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

H Ananthu1, Ashwin P Rao2, Ashwin Kamath3

  • 1Department of Pediatric and Preventive Dentistry, NITTE (Deemed to be University), AB Shetty Memorial Institute of Dental Sciences (ABSMIDS), Mangaluru, India.

International Journal of Clinical Pediatric Dentistry
|December 2, 2025
PubMed

Insights

This study found no adverse events directly linked to 4% articaine with epinephrine in children under 4 years old. However, caution is advised as articaine is not typically recommended for this age group.

Area of Science:

  • Pediatric Dentistry
  • Pharmacology
  • Anesthesiology

Background:

  • Limited data exists on the use of articaine in children under 4 years old.
  • This study addresses the safety of 4% articaine with 1:1,000,000 epinephrine for supraperiosteal injections in this age group.

Purpose of the Study:

  • To observe the type and severity of adverse events (AEs) associated with 4% articaine and epinephrine in children under 4 years of age.
  • To evaluate the causality and preventability of any observed AEs.

Main Methods:

  • An observational study involving approximately 30 children under 4 years old requiring supraperiosteal injections.
  • AEs were documented using the Kalenderian methodology and causality assessed with the WHO-UMC scale.
  • Preventability was assessed using the modified Schumock and Thornton scale.

Main Results:

  • Three children (23.1%) experienced temporary mild pain during complex procedures within 60 minutes post-injection.
  • The pain was classified as "unlikely" in causality and "probably preventable."
  • No other AEs were directly linked to the anesthetic in the observed timeframe.

Conclusions:

  • The study did not find direct adverse events linked to 4% articaine with epinephrine in children under 4 years.
  • Despite findings, articaine is not currently advocated for clinical use in children under 4 years old.
Abstract

Keywords:
ArticaineChildrenPain

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