Consort Randomized Clinical Trial

Effect of Topical Anesthesia on Pain from Needle

Insertion and Injection and Its Relationship with
Anxiety in Patients Awaiting Apical Surgery:
A Randomized Double-blind Clinical Trial
Sin-Yeon Cho, DDS, PhD,* Euiseong Kim, DDS, MSD, PhD,† Sung-Ho Park, DDS, MSD, PhD,†
Byoung-Duck Roh, DDS, MSD, PhD,† Chan-Young Lee, DDS, MSD, PhD,† Seung-Jong Lee, DDS, MS,†
and Il-Young Jung, DDS, MSD, PhD†

Abstract
Introduction: We aimed to simultaneously investigate Key Words
the effects of topical anesthesia on needle insertion Anxiety, maxillary central incisors, pain, topical anesthesia
and injection pain in the labial mucosa of the maxillary
central incisors of patients awaiting apical surgery and
to assess the relationship between patients’ anxiety
and pain scores. Methods: Forty-four patients sched-
P ain from dental injec-
tions is 1 of the greatest
sources of patient dental
Significance
Topical anesthesia showed significant effects on
uled for apical surgery of the maxillary anterior incisor reducing both the pain of insertion and injection
anxiety (1); thus, dentists
or canine were included, and all completed the Modified during infiltration anesthesia in maxillary central in-
should seek to perform
Dental Anxiety Scale (MDAS) questionnaire. One piece cisors. The extent of pain reduction from topical
painless injections when-
of Xylocaine (AstraZeneca, Sodertalje, Sweden) gauze anesthetic application was greater in highly
ever possible. Although
was applied to the right or left side of the labial vestibule anxious patients than nonanxious patients.
topical anesthetics are
below the central incisor according to a randomization often administered for in-
process, and 1 piece of water gauze was applied to jections, the results of investigations evaluating their effectiveness have varied (2–7).
the contralateral side of the labial vestibule. Each piece There has also been a range of opinions on the effectiveness of topical anesthetics
of gauze remained in place for 2 minutes. The subjects among dentists (8). Consequently, more detailed research is needed to determine
were asked to rate their pain according to the numeric the efficacy of topical anesthesia.
rating scale immediately after needle insertion and Previous studies have typically included healthy volunteers to measure pain levels
anesthetic solution injection. Results: Topical during injections, and the study designs have included tests at 2 visits for both the exper-
anesthetic application significantly reduced both imental and the control group (2, 3). During experimental dental injections, healthy
insertion- and injection-related pain. Injection pain volunteers experience different conditions than that of real patients awaiting
was significantly higher than insertion pain throughout treatment. Actual patients may express a more realistic reaction to painful stimuli
the experiment. The difference in pain scores between than volunteers (9–11). Patient responses to the same stimulus can also vary with
the placebo and topical anesthetic groups was signifi- time. Furthermore, pain scoring systems are subjective and not well standardized
cantly greater for insertion pain than injection pain. with time. Their results may be skewed if the experimental and control tests are
The group with higher MDAS scores showed signifi- performed on different days.
cantly higher pain scores, except for insertion pain re- Anxiety is a normal reaction to stress. Patients who report pain often show high
ported by the topical anesthetic group, which did not levels of anxiety; therefore, treating this anxiety can decrease their pain (12). Dental
show a significant difference between MDAS score anxiety is widespread and can negatively influence patients’ lives by causing them to
groups. Conclusions: The topical anesthetic was highly avoid or delay dental treatment (13). By evaluating the dental anxiety of real patients
effective for both insertion and injection pain during and investigating the relationship between their dental anxiety and pain scores during
infiltration anesthesia in the maxillary central incisors. dental injections and the administration of topical anesthesia, dentists may better treat
Highly anxious patients reported higher pain scores; anxious patients.
however, topical anesthetics reduced the effect of anx- Accordingly, this study had 2 aims. The first aim was to simultaneously investigate
iety on increasing pain. (J Endod 2016;-:1–6) the effects of topical anesthesia on needle insertion and injection pain in the labial

From the *Department of Dentistry and Institute for Translational and Clinical Research, International St. Mary’s Hospital, Catholic Kwandong University, Incheon;
and †Microscope Center, Department of Conservative Dentistry and Oral Science Research Center, College of Dentistry, Yonsei University, Seoul, Korea.
Address requests for reprints to Dr Il-Young Jung, Microscope Center, Department of Conservative Dentistry and Oral Science Research Center, College of Dentistry,
Yonsei University, 250 Seongsanno, Sudaemun-Gu, Seoul 120-752, Korea. E-mail address: [email protected]
0099-2399/$ - see front matter
Copyright ª 2016 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2016.10.036

JOE — Volume -, Number -, - 2016 Pain from Needle Insertion and Injection 1
Consort Randomized Clinical Trial
mucosa of maxillary central incisors in real patients. The second aim (a = 0.05) to detect a 20% decrease in self-rated pain using G power
was to assess the relationship between patients’ anxiety and pain scores 3 software (Franz Faul, University of Kiel, Germany).
during dental injections and topical anesthesia administration.
Subjects
The subjects included patients who were scheduled to receive api-
Material and Methods cal surgery on their maxillary anterior incisors or canines at the Depart-
This study was approved by the institutional review board of Yonsei ment of Conservative Dentistry, College of Dentistry, Yonsei University,
University Dental Hospital, Seoul, Korea (2-2013-0032). Written Seoul, Korea, between November 2013 and January 2015 and were
informed consent was obtained from each subject after the nature of also receiving infiltration anesthesia on the right and left side of the
the procedures and the risks had been explained. This study was de- maxillary anterior labial mucosa for flap reflection. All subjects were
signed as a double-blind randomized controlled clinical trial. A sample in good health (American Society of Anesthesiologists classification of
size of 44 was calculated to be sufficient to provide 90% power I and II), over 19 years of age, and could understand and correctly

CAN YOU TELL US HOW ANXIOUS YOU GET, IF AT ALL,

WITH YOUR DENTAL VISIT?

PLEASE INDICATE BY INSERTING ‘X’ IN THE APPROPRIATE BOX

1. If you went to your Dentist for TREATMENT TOMORROW, how would you feel?

Not Slightly Fairly Very Extremely

Anxious ! Anxious ! Anxious ! Anxious ! Anxious !

2. If you were sitting in the WAITING ROOM (waiting for treatment), how would you feel?

Not Slightly Fairly Very Extremely

Anxious ! Anxious ! Anxious ! Anxious ! Anxious !

3. If you were about to have a TOOTH DRILLED, how would you feel?

Not Slightly Fairly Very Extremely

Anxious ! Anxious ! Anxious ! Anxious ! Anxious !

4. If you were about to have your TEETH SCALED AND POLISHED, how would you feel?

Not Slightly Fairly Very Extremely

Anxious ! Anxious ! Anxious ! Anxious ! Anxious !

5. If you were about to have a LOCAL ANAESTHETIC INJECTION in your gum, above
an upper back tooth, how would you feel?

Not Slightly Fairly Very Extremely

Anxious ! Anxious ! Anxious ! Anxious ! Anxious !

_________________________________________________________________
Instructions for scoring (remove this section below before copying for use with patients)

The Modified Dental Anxiety Scale. Each item scored as follows:

Not anxious = 1
Slightly anxious = 2
Fairly anxious = 3
Very anxious = 4
Extremely anxious = 5

Total score is a sum of all five items, range 5 to 25: Cut off is 19 or above which
indicates a highly dentally anxious patient, possibly dentally phobic

Figure 1. MDAS questionnaire.

2 Cho et al. JOE — Volume -, Number -, - 2016

 Consort Randomized Clinical Trial
TABLE 1. Comparison of Numeric Rating Scale Pain Scores between the Surgical Site and the Contralateral Site
Insertion Injection
Solution Site n Mean Standard deviation Significance Mean Standard deviation Significance
Placebo Surgical 18 2.11 1.410 .461 3.06 1.955 .893
Contralateral 26 2.50 1.881 2.96 2.457
Topical anesthetic Surgical 26 0.35 0.629 .452 1.58 1.206 .363
Contralateral 18 0.50 0.707 1.94 1.434

express the numeric rating scale (NRS) pain score. Prospective subjects surgery was subsequently resumed on both the labial side and the
were excluded if they reported different responses to palpation on the palatal side.
right and left injection sites of the labial mucosa or if there was a sinus
tract within a centimeter of the injection site.
Analysis
Independent t tests were used for analysis in the following 4 con-
Procedure ditions: to compare the means of the NRS pain scores between the sur-
All subjects were instructed on how and when to rate their NRS gical site (site of the tooth planned for apical surgery) and the
pain scores, and they each completed the Modified Dental Anxiety contralateral site, to compare patients with lower MDAS scores and
Scale (MDAS) questionnaire (14) (Fig. 1). Two paper cups, 3 pieces those with higher MDAS scores, and to compare males and females
of gauze (2 ! 2 inch), topical anesthetic spray (Xylocaine 10% and patients under 40 of years and those over 40. The average MDAS
pump spray; AstraZeneca, Sodertalje, Sweden), and a tap water spray score of 12.0 was used as the standard to dichotomize the patients
were prepared. Two pieces of gauze were placed in the first paper into 2 groups with lower and higher MDAS scores.
cup, and each piece received 5 sprays of Xylocaine (50 mg Xylo- A comparison of the NRS pain scores between the placebo and the
caine). The other piece of gauze was inserted into the second paper topical anesthesia groups was conducted with a paired t test. The differ-
cup and was sprayed with tap water with the equivalent amount of 5 ence in NRS pain scores at needle insertion and at anesthetic solution
sprays of Xylocaine. After the 2 pieces of Xylocaine gauze and the 1 injection was also analyzed with a paired t test. The effect of order of
piece of water gauze had been prepared, an assistant doctor obtained insertion and injection between the right site and the left site was
a randomization number (1 or 2) using a Microsoft Excel function analyzed using a paired t test. Multiple regression analysis was executed
(=ROUND[(2-1)*RAND()+1,0]) (Microsoft, Santa Rosa, CA) and to test the interaction between independent variables of topical anes-
applied 1 piece of Xylocaine gauze to the midpalatal mucosa. The thetic or placebo, higher or lower MDAS scores, and order of injection.
other piece of Xylocaine gauze was applied to the right side of the All statistical analyses were performed using SPSS 21.0 software
labial vestibule below the central incisor when the randomization (SPSS Inc, Chicago, IL). The level of significance was set at .05.
number was 1 and to the left side when the randomization number
was 2. The piece of water gauze was applied to the contralateral side
of the labial vestibule. All 3 pieces of gauze were removed after Results
2 min. Forty-four patients (16 men and 28 women; mean age,
A single operator (S.-Y. Cho) performed all injections. The upper 39.1 " 14.8 years; age range, 19–72 years) participated in this study.
lip and the labial mucosa were pulled with gloved fingers to make the There were no significant differences in the insertion and injection pain
injection sites taut. The needle (30-G; Morita, Osaka, Japan) was in- between the surgical site and the contralateral site (Table 1). Age and
serted 5 mm into the labial mucosa of the right central incisor, and, sex were not significant factors (P < .005).
immediately thereafter, the subject was asked to provide an NRS pain The insertion and injection pain was higher on the left site than on
score. An anesthetic solution (lidocaine hydrochloride and an epineph- the right site in all tests. The insertion pain in the placebo group was
rine injection [1:80,000]; Huons, Sungnam, Korea) was then injected significantly different between the 2 sites; however, the others showed
for 3 seconds with a speed of 0.432 mL/min using iCT injection SE (Gen- no significant differences (Table 2).
oss, Suwon, Korea), and the subject was asked again to rate his or her The topical anesthetic significantly reduced both insertion and in-
NRS pain score. The needle was withdrawn and inserted 5 mm into the jection pain (Table 3) compared with placebo. The mean pain scores
labial mucosa of the left central incisor, and, once again, the subject was during needle insertion were 2.34 " 1.679 in the placebo group and
asked to provide an NRS pain score. Finally, the anesthetic solution was 0.41 " 0.658 in the topical anesthetic group. The mean pain scores
injected for 3 seconds with a speed of 0.432 mL/min, and, immediately during the injection of anesthetic solution were 3.00 " 2.241 in the pla-
after, the subject was asked to report his or her NRS pain score. The 4 cebo group and 1.73 " 1.301 in the topical anesthetic group. These
scores were recorded on a case report form, and anesthesia for apical were all significantly different (P < .001).

TABLE 2. Comparison of Numeric Rating Scale Pain Scores between the Right and Left Site
Insertion Injection
Solution Site n Mean Standard deviation Significance Mean Standard deviation Significance
Placebo Right 23 1.65 1.301 .004* 2.43 1.701 .080
Left 21 3.10 1.786 3.62 2.617
Topical anesthetic Right 21 0.38 0.740 .790 1.52 1.206 .327
Left 23 0.43 0.590 1.91 1.434
*Statistically significant.

JOE — Volume -, Number -, - 2016 Pain from Needle Insertion and Injection 3
Consort Randomized Clinical Trial
TABLE 3. Comparison of Numeric Rating Scale Pain Scores between Placebo and Topical Anesthesia
Insertion Injection
Variable n Mean Standard deviation Significance Mean Standard deviation Significance
Placebo 44 2.34 1.697 <.001* 3.00 2.241 <.001*
Topical anesthetic 44 0.41 0.658 1.73 1.301
*Statistically significant.

The injection pain was significantly higher than the insertion pain As a result, in both the placebo and the topical anesthetic groups, there
in both the placebo and the topical anesthetic groups. The difference in were no differences in insertion or injection pain between the surgical
pain scores between the placebo group and the topical anesthetic group site and the contralateral site as shown in Table 1. This result suggests
was significantly greater for insertion pain (1.932 " 1.605) than for that apical periodontitis on the surgical site did not distort the data in
injection pain (1.273 " 1.675) (Fig. 2). this study.
Those with higher MDAS scores ($12) reported significantly The finding that the insertion and injection pain was higher on the
higher insertion pain scores in the placebo group and also significantly left site than on the right site in all tests was unexpected and surprising
higher injection pain scores in both the placebo and the topical anes- although only the insertion pain in the placebo group was significantly
thetic groups (Table 4). The only exception was insertion pain in the different between the 2 sites and the others showed no significant dif-
topical anesthetic group, which did not significantly differ by MDAS ferences (Table 2). The single operator who performed all the injec-
score. Multiple regression analysis revealed very low variance inflation tions was right-handed and positioned toward the right side during
factors of 1.015#1.040, which indicate no interactions between the in- the procedure; therefore, the reason for this result is assumed that it
dependent variables. would be easier on the right site than the left site to pull the labial mu-
cosa tautly, hold the injection device, and insert the needle slowly.
Many previous clinical studies that investigated the effects of
Discussion topical anesthesia conducted tests twice, once for the experimental
This randomized clinical trial was conducted to assess the prac- group and once for the control group. Resting phases lasting more
tical effectiveness of topical anesthesia under sensitively controlled con- than 2 weeks were designed as washout periods (2, 3). However,
ditions. Notably, this study only included patients who were already pain perception is affected by physical, psychological, and emotional
waiting for apical surgery on their upper anterior teeth. To reflect the states that change daily. An individual’s standards for evaluating
gingival flap for apical surgery, local anesthesia must be applied to a re- perceived pain are unlikely to remain perfectly consistent between
gion spanning 3 teeth in both directions from the target tooth. There- visits, which can lead to error. The discrepancy between the pain
fore, gingiva on the right and left central incisors must be included in reported immediately after a treatment and the subsequent memory
the anesthetic injection. This study capitalized on the injections planned of that pain increases in highly anxious patients (17, 18). To
for apical surgery at these 2 points below the right and left central in- eliminate these potential errors from this study, the experimental and
cisors to avoid performing any additional injections. This minimized control sites were each tested simultaneously, and the subjects were
the risks for each subject and ensured a favorable risk-benefit ratio asked to rate their NRS score immediately after each insertion or
for the study, which is a major ethical principle in clinical research injection for 3 seconds. The immediate rating of pain scores allowed
(15, 16). for the highest score to be recorded because the moment of insertion
One possible drawback of this study is that the surgical site and the and the initial seconds of the injection were found to be the most
contralateral site may have had different preexisting pain thresholds for painful periods during infiltration anesthesia.
injection because of the apical periodontitis on the surgical site. To Underlying conditions must be carefully controlled to identify even
reduce this risk of bias, this study included only subjects who showed small effects. The labial mucosa of the maxillary central incisors is
no interlateral differences in response to palpation before anesthesia. thought to be 1 of the most painful sites in the body (2, 3, 5) and is
therefore appropriate to represent a sensitive condition. Operational
procedures must be controlled for detailed trials. Injection speed has
4.5 a significant influence on perceived pain and should be controlled
4
(5, 19, 20). A computerized injection device was used in this study,
and the injection speed was kept constant and minimal at 0.432 mL/
3.5
min. Injections near the sinus tract were avoided to prevent a
3 discharge of anesthetic solution that could cause unintended pain
NRS pain score

2.5 reduction. The first injection of the anesthetic into the labial mucosa
Insertion of the right central incisor must be controlled to avoid generating an
2 Injection
anesthetic effect on the opposite labial mucosa, which is used to rate
1.5 insertion and injection pain. In this study, the injection time on the
1 right side was limited to just 3 seconds, and the needle was moved to
0.5
the left side immediately after being withdrawn from the right side.
The amount of anesthetic injected during the course of 3 seconds is
0
Placebo Topical anesthetic †Placebo-Topical
not sufficient to diffuse to the contralateral side and produce an
anesthetic effect.
Figure 2. A comparison of NRS pain scores between the time of needle inser- To analyze the pain scores of topical anesthetic and placebo
tion and the time of anesthetic solution injection. *Statistically significant. groups, some previous studies have used independent tests (eg, inde-
†
Placebo-topical; value to assess the extent of pain reduction. pendent t test or Mann-Whitney U test) (3, 4), whereas others have

4 Cho et al. JOE — Volume -, Number -, - 2016

 Consort Randomized Clinical Trial
TABLE 4. Comparison of Numeric Rating Scale Pain Scores between the Lower Modified Dental Anxiety Scale (MDAS) Group and the Higher MDAS Score Group
Insertion Injection
Solution MDAS n Mean Standard deviation Significance Mean Standard deviation Significance
Placebo <12 24 1.63 1.116 .003* 1.79 1.512 <.001*
$2 20 3.07 1.439 4.14 1.791
Topical anesthetic <12 24 0.47 0.612 .625 1.58 1.293 .037*
$2 20 0.36 0.745 1.94 0.975
*Statistically significant.

used paired tests (eg, paired t test or McNemar test) (2, 6, 7). An (Fig. 2), and this result is consistent with most recent studies (3, 7,
independent test includes an additional variation, resulting from the 23). Injection pain with a conventional dental syringe is typically
independence of the observations. A paired test is not subject to this greater than the pain caused by a computerized injection device.
variation because the paired observations are dependent. In addition, Therefore, it is apparent that injection pain constitutes most of the
a paired test does not require both samples to have equal variance. pain of infiltration anesthesia and is worth receiving greater attention
Therefore, a paired test provides more statistical power than an from dental practitioners. The effects of topical anesthesia on pain
independent test and is advantageous for a paired design, such as reduction at each step of the insertion and injection were compared
one involving a topical anesthetic group and a placebo group within by subtracting the pain scores of the topical anesthetic group from
the same subjects (21). those of the placebo group. The resulting data showed that the
In this study, the topical anesthetic was effective for both insertion anesthetic was more effective for insertion pain (pain
and injection pain. The mean insertion pain in the topical anesthetic reduction = 1.932 " 1.605) than for injection pain (pain
group (NRS = 2.34) was about one sixth of that of the placebo group reduction = 1.273 " 1.675), and this difference was significant
(NRS = 0.41), and the difference was statistically significant (Table 3). (Fig. 2). Topical anesthetics are thought to cross the oral mucosa via
Some previous studies have shown similar results (5–7, 22), whereas diffusion. The increase in concentration of the anesthetic solution inside
others have not (2, 3). The effectiveness of topical anesthesia remains the mucosa is continuous and relatively constant (29). Therefore, it is
controversial; however, the results of previous studies reveal a trend. understandable that topical anesthetics reduced pain more effectively
The effectiveness of topical anesthetics is reduced in studies with an during insertion than during injection.
application time of less than 1 minute (22–25) and with a 25-G needle The MDAS is 1 of the most popular tools used to assess dental anx-
insertion (9, 10, 23). Positive effects are shown in studies with an iety. It is simple, consists of just 5 questions (Fig. 1), and shows strong
anesthetic application time longer than 2 minutes and with a 27- or cross-cultural validity (30), and its completion alone does not increase
30-G needle insertion (26–28). In summary, an application time of anxiety (31). In this study, the subjects were divided into 2 groups: one
2 minutes or longer seems to be necessary for topical anesthetics to with a mean MDAS score lower than 12 and the other with a mean MDAS
exert a practical effect, and painful stimuli could attenuate the effect score of 12 or higher. The NRS pain score is a subjective value, and
of a topical anesthetic during infiltration anesthesia. In this study, a highly anxious people are known to provide a higher score than non-
topical anesthetic was applied for 2 minutes, and a 30-G needle was anxious people in response to the same pain. In this study, it is consis-
used. According to the application duration and needle gauge data tent that those with higher MDAS scores ($12) reported significantly
from previous studies, these conditions were sufficient for the anes- higher scores for both insertion and injection pain in the placebo group
thetic to be effective. Surprisingly, 30 (68%) of 44 total patients re- and for injection pain in the topical anesthetic group (Table 4). An
ported no pain (NRS = 0) upon insertion at the site of topical exception to this trend was that insertion pain in the topical anesthetic
anesthetic application. This is in accordance with Fukayama et al’s study group did not significantly vary by MDAS score (P = .625). Considering
(3) in which 13 (65%) of 20 total subjects reported pain scores of 0. the extent of the differences between subjects with higher and lower
These results suggest that dental practitioners are able to achieve pain- MDAS scores, subjects with higher MDAS scores revealed 2.3-fold
less insertions with a topical anesthetic. higher pain scores on injection (P = .003) and 1.9-fold higher pain
The mean injection pain of the topical anesthetic group scores on insertion (P < .001) than those with lower MDAS scores
(NRS = 1.73) was close to half of that of the placebo group in the placebo group. However, in the topical anesthetic group, subjects
(NRS = 3.00), and the difference was significant (Table 3). There with higher MDAS scores reported pain scores on injection that did not
are few previous studies on the positive effects of topical anesthesia significantly differ (P = .625) from those of subjects with lower MDAS
on injection pain, but those that exist mostly report application times scores and only 1.2-fold higher pain scores on insertion than those with
of 10 to 20 minutes (3, 7, 23), which are much longer than the 2 lower MDAS scores although this difference was significant (P = .037).
minutes used in this study. The most apparent difference between Highly anxious patients generally expect more pain than what actually
this study and the 3 studies mentioned previously is the injection occurs during dental treatment, whereas patients with low anxiety accu-
method. This study used a computerized injection device that rately predict the amount of pain they experience (17, 32). Thus, a
delivered a lidocaine solution at a speed of 0.432 mL/min. This possible explanation for this result is that highly anxious subjects
extremely slow and constant speed of injection cannot be reproduced expected more pain than what they were actually going to experience,
with a conventional dental syringe. In this study, the injection speed their threshold for pain subsequently increased, and therefore they
and injection pain were controlled well enough to avoid reported lower pain scores than they actually felt.
overpowering the effects of the topical anesthetic. This is likely the In conclusion, topical anesthesia showed significant effects on
reason for the topical anesthetic’s positive effect on injection pain, reducing both the pain of insertion and injection during infiltration
despite the brief application time. anesthesia in the maxillary central incisors. Injection pain was signifi-
Injection pain was significantly higher than insertion pain, even cantly greater than insertion pain regardless of the topical anesthetic
though a computerized injection device was used in this study application, and the extent of pain reduction was greater for insertion

JOE — Volume -, Number -, - 2016 Pain from Needle Insertion and Injection 5
Consort Randomized Clinical Trial
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