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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06290531
Enrollment
96
Registered
2024-03-04
Start date
2022-01-16
Completion date
2023-09-28
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Children

Keywords

Local Anesthesia, Buzzy, Topical Anesthesia, Pain, precooling

Brief summary

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.

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.

Interventions

DEVICEBuzzy device (cold and vibration)

The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction

DEVICEBuzzy device (vibration only)

The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction

OTHERprecooling

Ice cubes used for applying coolness at the injection area

OTHERFlavored Benzocaine topical anesthetic gel 20%

Topical anesthetic gel

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient reported pain during needle injectionImmediately post injectionPatient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score

Secondary

MeasureTime frameDescription
Heart rateImmediately post injectionHeart rate was recorded using pulse oximetry (beats/minute)
Oxygen saturationImmediately post injectionOxygen saturation was recorded using pulse oximetry
Child behaviour during needle injectionImmediately during injectionChild behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score
Child and parent satisfactionImmediately post injectionBy 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026