Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Dental
• Intervention / Treatment: Drug: Topicale GelPatch (Benzocaine 18%); Drug: Benzocaine oral gel 20%

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dina Youssef Attia
• Investigators: Principal Investigator: Huda M Ibrahim, BSc, Alexandria University; Study Director: Amina Abdelrahman, PhD, Alexandria University; Study Director: Aly Sharaf, PhD, Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pain; children; Topical; benzocaine; oral patch; dental anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: Benzocaine gel patch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No