An interventional study of Buccal and direct palatal injection with the aid of Buzzy and Buccal and indirect palatal injection with the aid of Buzzy in Anesthesia, Local, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Alexandria University · Not applicable, Interventional, and Other
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.
Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Other: Buccal and direct palatal injection with the aid of Buzzy
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
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection
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.
Time frame: Baseline and up to 1 hour
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
Time frame: During the procedure
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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