Adverse Events of 4% Articaine in Children below 4 Years of Age: An Observational Study

Aim and background: The use of articaine is well documented in children aged 4 years and above. However, there is a paucity of data concerning its use in children younger than 4 years of age. This study observed the type and severity of adverse events (AEs) that could occur with the use of 4% articaine with 1:1,00,000 epinephrine for supraperiosteal injections in children below 4 years of age. Materials and methods: About 30 children fulfilling the inclusion criteria, requiring supraperiosteal injections for procedures in posterior primary teeth, were observed postinjection of the drug. The procedures that followed the drug administration were classified as “simple” or “complex.” The “type and severity” of the AEs observed were documented according to the methodology by Kalenderian. The World Health Organization–Uppsala Monitoring Centre (WHO-UMC) scale was utilized for the “causality” assessment of the drug. The “preventability” of the AEs was assessed using the modified Schumock and Thornton scale. AEs occurring in “<5 minutes,”“until 60 minutes,” and “up to 24 hours” were recorded. Descriptive statistics and cross-tabulations were done using Pearson’s Chi-squared test, with significance set at p < 0.05. Results: Three children (23.1%) reported pain in the observation time interval “until 60 minutes”. These children had undergone procedures that were classified as “complex.” The p-value was 0.037, which was statistically significant. The AE was categorized as “E1,” which stands for “temporary mild harm to the patient” according to the Kalenderian methodology. The causality term chosen for the AE was “unlikely,” and the AE was classified as “probably preventable.” Conclusion: The findings of this study, within the sample size studied, did not find any AE directly linked to 4% articaine hydrochloride with 1:1,00,000 epinephrine during supraperiosteal injections in children below 4 years of age. Clinical significance: Articaine is not advocated for clinical use in children below 4 years of age.