Randomized clinical trial of propofol versus alfentanil for moderate procedural sedation in the emergency department James R. Miner, MD ⁎, Brian E. Driver, MD, Johanna C. Moore, MD, Erik Faegerstrom, Lauren Klein, MD, Matthew Prekker, MD, MPH, Jon B. Cole, MD Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, United States abstract article info Article history: Received 30 January 2017 Received in revised form 18 April 2017 Accepted 19 April 2017 Available online xxxx Study objective: To compare the frequency of airway and respiratory adverse events leading to an intervention between moderate sedation using alfentanil or propofol. Methods: We performed a randomized clinical trial in which adults undergoing moderate sedation in the ED re- ceived either alfentanil or propofol. Our primary outcome was the frequency of airway and respiratory adverse events leading to an intervention. Other outcomes included sedation depth, efficacy, sedation time, patient sat- isfaction, pain, and satisfaction. Results: 108 subjects completed the trial: 52 receiving alfentanil and 56 receiving propofol. Airway or respiratory adverse events leading to an intervention were similar between the two groups: 23% for alfentanil and 20% for propofol (p = 0.657). There were no serious adverse events in any group. Secondary outcomes were notably dif- ferent in the rate of reported pain (48% for alfentanil, 13% for propofol) and recall (75% for alfentanil, 23% for propofol) and similar in the rate of satisfaction with the procedure (87% for alfentanil, 84% for propofol). Conclusion: We found a similar frequency of airway and respiratory adverse events leading to intervention be- tween alfentanil and propofol used for moderate procedural sedation. Both agents appear safe for moderate pro- cedural sedation. © 2017 Elsevier Inc. All rights reserved. Keywords: Moderate procedural sedation Procedural sedation Emergency medicine Emergency department Propofol Alfentanil Adverse respiratory events 1. Introduction Moderate procedural sedation refers to the use of an analgesic and/ or amnestic sedative/hypnotic agent to produce a sedated state for a procedure from which a patient can be aroused with voice or light touch. Deep sedation refers to patients that have been sedated to a level in which they respond to painful stimulus, but not voice or light touch. Both levels have been described frequently for procedural seda- tion with a variety of agents [1-8]. Previous research has shown that using a target of moderate rather than deep sedation can lead to a lower rate of sub clinical respiratory de- pression [1]. However, it has also been shown that targeting moderate sedation frequently results in deep sedation [1,4,9]. It has not been shown whether using an agent typically associated with moderate se- dation, such as an opioid, would result in less frequent adverse events than using an agent more typically associated with deep sedation, such as propofol, when they were both used with a target of moderate sedation. Propofol is frequently used for both moderate and deep procedural sedation in the ED, although it is most frequently described for deep se- dation. Propofol produces sedation, hypnosis, and dense amnesia. It has an adverse effect rate of 5% in ED patients, with transient hypoxia occur- ring in 5%–30% of sedations [8-12]. Amnesia from propofol has been de- scribed as lasting 15.7 min in patients who have received 1 mg/kg IV bolus followed by 0.5 mg/kg until sedation is achieved [13]. Patients se- dated with these doses often demonstrate responses to pain during the procedure they do not later recall. Such a response is in fact the defining characteristic of deep sedation relative to general anesthesia. Patients sedated at this dose of propofol have also been described to continue to respond to voice and answer questions, consistent with the descrip- tion of moderate sedation and indicating that this dose of propofol likely achieves amnesia with when either moderate or deep sedation is achieved [13] [7-9,11,14-17]. Alfentanil is an ultra-short acting opioid and an effective analgesic that is also described for the induction of moderate sedation [18]. It in- duces 7 to 9 min of analgesia after a bolus of 10 μg/kg, which is a similar duration as that of propofol [18]. Studies of alfentanil sedation have shown that use of the agent alone results in lower rates of hypoxia that those reported for alfentanil combined with other sedative agents [18-21]. Both alfentanil and propofol are used for moderate procedural sedation frequently and have been shown to be safe [7,9,10,18-21]. American Journal of Emergency Medicine xxx (2017) xxx–xxx ⁎ Corresponding author at: Department of Emergency Medicine, Hennepin County Medical Center, 701 Park Avenue South, Minneapolis, MN 55415, United States. E-mail address: Miner015@umn.edu (J.R. Miner). YAJEM-56636; No of Pages 6 http://dx.doi.org/10.1016/j.ajem.2017.04.041 0735-6757/© 2017 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect American Journal of Emergency Medicine journal homepage: www.elsevier.com/locate/ajem Please cite this article as: Miner JR, et al, Randomized clinical trial of propofol versus alfentanil for moderate procedural sedation in the emergency department, American Journal of Emergency Medicine (2017), http://dx.doi.org/10.1016/j.ajem.2017.04.041