SEDATION FOR SMALL PROCEDURES
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1 SEDATION FOR SMALL PROCEDURES Sinno Simons Erasmus MC Sophia Children s Hospital Rotterdam, the Netherlands s.simons@erasmusmc.nl
2 SEDATION in newborns How and when How to evaluate How to dose
3 Why to use sedation?
4 Taddio et al. Lancet 1995 Long term effects of pain
5 Why use sedation: Pain or distress? Both need to be prevented and treated Discussion about short and long term effects of pain and distress is more important
6 Stress Analgesia Sedation Pain Inflammation Stressfull procedures Oxidative stress
7 What do we know? Neonatal distress / pain: Decrease in white and grey matter Brummelte, 2012 Epigenetic changes (SLC6A4) Provenzi, 2015 Worse cognitive and motor development Grunau, 2009 Less visual/perceptive skills Doesburg, 2013 Thinner cortex and decrease in cerebellar volume Ranger, 2013 & 2015 Changed reaction to stress Grunau, 2013 More internalising behavior Ranger, 2014
8 Neonatal pain/distress experience does have negative long term effects But what about the negative effects of sedative and analgesic drugs?
9 How to use sedation? Examples: Intubation INtubation SUrfactant Extubation (INSURE) Mininally Invasive Surfactant Therapy (MIST)
10 Premedication for Endotracheal Intubation in (premature) Neonates
11 POLAND: no consensus about medication Survey all 30 tertiary NICUs 10% always use premedication, 40% use premedication before intubation only sometimes, in case of technical difficulties of active term newborns. 15,5% never use any sedation or analgesia before intubation. Used drugs: - midazolam (11 units, 35%), - analgesics (10 units, 33,3%) (morphine, fentanyl, or pethidine) - phenobarbitone (4 units, 13,3%), - muslce relaxants (6,6%) Premedication for endotracheal intubation in NICU in Poland. E. Adamska, Pediatria polska 82(12): January 2007
12 Endotracheal intubation: evidence Neonatal elective intubation more successful if pre-treated Evidence for morphine, atropine and suxamethonium vs placebo (Oei et al 2002) Untreated intubation probably harmful for the newborn infant Premedication prevents acute physiological changes (VanLooy et al 2008) Endotracheal intubation seriously painful intervention (Simons et al 2003) No consensus about treatment regimen Wide variability in treatment protocols among centres (Kumar et al 2008 / Simon et al 2004)
13 Use of premedication increases; no consensus about medication Country Year Routine medication Protocol Reference UK % 14 % UK %? Australia %? France %? Ireland % Italy %? USA % 24 % France % 60 % UK % 76 % UK % 82 % Whyte et al. 2000, Arch Dis Child Fetal Neonatal Ed. Hancock et al. 2000, Arch Dis Child Fetal Neonatal Ed. Hanock et al. 2000, Arch Dis Child Fetal Neonatal Ed. Simon et al. 2004, Crit Care Med. O Gorman et al. 2005, Ir Med J Lago et al. 2005, Paediatr Anesth Sarkar et al. 2005, J of Perinatology Walter-Nicolet et al. 2007, Archives de Pediatrie Chaudary et al. 2009, Pediatric Anesth Kelleher et al. 2009, Arch Dis Child Fetal Neonatal Ed.
14 What do we need? Adequate ways to measure the level of sedation Adequate drugs and dosages
15 How to evaluate sedation Intubation Readiness Score Score Motor reaction to stimulus 1 Spontaneous movement 2 Movement in reaction to slight touch 3 Movement in reaction to firm stimulus 4 No movement EVALUATION OF AN INTUBATION READINESS SCORE TO ASSESS NEONATAL SEDATION BEFORE INTUBATION Ellen de Kort et al. Neonatology in press
16 How to evaluate sedation
17 Adequate drugs? Opioids Morphine Remifentanil Fentanyl Sufentanil Muscle relaxants / neuromuscular blockers Rocuronium Succinylcholine (Cis)atracurium +/- Atropine Hypnotic / sedative drugs Propofol Midazolam Phenobarbital Ketamine Clonidine Thiopental
18 INSURE
19 Adequate drugs? Short onset of action: (semi) urgent intubation Fast recovery: INSURE to enable extubation Persistent breathing of newborn : MIST... without any negative effects on the developing newborn!
20 Traditional drugs Opioid + muscle relaxant (+ atropine) Morphine + vecuronium Gold-standard therapy Extensive experience Unwarranted Pk/Pd properties (relatively long T max and T 1/2 ) Fentanyl + rocuronium / succinylcholine Sedation? Preferable Pk/Pd properties (relatively long Tmax and T1/2 )
21 Midazolam Benzodiazepine Short acting Sleep inducing Easy to use (even nasal route directly after birth) On-label for sedation in the NICU No loading dose Maintenance dose: <32 weeks: 0.03 mg/kg/hr >32 weeks: 0.06 mg/kg/hr Disadvantages?
22 Disadvantages Midazolam
23 Propofol Relatively new drug in neonatal care Lipid soluable sedative / hypnotic agent Extensively used in older children and adults Advantages Easy to use Rapidly acting Disadvantages Lack of extensive knowledge in preterm newborns Safety unknown (propofol infusion syndrome?) Probable hypotensive side effect No analgesic effect
24 Propofol Pediatrics 2007 RCT : N = 33 vs N = 30 Conclusion: Propofol is more effective, more rapid in action and easier to use compared to morphine, atropine and suxamethonium.
25 INSURE Pediatrics 2007 Neonates received 1 mg/kg propofol before intubation for INSURE procedure
26 Hypotension in 39% of patients Propofol
27 Total cmulative dose of propfol in mg/kg Propofol dose finding 7,00 6,00 5,00 4,00 3,00 2,00 1,00 0,00 1,00 1,00 1,00 1,00 1,00 1,50 1,50 1,50 1,50 1,50 2,00 2,00 2,00 2,00 2,00 2,00 2,00 2,00 2,00 2,00 1,75 1,75 1,75 1,75 1,75 Starting dose of propofol in mg/kg De Kort et al. PAS Toronto 2018
28 Propofol dose finding - With increasing dose ( mg/kg), sedation improves - But also higher risk for side-effects - Adequate dose in individual patient can not be predicted De Kort et al. PAS Toronto 2018
29 Propofol?? Thewissen et al. Pediatr Res. 2018
30 Ketamine NMDA receptor antagonist Often used in pediatric anesthesia Short duration of action Studies on safety are lacking Potential adverse effects on the developing central nervous system Induction of neuronal cell death If used in painful situations it might be neuroprotective(!?)
31 Comparative trials...
32 Comparative trials... Propofol (+ atropine) vs Atracurium + Sufentanil (+ atropine) N=173 Prolonged desaturation = Underpowered for other conclusions Durrmeyer et al. JAMA 2018
33 MIST RCT Newborns weeks MIST Propofol vs no-premedication Dekker et al. ADC 2018
34 MIST Propofol vs no-premedication Comfort scores <14 76% 22% Desaturation < 85% 91% 69% Nasal ventilation 93% 47% Dekker et al. ADC 2018
35 sedatives in neonates? Use guidelines + Think about the basics...
36 Kearns et al, NEJM 2003 hepatic Body composition Formula dependent renal
37 CRITICAL ILLNESS INFLAMMATION DEVELOPMENTAL PHARMACOLOGY WHOLE BODY ARTIFICIAL SUPPORT DEVICES PHARMACOGENETICS PHARMACOKINETICS / PHARMACODYNAMICS ELBW - OBESITY Allegaert, Simons. et al. Eur J Pharmaceutical sciences 2017
38 AUTOMATED MULTIMODAL ASSESSMENT OF INFANTS PAIN / DISTRESS Facial expression Body movements Physiological data Crying sounds AUTOMATED ANALYSIS movement tracking total pain score thresh Continuous pain monitoring Abstract, PAS meeting San Fransisco 2017
39 Multi model assessment
40 Sedation: personalized medicine! In general for all sedation and analgesia: The amount and intensity of treatment depends on the specific patient and the specific condition It needs to be titrated to the individuals needs
41 Thank you very much for your attention!
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