Clinical trial NCT04317508: Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection
Official title: Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anesthesia, Dental
Keywords: benzocaine
Topical
oral patch
pain
dental anesthesia
children
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth randomized clinical trial.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection
timeFrame: 4 months
measure: Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Huda M Ibrahim, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Amina Abdelrahman, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Aly Sharaf, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.