledge, this is the first study comparingthe safety and effieaey of Artieaine 4% with 1:200,000 epine-phrine and mepivaeaine 3% in ehildren.

In this study, we found that the duration of numbness ofsoft tissue was signifieantly longer for artieaine 4% with1:200,000 epinephrine (14O.69±49.76 minutes) than for me-pivaeaine 3% (117.52±42.99 minutes). The presenee of epine-phrine in loeal anesthetie solutions is benefieal regardingduration, depth of anesthesia, blood loss, and teduetion ofsystemie loeal anesthesia toxieity. Vasoeonstrietion, however,also results in soft-tissue anesthesia that lasts several hoursbeyond the time needed for the eompletion of treatment.-' Theptolonged anesthesia is frequently assoeiated with a diminishedahility to perform normal aetivities sueh as speaking, eating,drinking, and smiling. Particulary in children, accidental bitingof the lips or tongue could cause soft tissue injury."' Reducingthe postoperative duration of soft-tissue anesthesia would di-minish these adverse consequences.

The potential risks of vasoconstrictors must be weighedagainst their expected benefits. For adrenergic vasocontrictors(ie, epinephrine), the greatest potential for adverse effects residesin patients with cardiovascular disease, and concerns are alsoexpressed ahout vasoconstrictot usage during pregnancy and inpatients with sulfite intolerance.-''

Conclusions1. The use of 3% mepivaeaine provided a shorter dura-

tion of anesthesia than articaine 4% with 1:200,000epinephrine in children.

2. Both solutions presented the same efficacy, and chil-dren displayed the same behavior during injectionand reported the same feeling after treatment whenreceiving mepivacaine and articaine.

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COMPARISON OF ARTICAINE AND MEPIVACAINE IN CHILDREN

Page 4: Comparison of the Anesthetic Efficacy of Articaine and Mepivacaine in Pediatric Patients

PEDIATRIC DENTISTRY V 34 I NO 1 JAN ' FEB 12

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COMPARISON OF ARTICAINE AND MEPIVACAINE IN CHILDREN 45

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