Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Dina Youssef Attia50 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia, Dental

Interventions

Topicale GelPatch (Benzocaine 18%)DRUG

Intervention group

Benzocaine oral gel 20%DRUG

control group

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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".

Time frame: 4 months

Data from ClinicalTrials.gov

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