Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Dina Youssef Attia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Anesthesia, Dental

Treatments: Drug: Benzocaine oral gel 20%; Drug: Topicale GelPatch (Benzocaine 18%)

Study type: Interventional

Funder types: Other

Identifiers

NCT04317508

Benzocaine gel patch

Details and patient eligibility

About

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 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).

Enrollment: 50 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Topicale® topical anesthetic gel patch (Benzocaine 18%)

Treatment:

Drug: Topicale GelPatch (Benzocaine 18%)

control group

Placebo Comparator group

Description:

Opahl® topical anesthetic gel (Benzocaine 20%)

Treatment:

Drug: Benzocaine oral gel 20%