Original article 407

Emergency department procedural sedation: the London experience Samer M. Elkhodaira, Elinor C. Bakerb, Will R. Glasebrookc, Jason D. Pottb, Yonathan Freundb and Tim R. Harrisb Aim The aim of this study was to develop a procedural sedation guideline and an audit tool to identify the medications chosen, the incidence of predefined adverse events and the factors associated with their occurrence.

clinical evidence of aspiration and no patient required intubation. Procedural success was 96%. Propofol was associated with fewer adverse events (95% confidence interval: 0.024–0.572), as well as higher procedural success.

Methods We performed a prospective observational study using a standardized proforma. We obtained data on patient demographics, the procedure performed, the drugs used and the dosages and predefined adverse events. Our target population was adult patients attending three urban UK teaching hospital Emergency Departments (EDs) over a 12-month period. We included all patients who were to undergo procedural sedation in the ED.

Conclusion Procedural sedation and analgesia can be safely and effectively performed in the ED by appropriately trained emergency physicians. European Journal of Emergency Medicine 22:407–412 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Results Data were obtained on 414 patients. The majority of procedures were reductions of fractures and dislocations (89%). Midazolam was the sedative agent used most commonly (45%), and morphine was the most frequently used analgesic agent (36%). Overall 10% of sedations involved predefined complications (95% confidence interval: 7.1–12.9). There were no cases of airway obstruction requiring intervention; no patients showed

Introduction Painful procedures are commonly performed in the Emergency Department (ED). ED-based procedural sedation and analgesia (PSA) has an excellent safety profile when performed by trained emergency physicians [1–5]. PSA allows a wide range of procedures to be performed with minimal discomfort and with cardiorespiratory function remaining intact or minimally depressed [6–8]. Analgesia and sedation are offered to improve both the patient experience and the probability of procedural success. A wide range of agents are available with differing properties and popularities. The role of propofol (2,6-diisopropylphenol) in ED procedural sedation was first described in 1996, and it has rapidly gained popularity [9]. Over the past decade, there has been a trend toward using propofol as a shorter acting agent to facilitate an appropriate level of sedation [1,3,4,10]. Propofol is said to be associated with lower rates of postprocedural resedation compared with widely used conventional benzodiazepines [11]. However concerns have been raised about the potential risks of propofol, in particular deeper-than-anticipated sedation with potential increases in adverse physiological events, such as hypoventilation, hypoxia and upper airway obstruction [12–15]. There is a paucity of European literature 0969-9546 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

European Journal of Emergency Medicine 2015, 22:407–412 Keywords: conscious sedation, procedural sedation, propofol, sedation a Emergency Department, University College London Hospital , bEmergency Department, Barts Health NHS Trust, Royal London Hospital and cEmergency Department, St Georges Health Care, London, UK

Correspondence to Samer M. Elkhodair, MD, MRCS Ed, MFAEM, FCEM, Emergency Department Offices, UCLH, 250 Euston Rd, East Wing, 4th Floor, London NW1 0PG, UK Tel: + 44 20 3447 8439; fax: + 44 20 3447 9610; e-mail: [email protected] Received 9 November 2013 Accepted 16 July 2014

describing sedation practice, choice of medication and adverse events, with most data being reported from single sites. We set out to describe the medications used for procedural sedation and to evaluate complication rates by collecting data on a-priori defined adverse events for 12 months from three large urban hospitals, following the introduction of a standardized sedation guideline. We also set out to compare adverse events for different PSA regimes chosen by the emergency physician.

Methods We developed and introduced a procedural sedation guideline and combined a data collection tool in three EDs. Data were obtained on all patients undergoing PSA within a 12-month period. The guideline was based on existing published literature. It stresses on procedural sedation being performed as a two-step process, with the analgesic agents being administered in step one and procedural sedation being performed in step two, once suitable analgesia is obtained. It does not mandate a particular analgesic or sedative agent, but emphasizes the importance of familiarity with the medications DOI: 10.1097/MEJ.0000000000000197

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administered as key to safety. The guideline defines three levels of sedation as follows: Level 1: analgesia and anxiolysis without sedation – nitrous oxide, intravenous opiates titrated to effect. Level 2: analgesia and sedation with medications that can cause minimal impairment of cardiorespiratory and laryngeal reflexes – ketamine in a dose range of 0.5–1 mg/kg. Level 3: procedural sedation using medications that may impair cardiorespiratory drive and laryngeal protective reflexes – 0.05–0.1 mg/kg midazolam, 0.5 mg/kg propofol and 0.1 mg/kg etomidate, titrated to effect using repeat boli of half the initial dose. Analgesia is provided with intravenous morphine or fentanyl in 2.5 mg/25 mcg boli, respectively, titrated to effect. Doses of analgesia and sedation medications are halved in elderly patients (>65 years) and in those with unstable tachyarrhythmias for cardioversion. The guideline defines patient selection using the American Society Anaesthesiologists (ASA) physical status classification system, limiting ED sedation to patients with ASA I or II grades, those who have unstable tachyarrhythmias requiring urgent cardioversion or patients with severe trauma requiring immediate intervention. The guideline defines the roles and number of staff required to perform procedural sedation (one doctor to perform the procedure, one doctor to perform the sedation and an emergency nurse), the place for the procedure (resuscitation room or dedicated procedure room with wall oxygen, wall suction and tilting trolley), as well as the level of monitoring required (noninvasive blood pressure every 3–5 min, end tidal capnography, five lead ECG, respiratory rate and oxygen saturation). All patients received supplemental oxygen through a Hudson or nonrebreathing mask at 8–15 l/min, and the trolley was set angled to 30° head up to maximize ventilatory mechanics. The training level of staff is also defined, with a minimum of 3 months anaesthesia or intensive care training required for the use of ketamine and 6 months for the use of propofol or etomidate. All doctors are required to have read the guideline and undergone supervised training with sign-off by a senior emergency physician after a minimum of five completed sedation procedures.

Study population and setting

This study was conducted at the EDs of three urban, academic centres with a combined census of over 300 000 ED visits annually. Data were obtained on consecutive adult (≥17 years of age) patients undergoing PSA. The emergency physician providing sedation was responsible for the preprocedure assessment, sedation plan, dosing of the medication and monitoring of the

patient. The frequency and incremental dosing of sedative agents was at the discretion of the individual treating physician. No scoring of the sedation level of pain was performed. Data collection

Data were collected for all patients undergoing PSA during the period between October 2011 and October 2012. The sedation guideline incorporates a common data collection tool, thus ensuring standardized data collection at the time of the procedure and reporting between sites. This includes guided assessment, ASA score, staffing, fasting status, monitoring used, sedation and analgesic doses, physiology, defined adverse events and type of procedure performed. Data analysis

The data from the standardized audit tool were entered into a database (Microsoft Excel; Microsoft, Bellevue, Seattle, USA; 2010) for further analysis. Mean and SD were used to summarize Gaussian distributed variables (mean ± SD), median and their interquartile range for non-Gaussian distributed variables, whereas the frequency and percentage of occurrence were used to summarize categorical variables. Odds ratios and their 95% confidence intervals (CIs) were calculated for associated univariate variables. Statistical significance was defined as P less than 0.05; all analyses were two-tailed. Statistical analyses were carried out using SPSS version 21.0 (IBM SPSS, Chicago, Illinois, USA). The study was reviewed by the regional ethics committee, classified as an audit and registered according to the local guidelines.

Results Overall 414 data collection forms were submitted, and all patients were included in the analysis. Some data were incomplete. A-priori defined adverse events are reported in Table 1. Basic patient and sedation characteristics are summarized in Table 2. The mean age of the patients was 43 years. The majority of the PSAs were performed on ASA I/II patients (272 = 69%, 103 = 26%, respectively). Most commonly, PSA was carried out for an orthopaedic procedure (89% of all sedations) and by doctors with more than 5 years of postgraduate experience (71%, specialists or higher trainees in Emergency Medicine, as defined in Table 2). Overall, there were 55 adverse events, concerning 42 PSAs (10% of all cases, 95% CI: 7.1–12.9; Table 3). Table 4 lists the sedative/ analgesic agents used with their doses and associated adverse events (including procedural failure). Table 5 shows the incidence of adverse events in relation to the sedative agent used to achieve the procedural sedation. Propofol was independently associated with a lesser incidence of adverse events, with an odds ratio of 0.117 (95% CI: 0.02–0.57, P = 0.008).

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Procedural sedation Elkhodair et al. 409

Table 1

Prospectively defined adverse events

Adverse events

Details

Laryngospasm Airway obstruction Aspiration Hypoventilation Hypoxia Hypotension Tachyarrhythmia or bradyarrhythmia Emergence phenomena Emesis Allergic reaction Death Other

Partial or complete airway obstruction with oxygen desaturation caused by sustained adduction of the vocal cords Stridor, with or without obstructed respiration due to loss of upper airway tone requiring airway manoeuvres/simple gadgets Emesis or reflux from mouth or nose during sedation and subsequent decrease in oxygen saturation by 5% from baseline, with new chest radiographic airspace shadowing Fall in respiratory rate sufficient to warrant bag valve ventilation or specific reversal agent Apnoea – cessation of ventilation with no respiratory effort visible on ET CO2 trace SpO2 < 92% SBP < 90 or > 40 mmHg from baseline New atrial flutter/fibrillation, bradycardia < 40 beats/min, broad complex tachycardia Distressing visual or auditory hallucinations highlighted by patient or observed by staff Postprocedure vomiting before discharge from hospital Any rash, bronchospasm, angio-oedema or hypotension caused by administration of medication used in procedural sedation During procedure or after procedure, before discharge from the ED Free text data field to incorporate any adverse events noted by staff

ED, emergency department; ET, end tidal; SBP, systolic blood pressure.

Table 2

Patient and sedation characteristics Number recorded (N = 414)

Patient characteristics Mean age (years) Mean weight (kg) ASA I II III IV Sedation characteristics Procedure Reduction of a dislocation Manipulation of a fracture Cardioversion Incision and drainage Chest drain insertion Imaging Other Sedationist Consultant/specialist (qualified emergency physician) Registrar ST 4–6; (advanced trainee in emergency medicine with > 5 years experience in emergency medicine/ anaesthesia/intensive care medicine Core trainee: basic trainee in emergency medicine with > 18 months emergency medicine/anaesthesia/intensive care medicine and > 12 months additional medical experience Others

414 305 395

N (%) or mean (± SD)N 43.4 (± 20.2) 75.2 (± 17.1) 272 103 18 2

(69) (26) (5) (1)

414 283 87 14 11 5

(68) (21) (3) (3) (1) 2 12 (3)

392 135 (34)

international literature, which suggests that in North America and Australasia, propofol is the most commonly used agent [1,4,10,14,16–18]. In our study, propofol was used in 27% of all PSAs as a single agent and in 6% in combination with a ketamine. In a recent New Zealand study of 313 adults, Harvey et al. [4] reported that 99% of their cohort was sedated with propofol. A 2006 Canadian study reported that propofol was used in 84% of 160 consecutive sedations [3]. Two recent UK studies have described series with propofol-based and ketamine-based PSA; hence, the practice in the UK may be changing from benzodiazepine-based sedation [19,20]. In keeping with previous work, this study reinforces the excellent safety profile of propofol in the hands of emergency physicians [1,9–11,19–21]. The mean propofol dose in our study was 1.17 mg/kg. This is also lower than figures reported by many previous authors, with most authors reporting a total dose of 1.5–1.8 mg/kg [1,20,22,23].

145 (37)

100 (26)

12 (3)

ASA, American Society Anaesthesiologists.

Discussion This is the largest multisite cohort study reported from the UK to date, and it reveals an encouraging safety profile. We found no serious adverse events such as apnoea, arrhythmia or requirement for intubation. One patient had transient laryngospasm, which was managed conservatively. In our study, midazolam was the most commonly used medication for PSA. This is in keeping with the findings of the largest (single-centre) UK study to date in which 70% (982/1402) patients received midazolam as their sole sedative agent as compared with 22% (307/1402) receiving propofol [13]. This differs from the reported

We identified a low rate of cardiorespiratory complications (13 respiratory events and two haemodynamic events; 3.3 and 0.48%, respectively, of all PSAs performed). Our study adds to the large body of evidence that suggests that PSA may be performed safely in the ED by emergency physicians [1,3,4,10,13,15,16,18,20]. Similar to the published literature, simple airway manoeuvres, bag valve mask ventilation, intravenous fluids and agent-specific reversal medications were the only interventions required in this series [4,10,15,20,21,24]. We used small titrated boli of opiate analgesics, administered before procedural sedation. This may have reduced the total dose of sedation required. Our guideline also suggests lower initial and repeat doses of the sedative agent as compared with many previous studies. This may also have had an impact on the low rate of respiratory adverse events. In our study, the initial propofol dose was 0.5 mg/kg and further boli were titrated at 0.25 mg/kg. Similar dosing regimens to those reported in our study have been described in previous work. Those studies have also concluded that small boli of sedatives are associated with fewer cardiorespiratory adverse events

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410 European Journal of Emergency Medicine 2015, Vol 22 No 6

Table 3

Observed adverse events and associated medications

Adverse event

Number

Laryngospasm Airway obstruction Aspiration Apnoea Hypoventilation

1 0 0 1 7

Hypoxia (SpO2 < 92%) Hypotension Bradycardia or tachycardia Emergence phenomena

4 2 0 6

Rigiditya Nausea and vomiting Need for rescue drugs Death Other Inadequate sedation Over sedationa Allergic reaction Hypertension – SBP > 180 mmHga Totalb

1 5 7 0 1 1 2 2 55

Drug(s): number of occurrences Ketamine alone

Morphine and midazolam Fentanyl, ketafol: 1, midazolam alone: 1, midazolam, fentanyl: 2, morphine, ketamine: 1, morphine, propofol: 1, ketamine alone: 1 Ketamine alone: 2, fentanyl, midazolam: 1, morphine, ketamine: 1 Fentanyl, midazolam: 1, midazolam alone: 1 Ketamine and propofol: 1, ketamine and midazolam: 2, morphine, ketamine: 1, morphine, ketamine, midazolam: 1, ketamine alone: 1 Fentanyl, ketamine, propofol Ketamine and midazolam: 2, midazolam and morphine: 2, ketamine alone: 1 Flumazenil given: 3 (midazolam alone), naloxone given: 4 (fentanyl, midazolam: 3; fentanyl, morphine, midazolam: 1)

Morphine, midazolam Midazolam alone Ketamine, midazolam: 2 Morphine, ketamine, midazolam: 2

SBP, systolic blood pressure. These were not a-priori defined adverse events but were noted on the sedation record by the practitioner. Agent-specific reversal was not carried out for oversedation. Possiblity of having more than one event per sedation.

a

b

Table 4

Sedative/analgesic agents used with doses and associated adverse events (including procedural failure, N = 414) Drug

Sedative agents

Number of sedations (% of patients)a

Ketamine Propofol Ketafolb Midazolam Morphine Fentanyl Entonox

Analgesic agents

84 110 24 186 151 132 5

(20) (27) (6) (45) (36) (32) (1)

Median dose (IQR)

Adverse events per drug (% times used)

0.92 mg/kg (0.54–1.38) 1.17 mg/kg (1–1.67) 0.9 mg/kg (0.3–1.9) 0.05 mg/kg (0.03–0.07) 0.10 mg/kg (0.07–0.13) 1 mcg/kg (0.78–1.25) NA

16 3 3 20 14 10

(19) (3) (13) (11) (9) (8) 0

IQR, interquartile range. Sedative agents: three patients were given no sedative, two patients were given diazepam for sedation, one patient was given etomidate and four patients had missing data. Analgesic agents: possibility of receiving no analgesia or multiple drugs. b 5 mg/ml of both ketamine and propofol. a

Type of sedative and adverse events: univariate analysis (note subtotals vary because of incomplete data)

Table 5

95% CI

Opiate Sedatives Midazolam Propofol

Adverse event [N (%)]

No adverse event [N (%)]

OR

20 (11) 3 (3)

166 (89) 105 (97)

1.675 0.117

Lower Upper P-value 0.692 0.024

4.051 0.572

0.253 0.008

CI, confidence interval; OR, odds ratio.

and more rapid recovery [15,16]. Weaver et al. [15] used an initial propofol bolus of 0.5 mg/kg (mean cumulative dose of 1.5 mg/kg), with 11% (of 82) patients reported as hypoxemic (defined as respiratory rate < 6 breaths/min) and four patients requiring intervention. Indeed, Ducharme [25] has suggested repeated small boli of propofol being delivered and titrated to effect as a safer regime. This hypothesis is yet to be explored. Previous authors have recommended an initial dose of 1 mg/kg, followed by 0.5 mg/kg as required; indeed this is the regime supported by the ACEM 2007 Clinical Practice

Advisory [16,17,21]. Using the regime recommended by ACEM, Mensour et al. [3] reported a 10% rate of apnoea and a 1% rate of hypotension, and Taylor et al. [22] identified a hypoxia rate of 22.9% (defined as oximetry reading < 92%). It is evident that the incidence of cardiorespiratory depression and postprocedural sedation is linked to both the rate and the dose of drug administration [16,17,23,26]. However, the observational nature of this study does not allow for any conclusions to be drawn from these findings. Previous trials have identified similar cardiorespiratory complications with propofol, etomidate and midazolam [11,13,22,27–29]. In our study the mean total dose of ketamine was 0.92 mg/kg (range 0.3–1.9 mg/kg), which is in keeping with previously reported data. Miner et al. [18] reported a total ketamine dose of 1.0 mg/kg (range 0.85–3.00). Newton and Fitton [19] reported a mean dose of ketamine of 0.7 mg/kg (range 0.5–1.0) administered in 0.5 mg/kg aliquots. Published series allowing clinicians to choose their preferred sedative agent suggest that propofol is a more popular agent than ketamine in adult PSA [3,10].

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Procedural sedation Elkhodair et al. 411

Seniority of the sedationist and incidence of adverse events

Summary

Table 6

Variable Grade Consultant Registrar ST 4–6 Core trainee

Adverse event [N (%)]

No. adverse events [N (%)]

P-value

18 (13) 10 (7) 12 (12)

117 (87) 135 (93) 88 (88)

0.630 0.190 0.574

Our procedural success rate was 96.4% (failure rate 3.6%, 15 cases), which compares favourably with other papers, with a failure rate ranging from 1 to 21% [3–5,19,30–32]. The largest published study on ED procedural sedation reported to date suggests that procedural failure is lowest with ketamine used as a single agent and highest with propofol [30]. The authors note that these two drugs were used in different age groups and for different procedures, with ketamine used most often in paediatric sedation and propofol used frequently for dislocated hip prosthesis in adults, a procedure associated with a high failure rate in the ED.

The low complication rate (10%, 95% CI: 7.1–12.9%) and rarity of serious adverse events reported in this study are supportive of the emerging consensus that PSA can be carried out safely and effectively by appropriately trained emergency physicians. Our study adds to two single-centre UK studies (1008 and 1402 patients), providing evidence that procedural sedation in the UK is similarly safe to Australasian and North American practices [13,20]. Further studies should include more comprehensive reporting of drug doses and monitoring practices. Agreement on standardized reporting for adverse events would facilitate research, learning and safe practice. A national database may provide important data on the relative safety and procedural success associated with individual agents. The College of Emergency Medicine has recently published national guidelines, which are very similar to the guidelines described and audited in this paper. These have been widely adopted by the sedation community of our Hospitals [7].

Acknowledgements In this study the majority of PSAs were performed for orthopaedic procedures. This finding is similar to those of previous studies [1,3–5,13,16]. Our data include fewer cardioversion PSAs (14/3%) than the majority of previous work. Burton et al. [1] reported a figure of 10% in their series involving 792 patients undergoing PSA, and Willman and Andolfatto [33] reported a rate of 7.9%. A recent UK series included 9% of PSAs for cardioversion [20]. This likely suggests that many patients in our region with acute myocardial ischaemia and broad complex tachycardia are transferred directly to specialist cardiology centres. It may also suggest that UK emergency physicians are conservative in treating new onset atrial fibrillation, choosing pharmacological cardioversion or observation as opposed to electrical cardioversion.

Conflicts of interest

There are no conflicts of interest.

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We found no association between the seniority of the doctor performing the sedation and the incidence of adverse events (Table 6). This is in keeping with previous UK literature [13].

7

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Limitations

This is a small study with few adverse events and consequently limited statistical power. The inconsistent data completion seen in this study will be rectified with further training on sedation, improved governance and full integration of the data collection tool into patient care. This study was observational and hence was not designed to test any hypothesis. As such, associations between adverse events and operator or medication choices are viewed only as hypothesis-generating. The data collected were self-reported and as such are impossible to validate.

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14

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Emergency department procedural sedation: the London experience.

The aim of this study was to develop a procedural sedation guideline and an audit tool to identify the medications chosen, the incidence of predefined...
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