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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05857033
• Other study ID #: 0568-12/2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: May 20, 2023

Study information

• Verified date: April 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Other:
• Buccal 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
• Buccal 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
• Buccal 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
• Buccal 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

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scores	Visual 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.	Baseline and up to 1 hour
Primary	Change in child's behavior	Sound, 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	During the procedure