Anesthesia, Dental
Conditions
Keywords
benzocaine, Topical, oral patch, pain, dental anesthesia, children
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).
Interventions
DRUGTopicale GelPatch (Benzocaine 18%)
Intervention group
DRUGBenzocaine oral gel 20%
control group
Sponsors
Dina Youssef Attia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
* Administration of local anesthetic will be video recorded. * An independent investigator who is blinded to the type of topical applied will evaluate the outcome from the video recordings.
Intervention model description
Split mouth randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Egypt
Outcome results
None listed