Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial

Buzzy^® - a vibratory unit with ice wings -was introduced to reduce pain induced by needle prick. Objective of the study was to evaluate the effectiveness of "Buzzy^®" in reducing pain perception during administration of maxillary infiltration local anaesthesia compared to the traditional topical anaesthetic gel in pediatric patients. In addition, it aimed to evaluate its effectiveness in intrapapillary anaesthesia in comparison to the conventional palatal injection following buccal infiltration anaesthesia.

Randomized controlled clinical trial with parallel arms. Forty-eight cooperative children aged 6-8 years indicated for maxillary first or second primary molar extractions were selected. They were randomly allocated into 2 main groups (I and II) then into 2 subgroups each (A and B). All groups received buccal infiltration anaesthesia. Group I received local anaesthesia following the use of Buzzy^® extra orally for 2 min. Group II received local anaesthesia following topical anaesthetic gel (benzocaine 20%) intraorally for 1 min. Subgroups A received routine palatal injection whereas subgroups B received intrapapillary anaesthesia. Each patient was videotaped during local anaesthesia injection to objectively assess the reaction using sound, eye, motor scale (SEM). After local anaesthesia administration, pain was subjectively assessed using the visual analogue scale (VAS). Normality was checked in age and VAS using Shaprio Wilk test. The Independent T test was used to compare age between groups. Differences in SEM and VAS between buzzy and infiltration groups were analyzed using the Mann Whitney U test while Wilcoxon sign Rank test was used to analyze the difference in SEM and VAS between intrapapillary and palatal injection within each group. All tests were two tailed and the significance level was set at p value ≤ 0.05.

No statistical significance was observed in pain perception between Buzzy and topical gel regarding buccal local anesthesia. Conversely, objective and subjective statistical significance in pain perception between (Group I) and (Group II) regarding both palatal and intrapapillary anesthesia was recorded.

Applying external cold and vibratory stimulant can reduce pain perception during maxillary buccal, intrapapillary and palatal local infiltration anesthesia.

The clinical registration number in ClinicalTrials.gov holds the identifier: NCT05857033 retrospectively registered on 12/5/2023.