RESUMEN
BACKGROUND: Recently, drug combination protocols have been preferred over single drugs in procedural sedation and analgesia (PSA). This study aimed to compare the effectiveness and hemodynamic profile of ketamine-dexmedetomidine (ketodex) and ketofol as drug combinations with ketamine as a single medication for PSA in the emergency department (ED). METHODS: This prospective, randomized, double-blind clinical trial was performed among adult patients (≥18 years) requiring PSA for a painful procedure in the ED. 135 patients were enrolled and assigned into three equal groups to receive either ketodex, ketofol, or ketamine. Additional ketamine was used as a rescue agent for inadequate sedation in three groups. Oxygen saturation, heart rate, and blood pressure were recorded from baseline until 120 min after induction of PSA. Adverse events, hemodynamic variables, induction, and recovery time were recorded and compared between groups. RESULTS: The mean age of the patients was 38.16 ± 19.09 years and no differences were observed between the three groups in terms of demographic variables, pain scores, and procedures between the three groups. Respiratory events had similar incidences between the three groups. The O2 reduction was less in the Ketodex group in comparison with Ketofol and Ketamine groups (1.9%, 6.5%, and 3.8%, P = 0.015). No patient needed endotracheal intubation. Changes in mean arterial pressure from the baseline in Ketamine and Ketofol groups compared to Ketodex was higher (difference was 12.9 mmHg [95% CI, 9.5 to 20.3] and 8.6 mmHg [95% CI, 3.4 to 13.7]. Tachycardia in the Ketamine group had a significantly higher incidence. The recovery time was statistically shorter in the Ketofol group in comparison with other groups. The differences between Ketofol with Ketamine and Ketodex groups were 9.8 min (95% CI, [2.5 to 17.1]) and 8.3 min (95% CI, [1.5 to 15.1]). CONCLUSION: Ketodex, as well as ketofol, were effective and safe combinations with good recovery profiles and hemodynamic stability for adult PSA in ED.