Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Overview

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.

Full Title of Study: “Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 13, 2020

Detailed Description

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).

Interventions

  • Drug: Topicale GelPatch (Benzocaine 18%)
    • Intervention group
  • Drug: Benzocaine oral gel 20%
    • control group

Arms, Groups and Cohorts

  • Active Comparator: Intervention group
    • Topicale® topical anesthetic gel patch (Benzocaine 18%)
  • Placebo Comparator: control group
    • Opahl® topical anesthetic gel (Benzocaine 20%)

Clinical Trial Outcome Measures

Primary Measures

  • Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection
    • Time Frame: 4 months
    • 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
  • Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
    • Time Frame: 4 months
    • 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”.

Participating in This Clinical Trial

Inclusion Criteria

1. Children ranging in age from 6 to 8 years. 2. Healthy children with no contraindications of use of local anesthetics. 3. Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I) 4. Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections. Exclusion Criteria:

1. Uncooperative children or with intellectual or physical disabilities or medical conditions. 2. Children with acute pain or emergency visits. 3. Children with previous negative dental experience. 4. Children receiving premedications or analgesics 48 hours before testing. 5. children/parents not willing to participate.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dina Youssef Attia
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dina Youssef Attia, Assistant lecturer – Alexandria University
  • Overall Official(s)
    • Huda M Ibrahim, BSc, Principal Investigator, Alexandria University
    • Amina Abdelrahman, PhD, Study Director, Alexandria University
    • Aly Sharaf, PhD, Study Director, Alexandria University

Citations Reporting on Results

Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12.

Stecker SS, Swift JQ, Hodges JS, Erickson PR. Should a mucoadhesive patch (DentiPatch) be used for gingival anesthesia in children? Anesth Prog. 2002 Winter;49(1):3-8.

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