Efficacy of ethyl chloride topical anesthesia application on pain perception during intra-oral injections in children compared to benzocaine gel-a single-blind randomized controlled trial.

BACKGROUND: Pain management during local anesthesia administration is a critical factor in pediatric dentistry. This assessor-blind, parallel-group, superiority randomized controlled trial (ClinicalTrials.gov: NCT06011005) aimed to determine whether ethyl chloride (EC) spray applied via a cotton pellet provides superior pain reduction compared to 20% benzocaine (BC) gel during intra-oral local anesthetic injections in children. METHODS: Fifty-seven healthy children aged 7-10 years requiring routine dental local anesthesia were randomized to Group A (20% BC gel, n = 29) or Group B (EC spray via cotton pellet, n = 28). The primary outcome was physiological stress measured by change in heart rate (HR). Secondary outcomes included self-reported pain (Faces Pain Scale, FPS) and observed behavioral response (Sound-Eye-Motor scale, SEM). The outcomes assessor was blinded to the topical agent used. Between-group differences in change scores were analyzed using the Mann-Whitney U test with Hodges-Lehmann median differences and bootstrap 95% confidence intervals. RESULTS: Both groups demonstrated slight increases in HR following the injection; however, the magnitude of change was not significantly different between the groups (BC: +4.03 bpm vs. EC: +2.14 bpm; Mann-Whitney U p = 0.310; 95% CI of mean difference: -1.53 to 5.35). Additionally, there were no statistically significant differences between the groups regarding self-reported pain levels (FPS change: BC +1.31 vs. EC +1.25; p = 0.546; 95% CI: -1.03 to 1.08) or behavioral responses (SEM change: BC +0.10 vs. EC +0.11; p = 0.971; 95% CI: -0.22 to 0.21). CONCLUSION: The superiority trial did not reveal a statistically significant difference between the use of ethyl chloride spray and 20% benzocaine gel across any of the measured outcomes. Both anesthetic agents produced comparable physiological responses, self-reported experiences, and behavioral reactions during intra-oral local anesthetic injections in cooperative children aged 7-10 years.