Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention A: Buzzy® Bee-Assisted Local Anesthesia: Behavioral Guidance: Child preparation using the Tell-Show-Do technique. Device Application: The Buzzy® Bee device (equipped with pre-frozen wings) is activated to provide combined high-frequency vibration and cryotherapy. It is placed on the extraoral cheek skin approximately 1-2 cm proximal to the target injection site for 30 seconds prior to needle insertion and remains continuously active throughout needle insertion and solution deposition. Topical Anesthesia: Injection site is isolated with cotton rolls, dried, and treated with 2% Lidocaine gel applied for 2 minutes via a sterile cotton swab. Local Anesthesia Injection: Maxillary buccal infiltration is delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds while Buzzy® Bee is running.

Intervention B: Conventional Local Anesthesia Technique: Behavioral Guidance: Child preparation using standard Tell-Show-Do behavioral guidance paired with routine audiovisual distraction (cartoons displayed on a chair-side screen). Topical Anesthesia: Identical protocol to Intervention A (site isolation, drying, and 2% Lidocaine gel application for 2 minutes). Local Anesthesia Injection: Maxillary buccal infiltration delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds using identical technique, volume, and rate as Intervention A, but without external vibration or cryotherapy application.

Study summary

The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.

Eligibility

Primary outcome measure(s)

• Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale) — Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)
  Subjective pain intensity assessed using the validated Wong-Baker FACES® Pain Rating Scale. The scale features six facial expressions ranging from 0 ("No Hurt") to 10 ("Hurts Worst") in increments of 2 (0, 2, 4, 6, 8, 10). Following local anesthesia administration, the child is seated upright and points to the face that best represents their pain intensity experienced during needle insertion. Higher scores represent higher pain intensity.

Trial sites (1)

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