Sedation of Acute Behaviourally Disturbed Patients

DORM and Post DORM

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Definition of ABD

‘Least restrictive’ approach

‘talk

dow

n’

Verbal

‘hol

d do

wn’

Physical

‘take

dow

n’

Chemical

Security – a helping hand..

• Clear response • Well trained

• Not police • Not vindictive

• ‘Show of force’ • 5-point restraint

Reason for ABD

Alcohol intoxication 70%

Deliberate Self-harm 40%

Drug-induced delirium 8%

Psychosis 5%

Other 3% 0.0

0.1

0.2

0.3

0.4

0.5

Intoxicated Patients

Bre

ath

Alco

hol

Issues with managing ABD patients

• Staff safety • Physical injury • Needle stick injury

• Patient safety • Asphyxia from placing in prone position • Oversedation • Aspiration

A bit of this and a bit of that.. Now what ?!

The dawn of… ‘DORM’

The DORM Project

1. DORM ... the original planned study • RCT • Is droperidol or midazolam “better”?

2. Post-DORM ... Phase IV type study • Safety of droperidol? • Can we implement the findings of the study? • Other third-line agent?

DORM I results

Droperidol 10 mg

Midazolam 10 mg

Droperidol 5 mg & Midazolam 5 mg

Patient no. 33 29 29

Time for sedation

20 min 24 min 25 min

Additional sedation

11 (33%) 18 (62%) 12 (41%)

Adverse events

2 8 2

Isbister G et al. Ann Ermerg Med. 2010;56:392-401.

DORM II Protocol

• Droperidol 10mg imi • Observe, SAT score • IF remains unsedated after 10 to 15min (SAT = +2,+3)

• Droperidol 10mg imi • Observe, SAT score • IF remains unsedated after 10 to 15min (SAT = +2,+3)

• Senior discussion (ED or Tox consultant) • Ketamine, Benzodiazepines, other.

Calver L et al. Ann Emerg Med. 2015.

Recruitment Calvary Mater Newcastle Princes Alexandra Prince of Wales Gold Coast Cairns Prince Charles

Initial Droperidol Dose Median = 10mg (2.5 – 20mg)

QT analysis

• 13/1009 abnormal • 1.3% (95%CI: 0.7-

2.3%) • QT nomogram

controls • 1.3% (95%CI: -0.4%-

3.4%) • Abnormals:

• One pre-existing • Methadone (2) • Escitalopram (2) • Amiodarone (1)

Sedation Cohort

• 1403 given droperidol initially • Time to sedation:

• 19min (IQR: 10 – 30min)

• Successful sedation within 120min

• 1354 (97%)

• Additional sedation • 435 (31%)

Adverse Effects

• No cases of TdP • Total = 203

(14.5%) • Arrhythmia

• Flutter (cardiac hx)

• Desat/Obstuct/ • SAT -3

• Many with benzo additional or prior

Adverse Effect No. % Desaturation (<90%) 21 1.5% Airway Obstruction 9 0.6% Hypotension 29 2.1% Extrapyramidal Side-effects 7 0.5% QT abnormal 13 0.9% Injury/Fall 4 0.3% Arrhythmia 1 0.1% Other 6 0.4% Bradycardia 3 0.2% Oversedation SAT = -3 (AVPU = U) 110 7.8%

Summary: DORM Studies • Change of PRACTICE

• Structured sedation evaluation tool • Sedation Assessment Tool • From titrated IV/combination sedation to single agent

• Results: • Better outcomes for staff • Less inherent risk for patients

Current sedation regime..

10 mg droperidol IM

10 mg droperidol IM / IV

‘Difficult to sedate’ (3%)

Sedated

69%

Sedated

Need more (15 min) ?

✔

✔

Case

• 35 M has a history of methamphetamine use, was brought in by police to a small hospital having been involved in a high speed chase at 200 kph with police. Police called off the chase. His car went into road works and his tyres were punctured. Police broke into his car and brought him into the ED handcuffed and prone in an extreme agitated state.

• You have given him 10 + 10 mg droperidol IMI 20 minutes ago.

• He is still agitated.

What would be your next drug of choice?

•Midazolam 5-10 mg IMI •Diazepam 5-10 mg IVI •Ketamine 4-5 mg/kg IMI •Droperidol 5-10 mg IMI

62 patients Midazolam IV or IM in 10 mg increments up to 4 doses. 31% had an adverse event

– ↓ GCS (≤8) 8 patients – ↓ BP (<90 mm Hg) 7 patients – Hypoxia 4 patients

68 % sedated with one dose 88% with 2 doses, 92% with 3 doses 55% stimulant drug induced toxicity

Spain D et al. EMA 2008;20(2):112-20.

Ketamine

Five patients were not sedated < 120min or required additional sedation within 1h. 4/5 given 200mg or less.

Adverse effects: 3 (6%) 2 vomiting 1 transient desaturation to 90% after ketamine that responded to oxygen.

49 patients administered rescue ketamine Median dose of ketamine was 300mg (50 to 500mg). Median time to sedation post-ketamine = 20min

Ketamine

• Ketamine appeared effective and did not cause obvious harm in this small sample

• Potential option for patients who have failed previous sedation. • A dose of 4-5mg/kg is suggested • Doses <200mg are associated with treatment failure.

Ketamine Vs haloperidol for severe prehospital agitation • Prospective open label study requiring

chemical sedation for severe acute undifferentiated agitation.

• Ketamine (5 mg/kg imi) vs haloperidol (10 mg imi)

• Mean time to sedation: 5 min for ketamine vs 17 min for haloperidol.

• Intubation rate: 39% patients who received ketamine vs 4% in haloperidol group.

Cole JB et al. Clin Tox 2016, April 11.

Ketamine vs haloperidol

Droperidol in other SETTINGs!

• Have not been properly tested. • Pre-hospital • Mental Health Facilities

• Good clinical guidelines must define the setting, patients and evidence.

Conclusion…. Droperidol sedates NOT CURES !

• 97% of ABD patients in ED • Perfect for intoxicated patients or drug induced delirium

• NOT…

• Treatment of dementia • Treatment of psychosis • Treatment of withdrawal syndrome • Treatment of delirium

Conclusion…. Droperidol not able to sedate

• This applies to 3% of the ABD patients in the ED. • Use a second line agent. • Be prepared for complications & resuscitation.

Questions? Acknowledgements: Leonie Calver DORM Investigators

Geoffrey Isbister Michael Downes Colin Page Betty Chan David Spain Francis Kinnear Luke Wheatley

Clinical Toxicology Research Group Renai Kearney

ED Nursing and Medical Staff NSW Health funding

Haloperidol vs Droperidol for aggression in MH

Calver et al. Br J Psychiatry 2015.