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ASSESSING PAIN, SEDATION AND DELIRIUM: PRAGMATICS, PHARMACOKINETICS AND
CONFOUNDERS November 19 2013
19 november 2013
** All lines are muted upon entry. If you have any questions, please raise your hand or CHAT to Host **
Your Hosts & Presenters Vos hôtes & et présentateurs
Dr. Denny Laporta, Chair Canadian ICU Collaborative Président, Collaboration canadienne des soins intensifs Bruce Harries, Collaborative Director Directeur de la Collaboration
Dr. Yoanna Skrobik, Intensivist, Hôpital Maisonneuve Rosemont, Montréal
Paule Bernier, SIA for Quebec Campaign (SHN) Conseillère en amélioration et sécurité, SSPSM (Québec) Ardis Eliason, Project Coordinator and Technical Host for today’s session Coordonatrice de projet et hôte technique Leanne Couves, Improvement Advisor and Moderator Conseillère en amélioration et Animateur
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Faculty Membres de la faculté
Denny Laporta, MC, FRCPC
Claudio Martin, MD, FRCPC
Yoanna Skrobik, MD, FRCPC
Paule Bernier, Dt.P., M.Sc.
John Muscedere, MD, FRCPC
Cathy Mawdsley, RN, M.Sc.
Anne MacLaurin, Project Manager, Canadian Patient Safety Institute (CPSI) /Coordonatrice de projets, ICSP
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POINTER
11/19/2013
What professions are represented? Quelles professions sont représentées?
Nurse/ infirmière
MD
Educator /Éducateur Quality Improvement Professional/Professionnel en amélioarion de la qualité
Infection Control\PCI
Administrator /Administrateur Senior Leader
Other/ autre
POINTER
Psychiatry/ psychiatrie
Pharmacy/ pharmacie
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Objectives But de l’appel
Understand when delirium can and cannot be assessed, and how sedatives make an accurate assessment more complicated
Understand why different genetics, administering more than one drug or duration of sedative drug administration can change therapeutic effect and why it matters in the critically ill
Comprendre quand délirium peut et ne peut pas être évalué, et comment les sédatifs compliquent cette évaluation
Comprendre pourquoi la génétique, la co-administration de plusieurs médicaments ou la durée de l'administration des sédatifs changent leur effet thérapeutique ; les aspects pertinents aux soins intensifs sont évalués
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Dr. Yoanna Skrobik
Assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders
Assessing pain, sedation and delirium: pragmatics,
pharmacokinetics and confounders
Yoanna Skrobik MD FRCP(c)
Yoanna Skrobik MD FRCP(c)
And do we really care?
Conflicts of interest
Member, SCCM Pain, Agitation and Delirium guidelines writing committee
Investigator initiated research funding, Hospira Academic chair, Université de Montréal
Academic chair
Astellas Merck Pfizer Baxter
Hospira Otsuka Novartis
Lilly
assessing pain, sedation and delirium: pragmatics, pharmacokinetics and confounders
Introduction Pain scales and their importance The scales we use for sedation The scales we use for delirium Pharmacokinetics and their role in the continuum The confounders conclusion
assessing pain, sedation and delirium: pragmatics, pharmacokinetics and
confounders
Introduction: why you should care
why we should care (introduction)
• Pain, Sedation and delirium monitoring are mandated on critical care wards for Canadian hospital accreditation • Sedatives and opiates are administered to many patients and more medications
are administered in ICU than on most hospital wards • Excessive sedation is common, and is related to drug kinetics or interaction • This makes delirium screening challenging
Clinical Practice Guidelines for the Management of Pain, Agitation, and
Delirium in Adult Patients in the Intensive Care Unit
Authors: Juliana Barr, MD, FCCM; Gilles L. Fraser, PharmD, FCCM; Kathleen Puntillo, RN, DNSc, FAAN; E. Wesley Ely, MD, MPH, FACP, FCCM; Céline Gélinas, RN, PhD; Joseph F. Dasta, MSc; Judy E. Davidson, DNP, RN; John W. Devlin, PharmD, FCCM; John P. Kress, MD; Aaron M. Joffe, DO; Douglas B. Coursin, MD; Daniel L. Herr, MD, MS, FCCM; Avery Tung, MD; Bryce RH Robinson, MD, FACS; Dorrie K. Fontaine, PhD, RN, FAAN; Michael A.
Ramsay, MD; Richard R. Riker, MD, FCCM; Curtis N. Sessler, MD, FCCP, FCCM; Brenda Pun, RN, MSN, ACNP; Yoanna Skrobik, MD, FRCP; Roman Jaeschke, MD, MSc
ICU PAD Care Bundle
pain
Patient-directed pain control.
pain
Adult ICU patients, both medical and surgical, routinely experience pain, both at rest and with routine ICU care .
Pain in adult cardiac surgery patients, especially women, (i.e., incisional pain due to coughing, respiratory care procedures, and mobilization) remains prevalent and poorly treated .
Procedural pain is common in adult ICU patients .
patient evaluation standards
patient evaluation standards
patient evaluation standards
sedation
Monitoring sedation
The RASS and SAS scales are valid and reliable for measuring quality and depth of sedation in adult ICU patients .
Sedation-Agitation Scale (SAS)
Riker RR, et al. Crit Care Med. 1999;27:1325-1329. Brandl K, et al. Pharmacotherapy. 2001;21:431-436.
Score State Behaviors
7 Dangerous Agitation Pulling at ET tube, climbing over bedrail, striking at staff, thrashing side-to-side
6 Very Agitated Does not calm despite frequent verbal reminding, requires physical restraints
5 Agitated Anxious or mildly agitated, attempting to sit up, calms down to verbal instructions
4 Calm and Cooperative Calm, awakens easily, follows commands
3 Sedated Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off
2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands
1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands
Richmond Agitation Sedation Scale (RASS)
Score State
+ 4 Combative
+ 3 Very agitated
+ 2 Agitated
+ 1 Restless
0 Alert and calm -1 Drowsy eye contact > 10 sec
-2 Light sedation eye contact < 10 sec
-3 Moderate sedation no eye contact
-4 Deep sedation physical stimulation
-5 Unarousable no response even with physical
Ely EW, et al. JAMA. 2003;289:2983-2991. Sessler CN, et al. Am J Respir Crit Care Med. 2002;166(10):1338-1344.
Verbal Stimulus
Physical Stimulus
Sedation confounders
And now for a little pharmacology
Cytochrome P450
Some examples
CYP 450 3A4/5: midazolam, fentanyl
CYP 450 2D6:
haloperidol, codeine, oxycodone, and tramadol
CYP 2C19: propofol
Pharmacokinetics, dynamics and genetics
Is it relevant to ICU patients?
Drug-drug interactions
Daniel Ovakim January 19, 2012
The Effect of Critical Illness on the Pharmacokinetics and Dose-Response
Relationship of Midazolam
Results
Table 1: Patient Characteristics and Study Details Variable Patients enrolled – no. 9 Age – mean +/- SD (range) 56.3 +/- 11 (33-72) Male sex – no. (%) 7 (78) Co-morbidities on admission – no.
CHF 1 CKD 1 Hemodialysis 1 Chronic benzodiazepine use 0 Chronic ethanol use 2 Hepatic dysfunction 2
Condition on study enrollment APACHE II – mean +/- SD (range) 24 +/- 10 (7-43) Acute kidney injury – no. 4 GCS – mean +/- SD (range) 7 +/- 2 (3-14) GCS < 8 – no. (%) 6 (67%)
Study details – mean +/- SD (range) Days in study 8.8 +/- 3.9 (3-14) Days on MDZ infusion 4.8 +/- 3.1 (1-11) Days in study off infusion 4.0 +/- 2.9 (0 -10) Days with GCS < 8 3.8 +/- 4.0 (0-12) GCS < 8 during study – no. (%) 7/9 (78)
Patient Characteristics
Results
Midazolam PK
Table 3: Pharmacokinetic Parameters in Study Participants and Healthy Controls
PK Parameter Study Patients Healthy Controls╪
Mean +/- SD Range Mean +/- SD Range CLss (mL/min) 418 +/- 324 31-1157 376 267-485
T½ (h) 16.0 +/- 9.6 2.3-34.9 3.2 1.0-4.0
Results
Midazolam Clearance
0
200
400
600
800
1000
1200
1400
0 1 2 3 4 5 6 7 8 9
Cle
aran
ce a
t Ste
ady-
Stat
e (C
ss, m
g/m
in)
Patient ID
Clearance at Steady State
Figure 1: Observed intra- and intersubject variability in midazolam clearance at steady-state.
Pharmacodynamic Midazolam characteristics : It’s About Time
• Highly lipid soluble • α-OH midazolam metabolite • CYP3A4 activity decreased in critical illness • Substantial CYP3A4 variability
Pharmacodynamic Midazolam characteristics : It’s About Time
Carrasco G, et al. Chest. 1993;103:557-564.
0
10
20
30
40
50
60
< 1 1-7 > 7
Extubation Alertness Recovery
Sedation Time (days)
Time to Endpoint (h)
Pharmacodynamic Midazolam characteristics : It’s About Time
Bauer TM, et al. Lancet. 1995;346:145-147.
Why people develop coma
100 patients
results
coma Occurrence of coma not related to administered
midazolam or fentanyl doses Coma occurrence correlated with the co-
administration of CYP3A4/5 inhibitors (p=0.0046) when adjusted for doses of fentanyl and midazolam
Coma and plasma levels of fentanyl
Coma and plasma levels of fentanyl
Coma and plasma levels of midazolam
Coma and the effect of CYP3A4/5 inhibitor co-administration
Bottom line
• Validated scales include SAS, RASS and probably MASS • Ramsay and Glasgow not valid • These scales should drive lowering sedation over time or
discontinuing it for longer periods • The longer you are on sedatives and the more combined
drugs you receive the more likely you are to be ‘deep’
delirium
Van der Mast. PhD Thesis, Delirium After Cardiac Surgery, Erasmus University, Rotterdam, 1994
CAM-ICU (Confusion Assessment Method-ICU)
Delirium scales
ICDSC (Intensive Care Delirium Screening
Checklist)
http://www.icudelirium.co.uk/ www.icudelirium.org
Delirium diagnosis in the ICU: how hard can it be?
ICU Delirium diagnostic challenges
Standardized delirium screening in the ICU setting, and
their inherent methodological flaw Potential confounders
DSM IV criteria
American Psychiatric Association, Diagnostic and Statistical Manual IV, American Psychiatric Press, Inc, Washington, DC, 1994
Confounders:
Other psychiatric diagnoses
Other psychiatric diagnoses
Delirium (10-80%) Depression (35-45%) Post-Traumatic stress disorder (35%)
Delirium incidence From 10% to > 85% Intensive Care Med 27:1892-1900
JAMA 286:2703-2710
Crit Care Med 29:1370-1379
JAMA 291:1753-1762
Crit Care 5:265-270
Gen Hosp Psychiatry 17:371-379
Crit Care Med 32:2254-2259
J Am Geriatr Soc 51:591-598
Lancet 2010 Nov 27;376(9755):1829-37
…………..(10% of 6572 patients screened!)
wakefulness
DSM IV criteria
American Psychiatric Association, Diagnostic and Statistical Manual IV, American Psychiatric Press, Inc, Washington, DC, 1994
The data when delirium is considered in the light of sedation level
CAM-ICU and RASS comparison: 69% of CAM-ICU positive assessments occurred in patients with a RASS ≤ 0
Over half of the patients with a RASS of -2 and 25% of those with a RASS -1 were considered not assessable
Among patients whose RASS scored changed more than two levels from the previous day, delirium with the CAM-ICU was five times more likely …..
Numerous studies support the sedation level-positive delirium screening relationship
Prevalence of delirium is a function of wakefulness
Prevalence CAM-ICU positive (%)
Sedated Wakeful Absolute Difference
Riker 45-75 12 30 Ely 83 40 43 Haenggi 53 31 22 Poston 73 49 24 Gusmao-Flores 89 32 57 Patel ? ? 30
IF this is related to sedation, patients should transition from CAM positive to CAM negative when sedation is lightened
Riker. CCM 2012; 40:1092 Posten. AJRCCM 2010:A6701 Ely. JAMA 2001; 286:2703 Gusmao-Flores ICM 2013; epub Haenggi. ICM 2013; epub Patel. AJRCCM 2013; 187:A5237
So what
Delirium is bad for you
Delirium and outcomes
Delirium is strongly associated with increased mortality and LOS in adult ICU patients.
Delirium is moderately associated with the development of post-ICU cognitive impairment in adult ICU patients.
Coma is bad for you
Probably not six of one…
of 102 ICU patients, coma or a positive CAM-ICU result were 10 times more likely to occur prior to sedation interruption .
Patients with “delirium” that cleared as sedation was lightened (termed “drug-related delirium”) had outcomes virtually identical and better than patients who never had delirium
This dramatic difference was consistent for ventilator-, ICU-, and hospital-free days and for one year mortality,
Sedation-related delirium and time on the ventilator, in the ICU and in the hospital
What now?
icdsc
重症监护谵妄筛查表(第一版) 武汉市同济医院
4/8 or more corresponds to a delirium diagnosis
PATIENT EVALUATION DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 Altered level of consciousness* (A-E) If A or B do not complete patient evaluation for the period Inattention Disorientation Hallucination - delusion – psychosis Psychomotor agitation or retardation Inappropriate speech or mood Sleep/wake cycle disturbance Symptom fluctuation TOTAL SCORE (0-8)
Intensive Care Delirium Screening Checklist (ICDSC)
Bergeron, N. Dubois M.J. Skrobik, Y. Intensive Care Delirium Checklist : evaluation of a new screening tool. Intensive Care Medicine, 2001
icdsc
Of ICDSC’s 8 features “psychomotor slowing” should not be considered if this slowing is attributable to sedative administration
consciousness is recognized to be the least valid ICDSC component, particularly when the ICDSC is performed by nurses.
CAM ICU
The validity of the level of consciousness component has not been tested with the CAM-ICU to date.
Should probably stratify positive score by RASS (-1,0 or 1 vs. -2 or less)
Summary of confounders
Psychiatric diagnoses Sedation level Operationally it boils down to judgement :-)
In conclusion
Pain assessment is the first priority Sedation should be validated with a reproducible scale Deep sedation is a lot more likely the longer you have been on
sedatives and the more simultaneously metabolized drugs you are on (especially if doses, even prn, are not titrated down)
Delirium assessment should be documented with simultaneous sedation score levels to ensure the data analysis can account for the sedation confounders subsequently
Other psychiatric diagnoses and their role remain unexplored
Thank you
QUESTIONS?
RAISE YOUR HAND / LEVEZ LA MAIN
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CHAT TO “ALL PARTICIPANTS”
“Taking the Pulse” Poll Sondage « prendre le pouls »
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Canadian ICU Collaborative Faculty
Paule Bernier, P.Dt., Msc, Sir MB David Jewish General Hospital (McGill University), Montreal Paul Boiteau MD, Department Head, Critical Care Medicine, Alberta Health Services; Professor of Medicine, University of
Calgary Leanne Couves, Improvement Advisor, Improvement Associates Ltd. Bruce Harries, Collaborative Director, Improvement Associates Ltd. Denny Laporta MD, Intensivist, Department of Adult Critical Care, Jewish General Hospital; Faculty of Medicine, McGill
University Anne MacLaurin, Project Manager, Canadian Patient Safety Institute (CPSI) /Coordonatrice de projets, ICSP Claudio Martin MD, Intensivist, London Health Sciences Centre, Critical Care Trauma Centre; Professor of Medicine and
Physiology, University of Western Ontario; Chair/Chief of Critical Care Western Cathy Mawdsley, RN, MScN, CNCC; Clinical Nurse Specialist – Critical Care, London Health Sciences Centre; John Muscedere MD, Assistant Professor of Medicine, Queens University; Intensivist, Kingston General Hospital 87 11/19/2013
Reminders Rappels
Call is recorded Slides and links to
recordings will be available on Safer Healthcare Now! Communities of Practice
Additional resources are available on the SHN Website and Communities of Practice
L'appel est enregistré Les diapositives et liens
vers les enregistrements seront disponibles sur Des soins de santé plus sécuritaires maintenant! Communautés de pratique
Des ressources supplémentaires sont disponibles sur le site Web SSPSM et Communautés de Pratique
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THANK YOU MERCI
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