Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial.

BACKGROUND: Pain control is a mandatory aspect in pediatric dentistry office through local anesthesia.

AIM: To assess the safety and efficacy of 4% articaine local anesthetic in young children below four years old.

DESIGN: An equivalent randomized control trial with two parallel arms included 184 young children (92 per group) aged from 36 to 47 months seeking pulpotomy of mandibular primary molars which performed after buccal infiltration injection. The control group received lidocaine hydrochloride 2% with epinephrine 1:100 000. The intervention was articaine hydrochloride 4% with epinephrine 1:100 000. Children's behavior during injection and treatment have assessed using Faces, Legs, Activity, Cry, and Consolability (FLACC) and child's behavior using Frankl Behavior Rating Scale (FBRS). In addition, post-operative complications have been addressed.

RESULTS: Both anesthetic agents were equivalent during the injection phase. During the treatment phase, the absolute risk difference (ARR) between the two groups was 0.120 (95% CI: -0.003; 0.243). The maximum limit of 95% CI surpassed the margin of equivalence, indicating that less pain has been expressed during pulpotomy among children delivered articaine when compared to their counterparts in the lidocaine group. Concerning post-operative complications, no statistically significant difference was detected between the two anesthetic drugs.

CONCLUSION: The findings supported the efficient and secure use of articaine hydrochloride 4% with epinephrine 1:100 000 to treat children between the ages of 3 and below 4 years old.