Maimonides Evening of Research
Catsim Fassassi, DO
Comparison of Nebulized Ketamine at Three Different Dosing Regimens for Treating Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind Clinical Trial
Objectives
Methods
This was a prospective, randomized, double-blinded trial comparing three doses of nebulized ketamine (0.75 mg/kg, 1 mg/kg and 1.5 mg/kg) administered via breath-actuated nebulizer, in adult Emergency Department patients aged 18 years and older with moderate to severe acute and chronic pain. Primary outcome included the difference in pain scores between all three groups at 30 minutes. Secondary outcomes included 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 X2 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: NCT03909607.
Results
A total of 120 subjects (40 per group) were enrolled in the study. The mean NRS pain scores at baseline were 8.7, 8.6, and 8.7 (p=NS), and at 30 min were 3.8, 3.4, 3.7 (p=NS). The difference in mean pain scores at 30 minutes between the 0.75 mg/kg and 1 mg/kg groups was 0.25 (95% confidence interval [CI]: -1.28 to 1.78), between the 1 mg/kg and 1.5 mg/kg groups was -0.225 (95% CI: -1.76 to 1.31), and between the 0.75 mg/kg and 1.5 mg/ kg groups was 0.025 (95% CI: -1.51 to 1.56). No clinically concerning changes in vital signs were observed. No serious adverse events occurred in any of the groups.
Conclusion And Implication
There was no difference between all 3 doses of ketamine administered through breath-actuated nebulizer for short-term treatment of moderate to severe pain in the Emergency Department.