Journal of Pharmacy And Bioallied Sciences

: 2021  |  Volume : 13  |  Issue : 5  |  Page : 646--650

To compare and analyze the potency of two topical anesthetic gels in reducing inferior alveolar injection pain in children of 8–12 years: A double-blinded clinical trial

Dharati Patel1, Banibrata Lahiri2, Mohamed Abd-Ellatif El-Patal3, Abdulfatah Alazmah4, Parth Patel5, Yousef H Abokhlifa6,  
1 Department of Pedodontics and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar, Gujarat, India
2 Department of Oral and Maxillofacial Surgery, Kalinga Institute of Dental Sciences, KIIT (Deemed to be University), Bhubaneswar, Odisha, India
3 Department of Pedodontics and Oral Health, College of Dentistry, Al Azhar University, Cairo, Egypt; Department of Preventive Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Alkharj, Kingdom of Saudi Arabia
4 Department of Preventive Dental Sciences, College of Dentistry, Prince Sattam Bin Abdul Aziz University, Alkharj, Kingdom of Saudi Arabia
5 Dental Practitioner, Gujarat University, Ahmedabad, Gujarat, India
6 Department of Pedodontics and Oral Health, College of Dentistry, Al Azhar University, Cairo, Egypt

Correspondence Address:
Dharati Patel
Department of Pedodontics and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar, Gujarat


Aim: To compare and analyze the clinical adequacy of two topical anesthetic gels, Precaine (8% lidocaine + 0.8% dibucaine) and Precaine B (20% benzocaine) in children before intraoral local anesthetic injections. Materials and Methods: This clinical study included thirty children who needed an inferior alveolar nerve block. They were divided into three groups: Group A: Precaine topical gel group, Group B: Precaine B topical gel Group, Group C: no anesthetic topical gel group (control group). These two effective topical gels were applied before giving intraoral local anesthesia, and afterward, the child's pain response was surveyed utilizing the Wong-Baker Faces Pain Rating Scale. The scores obtained were subjected to statistical analysis. Results: Intergroup comparison showed a significant mean difference between the control group and Precaine group (P > 0.05) as well as Precaine B group (P > 0.05). However, there is no significant difference obtained between Group A and Group B (P < 0.05). Conclusion: It is psychologically and clinically beneficial to apply a topical anesthetic agent before injecting any intraoral anesthesia. In this study, both anesthetic gels showed a nonsignificant difference in reducing inferior alveolar injection pain, but Precaine B shows more promising results than Precaine.

How to cite this article:
Patel D, Lahiri B, El-Patal MA, Alazmah A, Patel P, Abokhlifa YH. To compare and analyze the potency of two topical anesthetic gels in reducing inferior alveolar injection pain in children of 8–12 years: A double-blinded clinical trial.J Pharm Bioall Sci 2021;13:646-650

How to cite this URL:
Patel D, Lahiri B, El-Patal MA, Alazmah A, Patel P, Abokhlifa YH. To compare and analyze the potency of two topical anesthetic gels in reducing inferior alveolar injection pain in children of 8–12 years: A double-blinded clinical trial. J Pharm Bioall Sci [serial online] 2021 [cited 2023 Feb 2 ];13:646-650
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One of the most effective tools for child behavior management in pedodontics is local anesthesia, as it controls pain and hence marked a reduction in anxiety accompanying it. Contradictory, administration of local anesthetic itself produces pain, anxiety, and tension that may cause resulting negative behavior.[1] Local anesthesia can affect individuals of all ages; however, the condition seems to grow generally in childhood.[2],[3],[4],[5] Pain is extremely complex and multidimensional, the control of which is significant to instill a positive dental attitude in children.[6] Various methods of reducing injection pain in children can be broadly categorized as psychological and physical.

In pediatric dentistry, it is important to acknowledge that the pain sensation is not necessarily reliant on tissue damage; it might likewise be created by condition stimuli, for example, the sound of the drill or the touch of the needle during local anesthetic injections. Anxiety is one of the major issues hindering the quality of dental treatment in children, and the injection is the most anxiety-provoking procedure.[7],[8],[9] Henceforth, there is a need to discover more comfortable and pleasant delivery systems for local anesthesia in children.

Major two aspects of local anesthetic injection that can cause pain are needle insertion and the deposition of the solution into the tissue. Topical anesthesia has been broadly advocated as a method for reducing the discomfort and tension associated with needle insertion and is an essential component of the atraumatic administration of intraoral local anesthesia.[10],[11] The extra time needed to apply topical anesthesia may build the child's apprehension concerning the approaching procedure.

Topical anesthesia is a pivotal part of local anesthesia administration since it has both psychological and pharmacological impact. By blocking the transmission of signals from the terminal fibers of the sensory nerves, topical anesthetics control pain perception and hence modify the reaction to pain. Their effects are restricted to the control of painful stimuli occurring on or just underneath the mucosa. Topical anesthetics are available as gels, sprays, ointments, or even as an adhesive patch.[12],[13],[14] The factors that impact the adequacy of topical anesthetics include the agent and its duration of application, concentration, and site of application.[15],[16]

Thus, the fundamental aim of conducting the present clinical study was to compare and analyze the potency of Precaine® B (20% benzocaine) with Precaine® (8% lidocaine + 0.8% dibucaine) in reducing pain during inferior alveolar nerve block (IANB).

 Materials and Methods

The current double-blind clinical research was conducted on thirty patients (females – 14, males – 16) of the age group of 8–12 years, attending the Outpatient Department of Pediatric Dentistry at Ahmedabad Dental College and Hospital between July 2016 and September 2016. They were chosen based on the nonprobability proportional quota sampling technique. Ethical clearance was obtained from the Institutional Ethical Review Board. All parents were informed about the study protocol, and prior written consent was obtained. Inclusion criteria were children with good general health (American Society of Anesthesiologists I–II) without any history of allergic reactions as determined by a written history and personal interview of the parent and children not taking any medication that would alter their pain perception. Children demonstrating definitely negative behavior (Frankel behavior rating scale) during their initial examination visit were excluded from the study.

The recruited children were randomly divided into three groups: Group A: Precaine gel (Strawberry flavored) (8% lidocaine + 0.8% dibucaine); Group B: Precaine-B gel (Strawberry flavored) (20% benzocaine); Group C: Control group used colored strawberry gel without any anesthetic effect [Figure 1] and [Figure 2]. The procedural details were explained to all the children per the extent of their cognitive understanding and every child was apprised of the Wong-Baker faces pain rating scale.{Figure 1}{Figure 2}

Children indicated for dental extractions, pulpal treatments, or operative procedures in the mandibular arch, who needed only IANB on any side, were tested. A single operator throughout the study performed all the procedures. The child, as well as the operator, was blinded to the type of products getting utilized. The anesthetic agent of 0.5 ml was applied on a dried oral mucous membrane with moderate pressure with rubbing circular motion for 30–45 s using a cotton applicator tip or small cotton pallet [Figure 3]. One or 2 min after the application of topical agent in an exceedingly confined area, an excess agent was cleaned with gauze piece to avoid gag reflexes, and administration of local anesthetic Xicaine® was carried out using single-use syringe Unolock®. The local anesthetic agent was administrated at a rate of 1 ml/min with a needle size 0.55 × 25 mm.{Figure 3}

Immediately, after the needle prick, once the patient became stable, the assessments of pain response were carried out. An assessment form was given to the child, which include personal details and Wong–Baker pain scale image [Figure 4]. The child was instructed to fill his/her personal data and mark his/her response to pain over the Wong-Baker faces pain rating scale as explained preoperatively [Figure 5]. Thus, obtained data were subjected to statistical analysis without revealing the identity of the test topical anesthetic products.{Figure 4}{Figure 5}


Initially, the scores from the Wong-Baker faces pain rating scale of thirty children were obtained, and then it was stored in an excel spreadsheet (Microsoft, Inc., Redmond, Wash). For the present study, the statistical analysis was carried out using the Statistical Package for the Social Sciences (SPSS, Inc.,Chicago, I11). Mean score was obtained by one-way ANOVA test, and intergroup comparison was obtained by post hoc test [Table 1] and [Table 2].{Table 1}{Table 2}

Higher mean scores have been obtained for the control group (7.00 ± 2.36) for IANBs under the Wong-Baker faces pain rating scale. The mean score acquired from Precaine B (Group-B) under the Wong-Baker faces pain rating scale was the lowest (2.80 ± 2.15) among all three groups. Precaine (Group-A) shows a mean score of 4.20 ± 0.63 [Graph 1].[INLINE:1]

Intergroup comparison showed the significant mean difference between the control group and Precaine group (P > 0.05) as well as Precaine B group (P > 0.05). However, there is no significant difference obtained between Group A and Group B (P < 0.05).


The thought and performance of local anesthetic injection often provoke feelings of discomfort for the patient, especially in children and have been described as one of the most anxiety-provoking procedures in dentistry. Providing enjoyable, comfortable, and happy memories for children throughout their dental visits is one of the foremost necessary aims of pediatric dentistry. Fear-related hysterical behaviors associated with dental injections are undoubtedly among the foremost difficult aspects of pediatric dentistry. Proper administration of intraoral local anesthesia is the mainstay of pain management throughout the dental procedures.[3],[17] Therefore, any procedure that effectively reduces the unpleasantness of dental injection could serve as a positive reinforcement toward obtaining dental care. Topical anesthesia is the most commonly advocated technique to reduce pain associated with oral injections.

Nowadays, the major local anesthetics in routine clinical use can be divided into two broad groups – agents containing an ester linkage such as benzocaine and agents containing an amide linkage such as lidocaine and dibucaine.[18] Although there are many different newer formulations of a topical anesthetic for intraoral uses are available, lidocaine and benzocaine remained the most commonly used topical anesthetics by dental practitioners. Adriani et al. investigated several different topical anesthetics by electrical stimulation of the mucous membrane and reported that drugs such as dibucaine were the longest acting.[19] Lidocaine has a faster onset and besides having excellent anesthetic efficacy. On the contrary, benzocaine is absorbed slowly due to its low aqueous solubility, and it has also reported a few localized allergic reactions.[11] Hence, this study has been planned to compare and analyze the effectiveness of a combination of 8% lidocaine and 0.8% dibucaine against 20% benzocaine for inferior alveolar injection in children.

Each topical anesthetic formulation exhibits two beneficial effects. The first one is the pharmacological effect because of anesthetic agents. Apart from it, the topical anesthetic gel also has psychological benefits, which are mainly attributed to the placebo effect. Preprocedural explanation to each child about the benefits of topical anesthetic agents was carried out in the present study. Pollack in his study perceived that patients who were given a verbal reinforcement about the effects of topical anesthesia reacted less severely to local anesthetic injection compared with those given no such information.[20]

In our study, the topical anesthetic gels were applied with moderate pressure with rubbing circular motion for 30–45 s to a confined area and left for about 1–2 min to increase the depth of penetration which is based on the principle that the duration of application of the anesthetic influences the amount of penetration. To minimize the sensation of pain from the injection, it was generally recommended to use a topical anesthetic agent for at least 1 min.[8]

Giddon et al. evaluated the topical anesthetics in different and dosage forms and reported that there was no difference among 20% benzocaine, 5% lidocaine, and placebo when applied for 30 s on palate using 25G needle.[21] Similarly, our Precaine® has not shown any significant difference with Precaine® B. Nakanishi et al. in his research mentioned no difference between 20% benzocaine and placebo even after application for 4 min in the pterygotemporal region when the injection was carried out.[22]

In this clinical study, the Wong-Baker faces pain rating scale was utilized because it is simple to grasp and applicable to people designated. The subjective scale used was the Wong-Baker faces pain rating scale, which measures the degree of unpleasantness or effective dimension of a child's pain experience, especially in children aged from 3 to 17 years. According to Cohen et al., the WFPS scale has been translated into over thirty languages and showed good construct validity as a self-report pain measure.[11]


This study concludes that topical anesthetics do have a pharmacological and psychological effect when used on the oral mucosa. They can be anticipated to reduce the discomfort of needle penetration in the mucosa. Sensible use of topical anesthesia on oral mucosa leads to fewer and less severe adverse effects. However, in the present study, both anesthetic gels fulfilled the fundamental aim and showed a nonsignificant difference in reducing injection pain, but Precaine B shows more promising results. It is always beneficial to apply flavored anesthetic gels in children as it developed more acceptance. However, further studies are required to evaluate the effectiveness of Precaine B for other injection sites.

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Conflicts of interest

There are no conflicts of interest.


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