NCT05857033

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
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
OTHER	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
OTHER	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
OTHER	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

Timeline

• Start date: 2023-01-05
• Primary completion: 2023-05-20
• Completion: 2023-05-20
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: Egypt