PURPOSE: The aim of this study was to assess the clinical efficacy of combined treatment with local anesthesia and ketamine procedural sedation for pediatric facial laceration repair in the Emergency Department (ED). METHODS: Patients aged 1 to 5 years receiving ketamine for facial laceration repair were prospectively enrolled in a double-blind, randomized, and controlled study at an ED. All patients were to receive intravenous ketamine (2 mg/kg). The local anesthesia group (LA group) received a local anesthetic along with ketamine, whereas the no local anesthesia group (NLA group) received only ketamine. The total time of sedation, the patients' movements and groans, adverse events, and the satisfaction ratings of physicians, nurses, and parents were recorded. RESULTS: A total of 186 patients were randomized (NLA group: 90, LA group: 96). The total time of sedation (30.5 minutes for the NLA group, 32.6 minutes for the LA group; p=0.660), patients' groans (26 (28.9%) versus 23 (24.0%); 0.446) and movements (27 (30%) versus 35 (36.5%); p=0.350) was not affected by the addition of local anesthesia. Other adverse events were similar between the two groups. Also, the satisfaction ratings of physicians (median 4 for the NLA group versus 4 for the LA group (p=0.796)), nurses (2 versus 2.5 (p=0.400)), and parents (4 versus 4 (p=0.199)) were equivalent between the two groups. CONCLUSION: In this study, we found that local anesthesia was not required along with ketamine sedation for pediatric facial laceration repair.