Authorship : Dr Minh Le Cong, Dr Andy Buck, Dr George Douros, Dr Casey Parker, Dr Tim Leeuwenberg,

Peer reviewers: Dr Amit Maini, Dr Peter Fritz, Dr Michael Downes

Intended target audience for this guideline:

The occasional sedationist e.g rural health provider, medical resident on ward

Those who encounter acutely agitated patients in low resource settings such as rural clinics/hospitals i.e no formal security team response

Rationale/background to this guideline: The emergency sedation of the acutely agitated patient is a high risk procedure for both the patient as well as the treating providers. Recurrent cases of sedation related misadventures and deaths have motivated the authors of this document to produce this evidence and practice based consensus guideline. We have coined the title “Surviving Sedation Guidelines” as a paraphrase to the well known “Surviving Sepsis” campaign to draw attention to key principles of safe sedation that we believe to be the pillars of quality care and patient safety.

Further background reading relating to Coroner’s cases and emergency sedation:

Lessons for management of acute agitation in rural EDs

David Lees Coroners report

Lyji Vaggs Coroners report

Adam Fernandez Coroners report

KEY PRINCIPLES OF SURVIVING SEDATION GUIDELINES

Early Goal Directed Sedation (EGDS) – titrated sedation to an objective level using a validated sedation scoring system Consideration of emergency sedation as a form of procedural sedation/anaesthesia. Minimum standards of patient assessment , resuscitation equipment and clinical monitoring. De-emphasis on sedative drug choices with more emphasis on continuous clinical assessment and titration to effect

DOWNLOAD GUIDELINES HERE >>SSG2015v6-3

(thanks to Tim Leeuwenburg for updated version 5.0 updated 23rd May 2015!)

Guidelines Objectives:

(1) Provide standardised clinical approach for the safe emergency sedation of a patient who is acutely disturbed

(2) Maintain minimum standards of sedation assessment and monitoring

(3) Enhance patient and clinical team safety

Absolute contraindications to retrieval sedation:

 Known allergies/adverse reactions to sedative agents

Relative contraindications to emergency sedation:

 Recent ingestion of food (last 6 hrs) or clear fluids (last 2 hrs)

 Respiratory tract disease/infection

 Substance abuse/intoxicated state

Disclaimer: This guideline does not replace sound clinical judgment by individual practitioners dealing with specific clinical problems for a given case. It is intended as an educational guide only.

Medicolegal aspects to emergency sedation:

Each state has its own Mental Health Act (MHA) with its own definitions, laws and requirements.

‘Restrictive interventions’ is defined as

‘ bodily restraint’ (encompassing both ‘ physical restraint’ using hands-on immobilization and ‘ mechanical restraint’ using the application of devices. Both require trained staff) and

(encompassing both ‘ using hands-on immobilization and ‘ using the application of devices. Both require trained staff) and ‘seclusion’ (sole confinement of a person to a room or any other enclosed space, from which it is not within the control of the person confined to leave).

Restrictive interventions are not therapeutic and can result in patient morbidity and mortality when performed improperly and should only be used

to prevent imminent and serious harm to the person or to another person and

when all reasonable and less restrictive options have been tried or considered and found to be unsuitable.

All Restrictive interventions have mandatory state-wide monitoring, observation, clinical review, notification and paperwork requirements. Please familarise yourself with your state’s MHA requirements and paperwork. Additional to this, please familiarize yourself with local policy.

Patients who require either restrictive interventions or parenteral sedation are high-risk patients whose care should be escalated to the most trained personnel (eg: CODE GREY activating Behavioural Response team involving Senior ED doctor with airway experience, Nurse in charge, Security and psychiatric services) present so that

an accurate medical and mental state risk assessment can be performed

de-escalation/ oral anxiolysis can be attempted

management formulation taking into account both patient and environmental factors particularly if restrictive measures/ parenteral sedation is required

all the medico-legal requirements are met

Acute/emergency sedation :

General principles of sedation practice:

(1) The sedation provider must have the necessary resuscitation skills and pharmacologic knowledge to rescue a patient from sedation that is causing airway obstruction and /or cardiorespiratory deterioration.

(2) All sedation should be undertaken with a targeted sedation level goal with concomitant reduction in agitation level. A standardized sedation/agitation score should be used to maintain consistent and reliable sedation practice for a targeted effect.

(3) As much as is practically possible, acute sedation should be conducted in a planned and properly timed manner with proper airway and medical assessment, establishment of IV access and monitoring, informed consent and standardized sedation/agitation scoring. The recommended location to initiate sedation is in a hospital/facility setting.

(4) Sedation should never be regarded as the mainstay of risk management for the disturbed patient. Physical security in the form of restraints and trained escorts must be utilized. Sedation allows better tolerance of mechanical restraint.

(5) Planned sedation should be monitored using similar levels of charting, observation and nursing care as accorded for a ventilated anaesthetic patient.

(6) It is culturally appropriate to enquire as to alternative methods of managing acute agitation and trying to accommodate specific cultural aspects of patient care.

(7) Consideration of assistance from family or close friend who is trusted by the patient should be a part of good clinical care particularly if this will assist with communication and language issues.

Acute sedation assessment/planning and monitoring:

(1) Prior to any acute sedation the following assessments are recommended if practical and feasible to perform: Airway assessment: A Mallampati score should be documented. Ideally patient is sitting up and voluntarily opening the mouth to the examiner. Class 3-4 Mallampati should be considered high risk for problems of hypoxia, airway obstruction and difficult airway management during sedation. Problems with bag /mask ventilation can be predicted with one or more of the following patient factors:  Beard  Male  Obesity  Past radiotherapy to airway  Elderly  Suspected or known obstructive sleep apnoea

Medical assessment:  Fasting status  Recent respiratory tract infection  Any allergies should be documented.

SEDATION RISK FACTORS:

Age > 50 – more likely to have more actual or occult co-morbidities (eg occult IHD)

Obese – airway issues and comorbidities

Renal impairment/dialysis – usually have obvious fistula! (due to delayed drug excretion)

Heavy EtOH intoxication – additive sedative effects with drugs and aspiration risk

If 1 or more of above risk factors for safe sedation, then consider alternative non drug strategies to reduce arousal/agitation, use lower sedative doses and seriously consider need for tracheal intubation and general anaesthesia.

(1) The Sedation Assessement Tool is a validated scoring system in the ED setting and is recommended to be used to assess agitation and target a sedation level appropriate for the agitated emergency patient.

score Responsiveness Speech +3 combative, violent, out of control continual loud outbursts +2 very anxious and agitated loud outbursts +1 anxious/restless normal / talkative 0 awake and calm/cooperative normal -1 asleep but rouses if name called slurring or prominent slowing -2 responds to physical stimulation few recognisable words -3 no response to stimulation nil

A SAT score should be documented prior to any sedation administration and a target SAT score should be clearly documented or communicated to other team members as a major goal of the sedation plan. The recommended target SAT score for emergency sedation is between 0 to -1. At times , periods of brief but intense environmental stimuli may necessitate a deeper level of sedation, a SAT score to -2 maybe appropriate. It is considered inappropriate to target a SAT score of -3 at anytime for planned sedation unless the decision to intubate and ventilate has been made. The SAT score should be documented regularly and as frequently as the vital sign observations are recorded. Disclaimer: Whilst the SAT is to be used as a tool to guide sedation targets it does not replace clinical judgment on a case by case basis as to the level of sedation required for a given patient and situation.

(2) Medical monitoring

Acute sedation carries significant risks, and minimum parameters for physiological monitoring and resuscitation equipment are proposed. Continuous electrocardiographic monitoring and pulse oximetry should be used, along with blood pressure recordings. Non-invasive capnography should be available. Oxygen supply, a suction device and basic airway equipment are mandatory items.

POST SURVIVING SEDATION CARE /DISPOSITION

Full medical assessment should be undertaken once the patient is adequately sedated. Simple things should not be missed e.g fever, low blood glucose, neck stiffness

Patient should be positioned 45 deg head up or in lateral recovery position

Minimum sedation monitoring( cardiac monitor, pulse oximetry and BP monitoring) and 1:1 nursing should be maintained until SAT score = 0

If involuntary patient under Mental health act, then disposition plan to transfer to secure ward must be initiated. Ideally oral sedatives should be offered to maintain SAT score 0 to -1 whilst transfer to secure ward organised

If aeromedical retrieval required to transfer to secure ward then refer to Australasian aeromedical consensus statement 2015.

If voluntary patient under Mental health act i.e alcohol intoxicated patient treated under Guardianship act, then need to monitor SAT and behaviour and observe till sober and adequate examination can be undertaken.

A patient who has received sedation should never be discharged into their own care and all efforts should be made to have a responsible adult monitor the patient if discharge is deemed suitable. Otherwise short stay observation admission is warranted until the patient is fully recovered and not displaying ongoing agitated behaviour.

Reference List:

JC Chevrolet, P Jolliet. Clinical review: agitation and delirium in the critically ill –significance and management. Critical Care 2007, 11:214

SP Keenan. Sedation in the ICU. Critical care Rounds 2000, 1 (3); Canadian Critical society.

J Shen. Sedation and Analgesia in the Intensive care unit. Hong Kong Medical Diary 2009, 14(9).

Calver LA1, Stokes B, Isbister GK.Sedation assessment tool to score acute behavioural disturbance in the emergency department.Emerg Med Australas. 2011 Dec;23(6):732-40.

EL Bahn, KR Holt. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin N Am 2003, 23:503-517.

Guidelines on Sedation and/or Analgesia for Diagnostic and Interventional Medical, Dental or Surgical Procedures, ANZCA Professional standard Jul 2014, viewed on 20th August 2014 at http://www.anzca.edu.au/resources/professional-documents/pdfs/ps09-2014-guidelines-on-sedation-andor-analgesia-for-diagnostic-and-interventional-medical-dental-or-surgical-procedures.pdf

SA Godwin, DA Caro, SJ Wolf, AS Jagoda, R Charles, BE Marett, J Moore. Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department. Ann Emerg Med 2005, 45:177-196.

Spain D1, Crilly J, Whyte I, Jenner L, Carr V, Baker A.Safety and effectiveness of high-dose midazolam for severe behavioural disturbance in an emergency department with suspected psychostimulant-affected patients.Emerg Med Australas. 2008 Apr;20(2):112-20.

Leonie A Calver, 1,2 Michael A Downes,1,2,3 Colin B Page,2,4 Jenni L Bryant,1,5 and Geoffrey K Isbister1. The impact of a standardised intramuscular sedation protocol for acute behavioural disturbance in the emergency department.BMC Emerg Med. 2010; 10: 14.

Leonie Calver,1,2 Vincent Drinkwater,3 and Geoffrey K Isbister.A prospective study of high dose sedation for rapid tranquilisation of acute behavioural disturbance in an acute mental health unit.BMC Psychiatry. 2013; 13: 225.

G Isbister et al. Randomized controlled trial of intramuscular droperidol versus midazolam for violence and acute behavioral disturbance: the DORM study. Ann Emerg Med. 2010 Oct;56(4):392-401

E Chan et al. Intravenous Droperidol or Olanzapine as an Adjunct to Midazolam for the Acutely Agitated Patient: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Ann Emerg Med, 2013, 61(1) :72-81

M Wilson et al. The Psychopharmacology of Agitation: Consensus Statement of the American Association for Emergency Psychiatry Project BETA Psychopharmacology Workgroup. WJEM, 2012, 13(1) :26-34

R Berman et al. Antidepressant effects of ketamine in depressed patients. Biol Psych, 2000,47(4): 351- 354

R Price et al. Effects of Intravenous ketamine on Explicit and Implicit Measures of Suicidality in Treatment-Resistant Depression. Biol Psychiatry. Sep 1, 2009; 66(5):522-526.

C Harihar et al. Intramuscular ketamine in acute depression: A report on two cases. IndJPsych, 2013, 55 (2): 186-188

Special Panel Review of Excited Delirium Less-Lethal Devices Technology working Group NIJ Weapons and Protective Systems Technologies Center. https:www.jusnet.org/pdf/ExDS-Panel-ReportFINAL.pdf

M Le Cong, B Gynther, E Hunter, P Schuller. Ketamine sedation for patients with acute agitation and psychiatric illness requiring aeromedical retrieval. Emerg Med J doi:10.1136/emj.2010.107946

C Parsch, W Emmerton. Ketamine use in retrieval of psychiatric patients. MedSTAR, 2012

G Vilke et al. EXCITED DELIRIUM SYNDROME (EXDS): DEFINING BASED ON A REVIEW OF THE LITERATURE. J Emerg Med. 2012 Nov;43(5):897-905

Michael P Wilson, MD, PhD,* David Pepper, MD,† Glenn W Currier, MD, MPH,‡ Garland H Holloman, Jr, MD, PhD,§ and David Feifel, MD, PhD.The Psychopharmacology of Agitation: Consensus Statement of the American Association for Emergency Psychiatry Project BETA Psychopharmacology Workgroup.West J Emerg Med. 2012 Feb; 13(1): 26–34.

Ho et al. Successful management of excited delirium syndrome with prehospital ketamine: two case examples. Prehosp Emerg Care, 2013 Apr-Jun;17(2):274-9

A Pritchard, M Le Cong. Ketamine sedation during air medical retrieval of an agitated patient. 2014, 33(2):76-77

D Keseg. Vitamin K or KO ? Outcomes of EMS Ketamine Use. NAEMSP 2014 ANNUAL MEETING.

M Le Cong, E Finn, C Parsch. Management of the acutely agitated patient in a remote location. Med J Aust 2015; 202 (4): 182-183

Calver L1, Drinkwater V1, Gupta R1, Page CB1, Isbister GK1 .Droperidol v. haloperidol for sedation of aggressive behaviour in acute mental health: randomised controlled trial.Br J Psychiatry. 2015 Mar;206(3):223-8.

Leonie Calver; Colin B. Page, MBChB; Michael A. Downes, MBBS; Betty Chan, MBBS, PhD; Frances Kinnear, MBBS; Luke Wheatley, MBBS; David Spain, MBBS; Geoffrey Kennedy Isbister, MD, BS. The Safety and Effectiveness of Droperidol for Sedation of Acute Behavioral Disturbance in the Emergency Department (DORM II study). Ann Emerg Med. 2015;-:1-9