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

Alexandria University

Status: Active, not recruiting

Conditions: Anesthesia, Local

Treatments: Other: Buccal and indirect palatal injection with the aid of Buzzy; Other: Buccal and direct palatal injection without Buzzy; Other: Buccal and indirect palatal injection without Buzzy; Other: Buccal and direct palatal injection with the aid of Buzzy

Study type: Interventional

Funder types: Other

Identifiers

NCT05857033

0568-12/2022

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Direct local anesthesia with Buzzy

Experimental group

Treatment:

Other: Buccal and direct palatal injection with the aid of Buzzy

Indirect local anesthesia with Buzzy

Experimental group

Treatment:

Other: Buccal and indirect palatal injection with the aid of Buzzy

Direct local anesthesia

Active Comparator group

Treatment:

Other: Buccal and direct palatal injection without Buzzy

Indirect local anesthesia

Active Comparator group

Treatment:

Other: Buccal and indirect palatal injection without Buzzy