Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Phase 1

Completed

• Conditions: Anesthesia, Dental
• Interventions: Drug: Benzocaine oral gel 20%; Drug: Topicale GelPatch (Benzocaine 18%)

• Registration Number: NCT04317508
• Lead Sponsor: Dina Youssef Attia

Brief Summary

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

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 Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-19
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Benzocaine oral gel 20%	Opahl® topical anesthetic gel (Benzocaine 20%)
Intervention group	Topicale GelPatch (Benzocaine 18%)	Topicale® topical anesthetic gel patch (Benzocaine 18%)

Primary Outcome Measures

Name	Time	Method
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection	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".
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection	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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt