Propofol or Ketofol for Procedural Sedation and Analgesia in Emergency Medicine—The POKER Study: A Randomized Double-Blind Clinical Trial

Abstract

We determine whether emergency physician-provided deep sedation with 1:1 ketofol versus propofol results in fewer adverse respiratory events requiring physician intervention when used for procedural sedation and analgesia. Consenting patients requiring deep sedation were randomized to receive either ketofol or propofol in a double-blind fashion according to a weight-based dosing schedule. The primary outcome was the occurrence of a respiratory adverse event (desaturation, apnea, or hypoventilation) requiring an intervention by the sedating physician. Secondary outcomes included hypotension and patient satisfaction. Five hundred seventy-three patients were enrolled and randomized, 292 in the propofol group and 281 in the ketofol group. Five percent in the propofol group and 3% in the ketofol group met the primary outcome, an absolute difference of 2% (95% confidence interval [CI] -2% to 5%). Patients receiving propofol were more likely to become hypotensive (8 versus 1%; difference 7%; 95% CI 4% to 10%). Patient satisfaction was very high in both groups (10/10; interquartile range 10 to 10/10), and although the ketofol group was more likely to experience severe emergence delirium (5% versus 2%; difference 3%; 95% CI 0.4% to 6%), they had lower pain scores at 30 minutes postprocedure. Other secondary outcomes were similar between groups. Ketofol and propofol resulted in a similar incidence of adverse respiratory events requiring the intervention of the sedating physician. Although propofol resulted in more hypotension, the clinical relevance of this is questionable, and both agents are associated with high levels of patient satisfaction.