Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Anesthesia, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317508
• Other study ID #: Benzocaine gel patch
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: March 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 19, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Dental

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Dina Youssef Attia

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Bågesund 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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