OBJECTIVE: Currently, there are no clinical trials evaluating the role of nebulized ketamine in managing pain in the Pediatric ED. Our aim was to assess and compare the analgesic efficacy and rates of adverse effects of ketamine administered via breath-actuated nebulizer at three different dosing regimens (0.75mg/kg, 1 mg/kg, and 1.5 mg/kg) for Emergency Department pediatric patients presenting with acute and chronic painful conditions.

METHODS: This is a prospective, randomized, double-blinded trial comparing three doses of nebulized ketamine (0.75mg/kg, 1 mg/kg, and 1.5 mg/kg) administered via breath-actuated nebulizer, in Pediatric Emergency Department for patients aged 7-17 years old with moderate to severe acute pain. Primary outcomes include the difference in pain scores between all three groups at 30 minutes. Secondary outcomes include a need for a second or third dose of ketamine, need for rescue analgesia, and adverse events in each group at 30 and 60 minutes. ANOVA and χ _2 test were used for data analysis. Power analyses indicated the need for 120 patients (40 in each group). The study is registered with www.clinicaltrials.gov; ID: NCT03950817.

RESULTS: A total of 80 subjects, among the three groups, were enrolled in the study. The mean NRS pain scores at baseline are 7.65, 7.89, and 7.81 (p=.71), and at 30 min were 3.65, 4.0, and 43.63 (p=.65). The difference in mean pain scores at 30 minutes between the 0.75 mg/kg and 1 mg/kg groups is 0.20 (95% confidence interval [CI]:-1.34 to 1.75); between the 1 mg/kg and 1.5 mg/kg groups is -0.33 (95% CI: -1.74 to 1.09); and between the 0.75 mg/kg and 1.5 mg/kg groups is -0.13 (95% confidence interval [CI]: -1.35 to 1.10). No clinically concerning changes in vital signs were observed. No serious adverse events occurred in any of the groups.

CONCLUSION AND IMPLICATIONS: There was no difference between all three doses of ketamine administered through breath-actuated nebulizer for short-term treatment of moderate to severe pain in the Pediatric Emergency Department.