Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.

Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.

The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.

Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Device: Buzzy device (cold and vibration); Device: Buzzy device (vibration only); Other: precooling; Other: Flavored Benzocaine topical anesthetic gel 20%

Detailed Description

The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children in the mixed dentition stage,
• Age range 6-12 years old,
• Need extraction to a maxillary molar,
• Cooperative and medically free.

Exclusion Criteria:

• Exclusion will be performed if the parent refused the participation of their children in the research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buzzy device (cold and vibration)	Device: Buzzy device (cold and vibration); The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction
Experimental: Buzzy device (vibration only)	Device: Buzzy device (vibration only); The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction
Experimental: Precooling	Other: precooling; Ice cubes used for applying coolness at the injection area
Active Comparator: Flavored Benzocaine topical anesthetic gel 20%	Other: Flavored Benzocaine topical anesthetic gel 20%; Topical anesthetic gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported pain during needle injection	Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score	Immediately post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behaviour during needle injection	Child behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score	Immediately during injection
Heart rate	Heart rate was recorded using pulse oximetry (beats/minute)	Immediately post injection
Oxygen saturation	Oxygen saturation was recorded using pulse oximetry	Immediately post injection
Child and parent satisfaction	By asking questions to both child and their parent on a likert scale for children ( positive, neutral and negative) for parents ( strongly agree, agree, no opinion, disagree and strongly disagree)	Immediately post injection

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Fatma KI Abdelgawad, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Local Anesthesia; Buzzy; precooling; Topical Anesthesia
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: CEBD-CU-2023-11-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No