Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department

Abstract

Study objective: We compare the frequency of airway and respiratory adverse events leading to an intervention between propofol with 1:1 and 4:1 mixtures of propofol and ketamine (ketofol).

Methods: We performed a randomized, double-blinded trial in which emergency department adults undergoing deep sedation received propofol, 1:1 propofol and ketamine, or 4:1 propofol and ketamine. Our primary outcome was the frequency of airway and respiratory adverse events leading to an intervention. Other outcomes included sedation depth, efficacy, procedure and recovery time, patient satisfaction, pain, and procedural recall.

Results: Two hundred seventy-one subjects completed the trial, 90 receiving propofol, 85 receiving 1:1 propofol and ketamine, and 96 receiving 4:1 propofol and ketamine. Airway or respiratory adverse events leading to an intervention were similar between groups: 29%, 19%, and 32%, respectively (P=.21). There were no serious adverse events in any group. Secondary outcomes were generally similar between groups, with greater recovery agitation observed in the 1:1 ketofol group (8%, 21%, and 10%, respectively).

Conclusion: We found a similar frequency of airway and respiratory adverse events leading to intervention between propofol alone and either 1:1 or 4:1 ketofol.

Trial registration: ClinicalTrials.gov NCT01260662.