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ORIGINAL ARTICLE
Year : 2020  |  Volume : 38  |  Issue : 2  |  Page : 184-189
 

A comparative evaluation of pain perception following topical application of benzocaine gel, clove-papaya based anesthetic gel and precooling of the injection site before intraoral injections in children


Department of Pedodontics and Preventive Dentistry, DAPM R V Dental College, Bengaluru, Karnataka, India

Date of Submission28-May-2018
Date of Decision15-Aug-2019
Date of Acceptance20-Jun-2020
Date of Web Publication28-Jun-2020

Correspondence Address:
Dr. Jiline Mary Sabu
33/4767 A, Golf Link Road, Malaparamba, Calicut - 673 009, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISPPD.JISPPD_153_18

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   Abstract 


Background and Aim of the Study: The topical anesthetic property of clove remains unexplored even though it has been widely used in dentistry since ages. Hence, the aim of the study was to compare the topical anesthetic efficiency of precooling with ice, clove–papaya based topical gel and benzocaine gel in pediatric patients. Methodology: Sixty healthy children aged 9–10 years who required local anesthetic injections for dental procedures were selected and divided into three groups with 20 patients each. In the first visit, written consent and intraoral screening of the patients were performed. In the second visit, the topical anesthetic agents were applied in the respective groups for 1 min and later local anesthetic injections were administered. Pain perception was evaluated using Sound, Eye, Motor Scale (SEM scale) and Wong Baker Faces Pain Rating Scale (WBFPRS), tabulated, and statistically analyzed. AResults: The test results demonstrated that benzocaine group has the highest mean WBFPRS score followed by clove–papaya group and then ice cone group. The ice group showed the least mean SEM scale score, followed by the benzocaine group and then clove–papaya group. However, the mean WBFPRS score and the mean SEM scale score did not show any statistically significant difference. Interpretation and Conclusion: All the three topical anesthetic agents provided similar surface anesthesia in children. The newly introduced clove–papaya based topical anesthetic gel showed encouraging results, hence can be used as a potent topical anesthetic agent.


Keywords: Benzocaine, clove–papaya based anesthetics gel, ice, precooling, Sound, Eye, Motor scale, topical anesthesia, Wong Baker Faces Pain Rating Scale


How to cite this article:
Anantharaj A, Sabu JM, Ramakrishna S, Jagdeesh RB, Praveen P, Shankarappa PR. A comparative evaluation of pain perception following topical application of benzocaine gel, clove-papaya based anesthetic gel and precooling of the injection site before intraoral injections in children. J Indian Soc Pedod Prev Dent 2020;38:184-9

How to cite this URL:
Anantharaj A, Sabu JM, Ramakrishna S, Jagdeesh RB, Praveen P, Shankarappa PR. A comparative evaluation of pain perception following topical application of benzocaine gel, clove-papaya based anesthetic gel and precooling of the injection site before intraoral injections in children. J Indian Soc Pedod Prev Dent [serial online] 2020 [cited 2020 Jul 7];38:184-9. Available from: http://www.jisppd.com/text.asp?2020/38/2/184/288216





   Introduction Top


Since achieving an appropriate anesthesia is crucial in clinical dentistry, various desensitization techniques have been tried in the past to deliver adequate local anesthesia in children.[1],[2],[3],[4],[5],[6]

Search for novel bioactive compounds from medicinal plants[7],[8] has gained immense importance, but a scarcity in literature regarding the topical anesthetic property of clove has been noted even though it has been successfully used in dentistry for ages. Hence, the current study aimed at comparing the topical anesthetic ability of the newly developed clove–papaya based gel with topical benzocaine and precooling of the site with ice in children.


   Methodology Top


Sixty healthy children aged 9–10 years who required local anesthetic injections for dental procedures were selected. They were selected from the patients visiting the Department of Pedodontics and Preventive Dentistry, DAPMRV Dental College, Bengaluru.

Inclusion criteria

  1. Patients requiring local anesthesia for dental procedures
  2. Patients who are willing to participate in the study.


Exclusion criteria

  1. Patients with a history of systemic disease, psychiatric disorders, sensitive skin, and dental abscesses in the procedure site
  2. Patients who have allergic history to local anesthesia
  3. Patients who are unable to follow the instructions or uncooperative.


The study protocol was approved by the institutional review committee of the college. The purpose of the study was explained to the children and their parents, and a voluntarily written informed parental consent was obtained. In the first visit, an intraoral screening was performed and patients requiring local anesthetic injections for further dental procedures were selected [Figure 1]. Children were randomly divided into three study groups with 20 subjects in each group using chit system.
Figure 1: Diagnostic and isolation tools

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The three study groups are as follows:

  • Group 1: Ice cone group
  • Group 2: Benzocaine group
  • Group 3: Clove–papaya extract group.


Once the children were allocated into the respective groups, the sites for the application of the topical anesthetic agents were determined, marked, and isolated. The topical anesthetic agents were applied in the respective groups for 1 min [Figure 2]. The site of application was determined according to the treatment needs of the patient. The topical anesthetic agents were applied onto the mucosa for 1 min using sterile, cotton applicator [Figure 3]. The ice cones used for the study were made by filling water in the small finger of latex gloves, knotting it and freezing it.
Figure 2: Materials used for topical anesthesia and local anesthetic

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Figure 3: Application of the agents using cotton applicator

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Following the application of the topical anesthetics and precooling of the site in the respective groups, local anesthetic injections were performed using 0.45 mm × 38 mm sterile single use syringes. Standard protocols for injections in children were considered during the procedure. After local anesthetic (LA) injections, the patients were asked to individually rate their pain experience using visual analog scale. The pain perception was evaluated using the Wong Baker Faces Pain Rating Scale (WBFPRS) by the patient immediately after the LA procedure [Figure 4]. The Sound, Eye, Motor Scale (SEM scale) evaluation was carried out by a trained personnel present in the dental operatory. The procedures were video recorded for future references. The scores were calculated and tabulated. The mean WBFPRS and SEM scores were evaluated with analysis of variance (ANOVA) test followed by Bonferroni post hoc analysis.
Figure 4: Self-evaluation by the child using Wong Baker Faces Pain Rating Scale

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The statistical analysis was done using the Statistical Package for the Social Sciences for Windows, version 22.0., released 2013., IBM Corp., Armonk, NY, USA. It includes expression of the WBFPRS scores and SEM scores in mean, standard deviation, and range, whereas age and gender distribution in number and percentage. One-way ANOVA test was used to compare the mean WBFPRS scores and SEM scale scores between the three study groups. The comparison of the three different study groups based on gender and age was done using Chi-square test. The confidence level of the study was proposed to be 95% and hence the level of significance (P value) was set at P < 0.05.


   Results Top


The results are presented in terms of age [Graph 1] and gender distribution of patients [Graph 2], [Table 1]). The test results demonstrate that Benzocaine group have the highest mean WBFPRS score followed by Clove-papaya group and then Ice cone group ([Graph 3], [Table 2]). When comparing the SEM scores, Ice group showed least mean SEM scale score followed by the Benzocaine group and then Clove-papaya group ([Graph 4], [Table 3]). However the mean WBFPRS score and mean SEM scale score did not show any statistically significant difference.

Table 1: Comparison of study groups based on their age and gender distribution

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Table 2: Comparison of mean Wong Baker Faces Pain Rating Scale scores for pain between different study groups

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Table 3: Comparison of mean Sound, Eye, Motor Scale scores between different study groups

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Table 4: Wong Baker Faces Pain Rating Scale

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Table 5: Sound, Eye, Motor Scale for the assessment of child's behavior

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   Discussion Top


Among the various methods used to alleviate pain caused by needle penetration, topical anesthetics stand apart as the gold standard method. Various studies have been conducted on the different topical anesthetic agents for comparing their efficacy, potency, duration of action, and adverse effects.[5],[6],[9]

The newly developed clove–papaya based topical anesthetic gel (eco pain care) contains clove oil (3%), chloramine (1%), and papaya extract (10%) with eugenol as the bioactive molecule. Chloramine is used as a gelling agent along with 10% papaya which acts as a vehicle (medium) during the preparation of the agent. Various animal studies have been conducted using the agent and it was proven safe for use.

Clove represents one of the major vegetal sources of phenolic compounds. Clove oil is an essential oil extracted from Syzygium aromaticum. Clove and clove oils are used safely in food, beverages, and even toothpastes. The mechanism involved in the analgesic activity of clove oil has been attributed to the activation of calcium and chloride channels in ganglion cells. The voltage-dependent effects in sodium and calcium channels and in the trigeminal ganglion receptors also contributed to its analgesic effect. The peripheral analgesic activity of eugenol was reported at the doses of 50, 75, and 100 mg/kg.[10],[11]

Eugenol has been widely tested to determine its safety for human use and consumption. Cloves, clove oil, and eugenol are all generally recognized as safe in humans when used at levels not exceeding 1500 ppm and listed by the US Food and Drug Administration in 1978. Clove oil has been used as an effective, local, and natural anesthetic agent in hatcheries and marine research studies to immobilize fish for handling, sorting, artificial reproduction techniques, etc.[12],[13]

Studies conducted by Grollman in 1962, Curtis in 1990, and Keene in 1998 suggest that clove oil can be used as a potent topical anesthetic agent on various animal and fish species.[14],[15]

The current study included 60 children aged 9–10 years due to their improved cognitive ability and lesser variation in the pain perception. Different individuals were selected for the application of different agents in order to prevent any bias in pain perception due to anticipated pain which can occur at the second appointment. The application time of the reagents were restricted to 1 min in order to enhance better tolerance and cooperation among the pediatric patients. The study design opted only buccal infiltration anesthesia because of the reduced tissue trauma and depth of penetration of the needle during the administration of the local anesthetic agent when compared to nerve blocks in the current study; lignocaine 2% was used with adrenaline in the ratio of 1:80,000 for providing local anesthesia. In the present study, the WBFPRS was used as the visual analog scale for self-reporting, and Sensory, Eye, and Motor Scale was used by the observer to assess the pain perception during local anesthetic injections. The study phase of the treatment was videotaped using a standard video camera in the dental operatory for further references. The study design was formulated based on similar studies conducted by Aminah et al. in 2017,[4] Ghaderi et al. in 2013,[5] Alquareer et al. in 2006,[16] Mohinuddin et al. in 2015,[17] Kreider et al. in 2001.[18]

The current test results demonstrated that even though all the three topical agents should lower pain perception, there was no statistically significant difference between them.

In the current study, both topical benzocaine and clove–papaya based anesthetic had reduced pain perception, but was not statistically significant. This is in concurrence with the previous study conducted by Alqareer et al. in 2006 on topical benzocaine and homemade clove gel.[16] Similarly, when ice and benzocaine were compared, the difference is not statistically significant even though ice has shown better results. This finding is in contrast to the previous literature by Ghaderi et al. and Mohinuddin et al. which showed significant difference among the agents.[5],[17] In the current study, there was no significant difference in pain perception noted between males and females. This finding is in accordance with a study by Allen et al. in 2002, which reported that there is no significant gender-specific difference in children's reaction to intraoral injections.[5],[17] Another important finding of the current study was that the use of euphemisms such as ice candy for ice cubes and strawberry gel for the topical anesthetic gels made the patients less anxious. In the current study, no adverse effects were noted immediately or at a later period of time. This is contrary to studies conducted by Alqareer et al. in 2014[16] and Sarrami et al. in 2002,[19] which reported few adverse reactions associated with the use of eugenol.

A control group was not considered even though it was a significant limitation of the current study due to ethical issues. In general, the rate of injection and needle depth were kept consistent, but not identical because of the variable anatomy encountered. Attempts were made not to exert additional pressure when placing the agents.


   Conclusion Top


Within the limitations of the present study, we conclude that,

  • All the three topical anesthetic agents provided similar surface anesthesia on the pain perception in children, thereby reducing their fear and anxiety
  • In the present study, among the three agents, precooling of the injection site before LA provided better anesthetic results when compared to other agents, even though statistically significant difference was not obtained.


The results of the newly developed clove–papaya based topical anesthetic gel were comparable to benzocaine gel and hence possess a potential to be an effective herbal topical agent.

Recommendations

  • Further studies with larger sample size, varied concentrations of clove oil, varied duration time of application, and presence of control group should be conducted for the better evaluation of the agent.


Acknowledgment

We would like to thank the Vittal Mallya Scientific Research Foundation, Bengaluru, especially Dr. Anil Kush for the help provided during the study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Brand K, Thorpe B. Pain assessment in children. Anaesth Intensive Care Med 2016;17:270-3.  Back to cited text no. 1
    
2.
Aminabadi NA, Farahani RM. The effect of pre-cooling the injection site on pediatric pain perception during the administration of local anesthesia. J Contemp Dent Pract 2009;10:43-50.  Back to cited text no. 2
    
3.
Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of different precooling agents and topical anaesthetics on the pain perception during intraoral injections: A comparative clinical study. Int J Clin Pediatr Dent 2015;8:119-22.  Back to cited text no. 3
    
4.
Aminah M, Nagar P, Singh P, Bharti M. Comparison of topical anesthetic gel, pre-cooling, vibration and buffered local anesthesia on the pain perception of pediatric patients during the administration of local anesthesia in routine dental procedures. Int J Contemp Med Res 2017;4:400-3.  Back to cited text no. 4
    
5.
Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: “A randomized clinical trial”. Dent Res J (Isfahan) 2013;10:790-4.  Back to cited text no. 5
    
6.
Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, et al. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res 2016;10:13-6.  Back to cited text no. 6
[PUBMED]  [Full text]  
7.
WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems. Geneva, Switzerland: World Health Organization: 2004.  Back to cited text no. 7
    
8.
Praveen N, Nayak S, Kar DM, Das P. Pharmacological evaluation of ethanolic extracts of the plant Alternantherasessilis against temperature regulation. J Pharm Res 2010;3:1381-3.  Back to cited text no. 8
    
9.
Franz-Montan M, Ribeiro LN, Volpato MC, Cereda CM, Groppo FC, Tofoli GR, et al. Recent advances and perspectives in topical oral anesthesia. Expert Opin Drug Deliv 2017;14:673-84.  Back to cited text no. 9
    
10.
Cortés-Rojas DF, de Souza CR, Oliveira WP. Clove (Syzygium aromaticum): A precious spice. Asian Pac J Trop Biomed 2014;4:90-6.  Back to cited text no. 10
    
11.
Milind P, Deepa K. Clove: A champion spice. Int J Res Ayurveda Pharm 2011;2:47-54.  Back to cited text no. 11
    
12.
Chaieb K, Zmantar T, Ksouri R, Hajlaoui H, Mahdouani K, Abdelly C, et al. Antioxidant properties of the essential oil of Eugenia caryophyllata and its antifungal activity against a large number of clinical Candida species. Mycoses 2007;50:403-6.  Back to cited text no. 12
    
13.
Javahery S, Nekoubin H, Moradlu AH. Effect of anaesthesia with clove oil in fish (review). Fish Physiol Biochem 2012;38:1545-52.  Back to cited text no. 13
    
14.
Woody CA, Nelson J, Ramstad K. Clove oil as an anaesthetic for adult sockeye salmon: Field trials. J Fish Biol 2002;60:340-7.  Back to cited text no. 14
    
15.
Keene JL, Noakes DL, Moccia RD, Soto CG. The efficacy of clove oil as an anaesthetic for rainbow trout, Oncorhynchus mykiss (Walbaum). Aquac Res 1998;29:89-101.  Back to cited text no. 15
    
16.
Alqareer A, Alyahya A, Andersson L. The effect of clove and benzocaine versus placebo as topical anesthetics. J Dent 2006;34:747-50.  Back to cited text no. 16
    
17.
Mohiuddin I, Shetty JV, Srinivasan I, Ahmed J. Topical application of local anaesthetic gel vs. ice in pediatric patients for infiltration anaesthesia. J Evol Med Dent Sci 2015;4:12934-40.  Back to cited text no. 17
    
18.
Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: Lidocaine patches versus topical benzocaine gel. Pediatr Dent 2001;23:19-23.  Back to cited text no. 18
    
19.
Sarrami N, Pemberton MN, Thornhill MH, Theaker ED. Adverse reactions associated with the use of eugenol in dentistry. Br Dent J 2002;193:257-9.  Back to cited text no. 19
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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