Procedural sedation practices in Australian Emergency Departments

ORIGINAL RESEARCH

Procedural sedation practices in AustralianEmergency Departmentsemm_1418 458..465

Anthony Bell,1 David McD Taylor,3,4 Anna Holdgate,9,10 Catherine MacBean,5 Truc Huynh,12 OgilvieThom,2 Michael Augello,4,6 Robert Millar,3 Robert Day,11 Aled Williams,13 Peter Ritchie7 and John Pasco8

1Queen Elizabeth II Jubilee Hospital, Brisbane, 2Redcliffe Hospital, Redcliffe, Queensland, 3AustinHospital, Melbourne, 4Department of Medicine, University of Melbourne, Melbourne, 5Royal MelbourneHospital, Melbourne, 6St Vincent’s Hospital, Melbourne, 7Sunshine Hospital, Melbourne, 8MercyHospital (Werribee), Werribee, Victoria, 9Liverpool Hospital, Sydney, 10South West Clinical School,University of NSW, Sydney, 11Royal North Shore Hospital, Sydney, New South Wales, 12Royal AdelaideHospital, Adelaide, South Australia and 13Sir Charles Gairdner Hospital, Nedlands, Western Australia,Australia

Abstract

Objective: The aim of the present study was to describe procedural sedation practices undertaken ina spectrum of Australian EDs.

Methods: Eleven Australian EDs enrolled consecutive adult and paediatric patients between January2006 and December 2008. Patients were included if a sedative drug was administered for anED procedure. Data collection was prospective and used a specifically designed datacollection document.

Results: 2623 patients were enrolled. 1581 were male (60.3%, 95% CI 58.4–62.2) and the meanpatient age was 39.2 (SD 25.2) years. Reductions of fracture/dislocated shoulders (694 cases,26.7%), wrist/forearm fractures (403, 15.5%) and tibia/fibula fractures (341, 13.1%) werethe most common procedures. Procedures were supervised by consultants and registrars in1424 (54.3%) and 1025 (39.1%) cases, respectively. Of 2413 patients with complete fastingstatus data, 1252 (51.9%, 95% CI 49.9–53.9) patients had consumed food or fluid in theprevious 6 h. 1399 (53.3%, 95% CI 51.4–55.3) patients received pre-procedural medication.Pre-procedural morphine (894, 34.1%) exceeded fentanyl use (323, 12.3%), both as a soleagent and in combination with another agent. The principal sedatives used alone werepropofol (857, 38.5%), midazolam (224, 10%) and ketamine (165, 7.4%). Ketamine andnitrous oxide were most commonly used in children with propofol, midazolam and opiateslargely restricted to adults (P < 0.001). The intra-procedural use of adjunct fentanylexceeded that of morphine (ratio 4:1).

Conclusions: Procedural sedation practice across Australian EDs is varies considerably. Proceduralsedation ‘best practice’ guidelines, based upon the findings of the present study and theavailable evidence, are recommended.

Key words: analgesia, emergency department, principal sedative, procedural sedation, procedure type.

Correspondence: A/Prof David Taylor, Emergency Department, Austin Health, Studley Road, Heidelberg, Vic. 3084, Australia. Email:[email protected]

Anthony Bell, FACEM, Director of Emergency Medicine; David McD Taylor, MD, MPH, DRCOG, FACEM, Director of Emergency and GeneralMedicine Research, Principal Fellow; Anna Holdgate, MMed, FACEM, Director of Emergency Medicine Research; Catherine MacBean, BA, DipEd,Research Assistant (formerly); Truc Huynh, FACEM, Staff Specialist; Ogilvie Thom, FACEM, Staff Specialist; Michael Augello, FACEM, StaffSpecialist, Honorary Fellow; Robert Millar, FACEM, Staff Specialist; Robert Day, FACEM, Staff Specialist; Aled Williams, FACEM, StaffSpecialist; Peter Ritchie, FACEM, Director of Emergency Medicine; John Pasco, FACEM, Director of Emergency Medicine.

doi: 10.1111/j.1742-6723.2011.01418.xEmergency Medicine Australasia (2011) 23, 458–465

© 2011 The AuthorsEMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine

Introduction

Procedural sedation and analgesia (PSA) is nowaccepted practice within the ED. The current researchliterature describes the development of the agents usedand establishes the scientific basis for safety and effi-cacy in the ED setting. The phases of PSA developmenthave offered new perspectives as new pharmacopoeiaand improved monitoring have become available.1

Shorter acting agents from the opiate and benzodiaz-epine classes, along with their reversal agents, wereonce considered standard practice.2 Subsequently,newer ultra short acting agents (e.g. propofol3–6) havefound their way into ED formularies and there isrenewed interest in some older agents (e.g. ketamine7,8).Hence, ED PSA practice has evolved over time and ananecdotal variation in practice seen between emergencyphysicians (EPs) has resulted.

In Australia, the existing PSA guidelines are formu-lated in general terms by collaboration between theAustralian and New Zealand College of Anaesthetistsand the Australasian College of Emergency Medicine.9

However, specific implementation of these guidelinesare left to institutions.2 Emergency medicine as a spe-cialty has embraced the need for up-skilling and train-ing in PSA to ensure maintenance of core skills. EPs andtrainee registrars (ERs) need to acquire the requiredskill set through exposure to and training in decisionmaking, anaesthetic techniques, airway and resuscita-tion management, orthopoedic and other procedures.Innovative research and critical appraisal of the litera-ture by Australian EPs provide a local context forPSA.10–22

Credentialing processes and competency-based ass-essments are becoming more widespread23,24 and someAustralian states have linked incentive funding to theestablishment of PSA credentialing. Such processeseducate staff about patient risk assessment, monitoringrequirements, potential complications and the skill mixrequired for delivering PSA. However, they fall short inmaking firm recommendations about drug selectionand dosing. Fasting status, in particular, is importantfor pre-procedural risk assessment and a tool is avai-lable that describes a prudent approach to the issue ofrecent oral intake.25 The theoretical components of suchprograms are largely consistent with internationalconsensus.26,27

The present study aimed to determine the nature ofcontemporary procedural sedation practice in Austra-lian EDs. The results, in conjunction with other compo-

nents of the project including adverse events28 andfailed procedures,29 will inform the development ofAustralian PSA guidelines.

Methods

The present study was part of a multi-centre, prospec-tive, observational project undertaken at 11 AustralianEDs between January 2006 and December 2008. Thecollaboration included the Royal Brisbane and Women’s(QLD), Liverpool (NSW), Royal Adelaide (SA), Box Hill(QLD), St Vincent’s (VIC), Austin (VIC), Royal NorthShore (NSW), Sir Charles Gairdner (WA), Royal Mel-bourne (VIC), Geelong (VIC) and Alfred (VIC) HospitalEDs. Six were mixed (adult/paediatric) and five wereadults-only EDs. The annual patient censuses rangedfrom 36 000 to 69 000. The study was authorized by theHuman Research Ethics Committee of each participat-ing institution.

Consecutive patients (adult or paediatric) whorequired the administration of a sedative drug to facili-tate a procedure were enrolled. There were no exclusioncriteria. As the study was purely observational, with nochange in usual practice, informed patient consent wasnot required.

Most data were collected at the time of the pro-cedure by clinical staff attending the patient. Thesedata comprised patient weight, fasting status, level ofsedation, defined incident unexpected events (resp-iratory obstruction/depression/oxygen desaturation,hypo/hypertension, brady/tachycardia, vomiting andpulmonary aspiration), any other events, management ofunexpected events, designation of sedative administra-tor (consultant or registrar) and outcome of the procedure(success or failure).

The Observer’s Assessment of Alertness/SedationScale (OAAS)30 was used to assess the patient’s level ofsedation. This ordinal scale comprises variables of‘responded readily to name spoken in normal tone’,‘lethargic response to name spoken in normal tone’,‘responded only after name was called loudly and repeat-edly’, ‘responded only after mild prodding or shaking’,‘did not respond to mild prodding or shaking’ and ‘didnot respond to noxious (painful) stimulus’. These vari-ables were scored 1–6, respectively. The scale was easyto use and has proven validity and reliability.

Each site investigator collected the remaining data byexplicit medical record review. These data comprisedpatient demographics, the type of procedure, and thenature, time and doses of pre-medication (analgesics or

ED procedural sedation practice

459© 2011 The AuthorsEMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine

anti-emetics) and sedative agents administered. Allstudy data were recorded on a hard copy data collectiondocument specifically designed for the study. It wastrialled and revised before use.

The primary end point in this part of the project wasprocedural sedation practice as a function of the proce-dure undertaken and patient age group (0–16, 17–64,�65 years). This comprised the drugs administered foranalgesia, pre-medication and the sedation itself, andthe designation of the supervising doctor.

Periodically, copies of completed hard copy data col-lection documents were forwarded to the principalstudy site where the data were uploaded into an Excel®dataset by two investigators (CMcB, DT). One siteentered its own data and forwarded their dataset to theprincipal site. At the completion of data entry, an auditof a random selection of 10% of case entries was under-taken to evaluate the accuracy of data transfer into theelectronic dataset. This was followed by range checkswith cross-checking against hard copy data when errorswere identified.

Sample size was based on the incidence of vomiting,an important adverse event examined specifically inanother part of the project. It has been reported thatvomiting occurs in 2% of patients receiving propofol inthe ED.12 If the incidence following another drug is5% in adults, then 620 patients would be required ineach group (significance 0.05, power 0.8). Therefore, acomparison across four sedation groups (propofol,midazolam, ketamine, N2O) will require at least2480 patients (4 ¥ 620). In this part of the project, datawere analysed descriptively with 95% confidence inter-vals (95% CI) fitted around point estimates. SPSS for

Windows statistical software (version 18.0, SPSS,Chicago, IL, USA) was used for data analysis.

Results

Of 2623 patients enrolled, 1581 (60.3%, 95% CI 58.4–62.2) were male and the mean (SD) age was 39.2 (25.2)years. Of 2413 patients with complete fasting statusdata, 1252 (51.9%, 95% CI 49.9–53.9) had consumedfood or fluid in the previous 6 h.

Procedure types, by age group, are described inTable 1. Overall, orthopoedic procedures predominated.Reductions of fractured/dislocated shoulders, wrists/forearms and tibia/fibulae were the most common pro-cedures. Within the group of procedures involving skinor mucosal surfaces (i.e. other ED procedures) childrenaged �8 years most often had laceration repairs andolder patients had incision and drainage of abscesses.More than one-fifth of all procedures for patients�65 years involved procedural sedation for prosthetichip relocation.

The most senior clinician supervising the PSAoverall was an EP in 1427 (54.4%, range 29.3–87.9%)cases and an ER in 1025 (39.1%, range 19–67.7%) cases.These range values refer to the observed rates in differ-ent EDs. At two sites, Nurse Practitioners supervised upto 5.6% of procedures.

A total of 1399 (53.3%, 95% CI 51.4–55.3) patientswere administered pre-procedural medication (Table 2).Pre-procedural morphine exceeded fentanyl use, both asa sole agent and in combination with another agent.Oral analgesia was occasionally used alone.

Table 1. Procedure type by age group

Procedure category 0–16 years 17–64 years �65 years Totaln (%) n (%) n (%) n (%)

Shoulder reduction 32 (1.3) 510 (19.6) 152 (5.8) 694 (26.7)Wrist/forearm reduction 49 (1.9) 256 (9.8) 98 (3.8) 403 (15.5)Ankle, tibia/fibula reduction 28 (1.1) 263 (10.1) 50 (1.9) 341 (13.1)Hip dislocation reduction 1 (0.0) 52 (2.0) 116 (4.5) 169 (6.5)Elbow reduction 24 (0.9) 116 (4.5) 9 (0.4) 149 (5.7)Cardioversion 0 (0.0) 75 (2.9) 41 (1.6) 116 (4.5)Diagnostic LP or CT 16 (0.6) 31 (1.2) 13 (0.5) 60 (2.3)Other procedure† 293 (11.3) 135 (5.2) 23 (0.9) 451 (17.3)Other orthopaedic‡ 39 (1.6) 118 (4.5) 20 (0.8) 177 (6.8)Procedure not recorded 12 (0.5) 26 (1.0) 6 (0.2) 44 (1.7)Totals 408 (18.3) 1343 (60.3) 475 (21.4) 2226 (100)

†I&D, ICC, FB removal and laceration repair. ‡Digit, humerus, femur, patella, mandible reductions. Ages available for 2604 of total2620 patients. LP, lumbar puncture.

A Bell et al.

460 © 2011 The AuthorsEMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine

Tables 3–5 describe the intra-procedural drugsadministered according to procedure type for the threeage groups. Complete data on age, procedure andmedication data were available for 2226 patients. Theprincipal sedatives used alone were propofol, mida-zolam and ketamine.

Overall propofol, alone or in combination, was used inapproximately two-thirds of all cases with adult useaccounting for 94.4% of these. The difference in propor-tion with childhood propofol usage was 88.8% (95% CI87.1–90.5). Propofol was combined with an IV opiatemore frequently than with either ketamine or mida-zolam. Similarly, midazolam was frequently combinedwith either an IV opiate or ketamine.

Approximately, two-thirds (65.7%) of ketamine use,alone or in combination, was in children. The differencein proportion with adult ketamine use was 31.3% (95%CI 23.3–39.4) Nitrous oxide use was used considerablyless than other agents. The IV fentanyl: morphine use

ratio, when administered intra-procedure, was 4.2:1(674 : 162) taking account of all 2623 patients.

As there was no direct way of determining the overallenrolment rate of all potential patients, a snapshot ofpatients with dislocated shoulders presenting to fivelarge participating sites was undertaken during theweek of February 19–25, 2007. During this period,85.7% of patients meeting the entrance criteria wereenrolled.

Discussion

This is the largest multi-centre observational study ofED PSA practice in Australia to date. Accordingly, theresults will inform procedural sedation practice whencombined with the adverse event28 and failed proceduredata.29

A large number of procedures, both therapeutic anddiagnostic, are commonly performed using proceduralsedation with or without analgesia. In this Australiansetting, morphine is the preferred pre-procedural opiateand intra-procedural fentanyl has become popular. Theshorter acting opiate fentanyl has the advantages ofease of titration, more rapid onset of action and betterhaemodynamic stability over morphine.2 Despite this,nearly half of patients did not have any pre-proceduralanalgesia. This is consistent with reports that oligoan-algesia is an issue to be addressed.31,32 However, thereare possible explanations. Analgesia might have beenrefused by the patient, not required until the procedurewas under way, or might have been administered butnot recorded on study documentation.

Australian procedural sedation practice varies con-siderably. Many different combinations of agentsare used. Sedative drugs are used either alone or incombination with analgesia. Some agents (ketamine andnitrous oxide) possess both analgesic and sedative prop-erties. The use of the second and third generation agents,fentanyl and propofol in particular in adults and thecommon use of ketamine in children is noteworthy. Mor-phine and midazolam as a combination appears to havelost favour. It is notable that existing ANZCA proceduralsedation guidelines9 lack useful detail regarding the useof specific sedative drugs of combinations.

A detailed analysis of fasting status, procedural typeand urgency, and depth of sedation is reported else-where.28 However, some generalizations regarding theseconsiderations can be made. Children, most commonlywere not fasted, received a dissociative agent and under-went laceration repair or upper limb fracture manip-

Table 2. Pre-procedural medication administered

Pre-procedural medication types n (%)

None 1225 (46.7)Morphine

Alone 808 894 (34.1)With supplementary analgesia† 74With anxiolytic‡ 12

FentanylAlone 302 323 (12.3)With supplementary analgesia† 3With anxiolytic‡ 18

Oral analgesicsOpioid§ 60 98 (3.7)Simple¶ 38

Inhaled analgesicsAlone 9 9 (0.3)

PethidineAlone 4 4 (0.2)

OtherAnxiolytics alone‡ 24 70 (2.7)Anti-emetics 11Cardiac 22Topical 8Antipsychotics 4Bronchodilator 1

Total 2623 (100)

†Supplementary analgesic can include any simple analgesic, oralopioid or volatile agent. ‡Anxiolytic usually denotes midazolam andrarely denotes diazepam or clonazepam. §Opioid denotes codeinecontaining tablet, oxycodone or tramadol. ¶Simple analgesiadenotes paracetamol, ibuprofen or other NSAID.



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A Bell et al.


ulation. Patients aged �65 years were more likely tobe fasted, receive propofol � fentanyl and have ajoint relocation or forearm fracture reduction. Takingaccount of the realities of ED practice, Green provides auseful framework in consideration of a patient’s riskassessment, fasting time, sedation characteristics andprocedural timing.25 The majority of patients in thepresent study were not fasted for longer than 6 h indi-cating an interplay of time dynamics, patient flow con-siderations and a degree of acceptance among EPs thatprocedural sedation can proceed for the types of proce-dures commonly performed in the ED setting.

The present study has important limitations. Somepatients were not enrolled and the sample was not trulyconsecutive. It was not possible, retrospectively, to deter-mine the number and nature of the patients not enrolledand selection bias might have been introduced. Thestudy only included patients who actually received pro-cedural sedation. No information on patients who werescreened and found not to be suitable for sedation in theED was collected. The study was performed in urbanmixed EDs and might not be representative of paediatricEDs. There is a relative selection bias in that two largeEDs contributed approximately 50% of cases. Nitrousoxide use might not have generated the documentationfor inclusion in the study and might be under repre-sented. There was variation in incremental versus cumu-lative drug dose recording that precluded meaningfulweight-based dosing data. A minor degree of incompletedata might have reduced the precision of some statisticsbut not the overall clinical message derived from it.

It is recommended that future research focuses onqualitative aspects of the procedural sedation experiencefor patients, especially in regard to analgesia administra-tion, pain assessment and recollection of pain. What thepresent study has highlights is that ketamine might beunder utilized in adults, and propofol in children in amixed ED environment. More research into the use ofketamine in adults and propofol in children is recom-mended. Although ketamine-induced emergence typephenomena remain a concern, its prevalence and severityis not known in contemporary ED practice.

Conclusion

Australian Emergency Medicine procedural sedationpractice varies considerably. Procedural sedation guide-lines should now be developed to align practice with theresearch evidence gained in this and previous studies.Consistency of PSA practice with a particular focus onT

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the pre-procedural analgesic requirements of patientswould follow.

Acknowledgements

The authors would like to thank all ED staff, Dr JaimiGreenslade for statistical advice, Dr Lisa New for data-base and data assistance and Professor Peter Cameronfor data collection at the Alfred Hospital.

Competing interests

DMcDT and AH are Section Editors, Original Researchfor Emergency Medicine Australasia.

Accepted 17 March 2011

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Procedural sedation practices in Australian Emergency Departments