Dexmedetomidine-ketamine and midazolam-ketamine combinations for sedation in pediatric patients undergoing extracorporeal shock wave lithotripsy: a randomized prospective study.

PURPOSE: Extracorporeal shock wave lithotripsy (ESWL) requires sedation in pediatric patients. Dexmedetomidine is a relatively new agent used for sedation. The aim of this randomized prospective study was to compare the effects of dexmedetomidine-ketamine and midazolam-ketamine combinations on the recovery time, hemodynamic and respiratory variables, and side effects in pediatric patients undergoing ESWL.
METHODS: Fifty pediatric patients aged between 2 and 15 years who were scheduled for elective ESWL were randomized into two groups. In Group D we applied dexmedetomidine at1 μg/kg, given over 10 min, and a bolus of 1 mg/kg ketamine for sedation. In Group M we applied midazolam at a 0.05 mg/kg bolus dose 10 min before the procedure and a 1 mg/kg bolus of ketamine. We measured and monitored the hemodynamic variables, oxygen saturation, and recovery time, and we also monitored the side effects.
RESULTS: Four patients in group D refused to complete the study; 21 patients in group D and 25 patients in group M completed the study. We found the recovery time [eye-opening time (9.3 ± 4.5 vs. 16.2 ± 6.5 min; p < 0.001), verbal response time (12.8 ± 4.9 vs. 19.2 ± 7.2 min; p < 0.001), and the cooperation time (17.1 ± 5.0 vs. 23.3 ± 7.7 min; p < 0.001)] to be shorter in the dexmedetomidine group. Also, the heart rate values were lower in the dexmedetomidine group at the 20th minute of the procedure (99.1 ± 19.0 vs. 118.7 ± 7.3 beats/min; p = 0.016).
CONCLUSION: In this study we found the recovery time to be shorter, with hemodynamic stability, in the dexmedetomidine group, compared with the midazolam group. So we can conclude that dexmedetomidine may be a good and safe alternative agent for sedation, with a shorter recovery period than midazolam, in the pediatric population.

RCT Entities:   Population Interventions Outcomes