Needle-free anesthetic polymeric device for dental anesthesia in children: A randomized clinical trial.

Purpose: To evaluate efficacy of an anesthetic mucoadhesive film with a polymeric device (PD) in promoting anesthesia compared to conventional local infiltration (LA) in children.

Methods: 50 children aged 6-10 years (both genders) needing similar procedures on homologous teeth on the maxilla were included. The parents and children were asked about perception of dental treatment. The child's heart rate per minute (bpm) and blood pressure were evaluated before and after each anesthetic technique (AT) procedure. Anesthesia efficacy was measured by reporting pain using Wong-Baker Faces Scale. Children's behavior and AT preferences were also evaluated. Paired T-test, chi-square and Wilcoxon test were used for statistical comparisons.

Results: Fear of anesthesia was reported by 50% of caregivers and by 66% of children. No difference was observed in systolic (P= 0.282) and diastolic (P= 0.251) blood pressure, comparing both AT. Difference was observed regarding the child's behavior when the PD was used (P= 0.0028). Evaluating the face scale, 74% of the children selected the "no pain" (face 0) (P< 0.0001) for PD, and 26% for LA. PD was preferred by 86% of children. Only 20% of the PD anesthesia needed to be complemented by LA.

Clinical significance: The polymeric device presented promising results since most children did not report pain and dental procedures could be performed without local infiltration.