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Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children

Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05857033
Enrollment
48
Registered
2023-05-12
Start date
2023-01-05
Completion date
2023-05-20
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Keywords

Dental injection, Palatal injection, Indirect palatal injection

Brief summary

Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.

Interventions

OTHERBuccal and direct palatal injection with the aid of Buzzy

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection

OTHERBuccal and indirect palatal injection with the aid of Buzzy

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection

OTHERBuccal and direct palatal injection without Buzzy

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection

OTHERBuccal and indirect palatal injection without Buzzy

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are in need of extraction of maxillary posterior teeth. * Children free of any systemic disease or special health care needs (ASA I). * Children with no learning disabilities. * Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale. * Patients whose parents will give consent to participate.

Exclusion criteria

* Having active sites of pathosis in the area of injection that could affect the anesthetic assessment. * Signs of reversible pulpitis. * Restorable tooth. * Patients allergic to local anesthesia or having a family history of allergy to local anesthesia. * Patients with acute oral or facial infection (swelling and/or cellulites )

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scoresBaseline and up to 1 hourVisual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.
Change in child's behaviorDuring the procedureSound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections. Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026