Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Study Overview
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Brief Summary
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Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

Detailed Description
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A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).

Official Title
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Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial

Conditions
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Anesthesia, Dental

Intervention / Treatment
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* Drug: Topicale GelPatch (Benzocaine 18%)
* Drug: Benzocaine oral gel 20%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ranging in age from 6 to 8 years. Healthy children with no contraindications of use of local anesthetics. Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I) Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections. Exclusion Criteria: Uncooperative children or with intellectual or physical disabilities or medical conditions. Children with acute pain or emergency visits. Children with previous negative dental experience. Children receiving premedications or analgesics 48 hours before testing. children/parents not willing to participate.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth randomized clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Topicale® topical anesthetic gel patch (Benzocaine 18%) | Drug: Topicale GelPatch (Benzocaine 18%)<br>* Intervention group<br>|
| Placebo Comparator: control group<br>Opahl® topical anesthetic gel (Benzocaine 20%) | Drug: Benzocaine oral gel 20%<br>* control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection | The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale Sound, Eye, Motor scale: Grade 1: Comfort Sound: No sound Eye: No signs Motor: Relaxed body and hand Grade 2: Mild discomfort Sound: Non specific sound Eye: Dilated without tears Motor: Muscular contractions of hand Grade 3: Moderate discomfort Sound: Verbal compliant, louder sound Eye: Tears, sudden eye movement Motor: Sudden body and hand movements Grade 4: Severe discomfort Sound: Verbal compliant shouting, crying Eye: Crying, tears all over face Motor: Hand movement for defense, Turning the head to opposite side | 4 months | 
| Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection | Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R). 2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so 0 = no pain and 10 = very much pain. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benzocaine, Topical, oral patch, pain, dental anesthesia, children