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Completed

NCT Number: NCT06290531

Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Cairo, 11559, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buzzy device (cold and vibration)

Device

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

Buzzy device (vibration only)

Device

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

precooling

Other

Ice cubes used for applying coolness at the injection area

Flavored Benzocaine topical anesthetic gel 20%

Other

Topical anesthetic gel

Primary outcomes

  1. Patient reported pain during needle injection

    Time frame: Immediately post 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

Secondary outcomes

  1. Child behaviour during needle injection

    Time frame: Immediately during injection

    Child behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score

  2. Heart rate

    Time frame: Immediately post injection

    Heart rate was recorded using pulse oximetry (beats/minute)

  3. Oxygen saturation

    Time frame: Immediately post injection

    Oxygen saturation was recorded using pulse oximetry

  4. Child and parent satisfaction

    Time frame: Immediately post injection

    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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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