409
Views
1
CrossRef citations to date
0
Altmetric
Review

Pharmacokinetic considerations for pediatric patients receiving analgesia in the intensive care unit; targeting postoperative, ECMO and hypothermia patients

, , , , , , & show all
Pages 417-428 | Received 22 Apr 2017, Accepted 03 Apr 2018, Published online: 11 Apr 2018

References

  • Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987;317:1321–1329.
  • Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful procedures in children. Arch Pediatr Adolesc Med. 1998;152:147–149.
  • Berde CB, Jaksic T, Lynn AM, et al. Anesthesia and analgesia during and after surgery in neonates. Clin Ther. 2005;27:900–921.
  • Page GG. Are there long-term consequences of pain in newborn or very young infants? J Perinat Educ. 2004;13:10–17.
  • Taddio A, Katz J, Ilersich AL, et al. Effect of neonatal circumcision on pain response during subsequent routine vaccination. Lancet. 1997;349:599–603.
  • de Graaf J, van Lingen RA, Valkenburg AJ, et al. Does neonatal morphine use affect neuropsychological outcomes at 8 to 9 years of age? Pain. 2013;154:449–458.
  • de Graaf J, van Lingen RA, Simons SH, et al. Long-term effects of routine morphine infusion in mechanically ventilated neonates on children’s functioning: five-year follow-up of a randomized controlled trial. Pain. 2011;152:1391–1397.
  • Scholten W. Developing ‘fully evidenced’ paediatric pain guidelines. Eur J Hosp Pharm. 2013;20:262–263.
  • www.who.int.: Geneva: WHO; 2012 cited 2017 Dec 12. Available from: http://apps.who.int/iris/bitstream/10665/44540/1/9789241548120_Guidelines.pdf.
  • Hall RW, Anand KJS. Pain management in newborns. Clin Perinatol. 2014;41:895–924.
  • Poh YN, Poh PF, Buang SN, et al. Sedation guidelines, protocols, and algorithms in PICUs: a systematic review. Pediatr Crit Care Med. 2014;15:885–892.
  • Jebaraj B, Maitra S, Baidya DK, et al. Intravenous paracetamol reduces postoperative opioid consumption after orthopedic surgery: a systematic review of clinical trials. Pain Res Treat. 2013;2013:402510.
  • van Dijk M, de Boer JB, Koot HM, et al. The reliability and validity of the COMFORT scale as a postoperative pain instrument in 0 to 3-year-old infants. Pain. 2000;84:367–377.
  • Boerlage AA, Ista E, Duivenvoorden HJ, et al. The COMFORT behaviour scale detects clinically meaningful effects of analgesic and sedative treatment. Eur J Pain. 2015;19:473–479.
  • Matic M, de Wildt SN, Elens L, et al. SLC22A1/OCT1 genotype affects O-desmethyltramadol exposure in newborn infants. Ther Drug Monit. 2016;38:487–492.
  • Bradford LD. CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants. Pharmacogenomics. 2002;3:229–243.
  • Foulkes T, Wood JN. Mechanisms of cold pain. Channels (Austin). 2007;1:154–160.
  • Rutkove SB. Effects of temperature on neuromuscular electrophysiology. Muscle Nerve. 2001;24:867–882.
  • Wang C, Sadhavisvam S, Krekels EH, et al. Developmental changes in morphine clearance across the entire paediatric age range are best described by a bodyweight-dependent exponent model. Clin Drug Investig. 2013;33:523–534.
  • Krekels EH, Tibboel D, de Wildt SN, et al. Evidence-based morphine dosing for postoperative neonates and infants. Clin Pharmacokinet. 2014;53:553–563.
  • Anand KJ, Stevens BJ, McGrath P. Pain in neonates and infants. 3rd ed. New York, United States: Elsevier; 2007.
  • Griffin JP. The textbook of pharmaceutical medicine. Hoboken, New Jersey, United States: Wiley-Blackwell; 2009.
  • Yamamoto Y, Valitalo PA, Wong YC, et al. Prediction of human CNS pharmacokinetics using a physiologically-based pharmacokinetic modeling approach. Eur J Pharm Sci. 2018;112:168–179.
  • Lam J, Koren G. P-glycoprotein in the developing human brain: A review of the effects of ontogeny on the safety of opioids in neonates. Ther Drug Monit. 2014;36:699–705.
  • Fernandez E, Perez R, Hernandez A, et al. Factors and mechanisms for pharmacokinetic differences between pediatric population and adults. Pharmaceutics. 2011;3:53–72.
  • Allegaert K, Simons SHP, Tibboel D, et al. Non-maturational covariates for dynamic systems pharmacology models in neonates, infants, and children: filling the gaps beyond developmental pharmacology. Eur J Pharm Sci. 2017
  • Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–1167.
  • van Den Anker JN, Schwab M, Kearns GL. Developmental pharmacokinetics. Handb Exp Pharmacol. 2011;205:51–75.
  • Mooij MG, Schwarz UI, de Koning BA, et al. Ontogeny of human hepatic and intestinal transporter gene expression during childhood: age matters. Drug Metab Dispos. 2014;42:1268–1274.
  • Blake MJ, Castro L, Leeder JS, et al. Ontogeny of drug metabolizing enzymes in the neonate. Semin Fetal Neonatal Med. 2005;10:123–138.
  • Allegaert K. Tailored tools to improve pharmacotherapy in infants. Expert Opin Drug Metab Toxicol. 2014;10:1069–1078.
  • Krekels EH, Tibboel D, Knibbe CA. Pediatric pharmacology: current efforts and future goals to improve clinical practice. Expert Opin Drug Metab Toxicol. 2015;11:1679–1682.
  • Wang C, Allegaert K, Tibboel D, et al. Population pharmacokinetics of paracetamol across the human age-range from (pre)term neonates, infants, children to adults. J Clin Pharmacol. 2014;54:619–629.
  • Baarslag MA, Allegaert K, Knibbe CA, et al. Pharmacological sedation management in the paediatric intensive care unit. J Pharm Pharmacol. 2016;69:498-513.
  • Krekels EH, van Ham S, Allegaert K, et al. Developmental changes rather than repeated administration drive paracetamol glucuronidation in neonates and infants. Eur J Clin Pharmacol. 2015;71:1075–1082.
  • Vet NJ, de Hoog M, Tibboel D, et al. The effect of inflammation on drug metabolism: a focus on pediatrics. Drug Discov Today. 2011;16:435–442.
  • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur J Pediatr. 2006;165:741–746.
  • Wildschut ED, de Wildt SN, Mathot RAA, et al. Effect of hypothermia and extracorporeal life support on drug disposition in neonates. Semin Fetal Neonatal Med. 2013;18:23–27.
  • Zwiers AJ, de Wildt SN, Hop WC, et al. Acute kidney injury is a frequent complication in critically ill neonates receiving extracorporeal membrane oxygenation: a 14-year cohort study. Crit Care. 2013;17:R151.
  • Leeder JS, Kearns GL. Interpreting pharmacogenetic data in the developing neonate: the challenge of hitting a moving target. Clin Pharmacol Ther. 2012;92:434–436.
  • Allegaert K, Van Den Anker JN, De Hoon JN, et al. Covariates of tramadol disposition in the first months of life. Br J Anaesth. 2008;100:525–532.
  • Orliaguet G, Hamza J, Couloigner V, et al. A case of respiratory depression in a child with ultrarapid CYP2D6 metabolism after tramadol. Pediatrics. 2015;135:e7535.
  • Kelly LE, Rieder M, van den Anker J, et al. More codeine fatalities after tonsillectomy in North American children. Pediatrics. 2012;129:e13437.
  • Roka A, Melinda KT, Vasarhelyi B, et al. Elevated morphine concentrations in neonates treated with morphine and prolonged hypothermia for hypoxic ischemic encephalopathy. Pediatrics. 2008;121:e844–9.
  • Harris J, Ramelet AS, van Dijk M, et al. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016;42:972–986.
  • Knosgaard KR, Foster DJ, Kreilgaard M, et al. Pharmacokinetic models of morphine and its metabolites in neonates: systematic comparisons of models from the literature, and development of a new meta-model. Eur J Pharm Sci. 2016;92:117–130.
  • Crellin DJ, Harrison D, Santamaria N, et al. Systematic review of the face, legs, activity, cry and consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015;156:2132–2151.
  • Krechel SW, Bildner J. CRIES: a new neonatal postoperative pain measurement score. Initial testing of validity and reliability. Paediatr Anaesth. 1995;5:53–61.
  • Matic M, Norman E, Rane A, et al. Effect of UGT2B7900G>A (−842G>A; rs7438135) on morphine glucuronidation in preterm newborns: results from a pilot cohort. Pharmacogenomics. 2014;15:1589–1597.
  • Matic M, Simons SH, van Lingen RA, et al. Rescue morphine in mechanically ventilated newborns associated with combined OPRM1 and COMT genotype. Pharmacogenomics. 2014;15:1287–1295.
  • Meesters NJ, van Dijk M, Knibbe CA, et al. Infants operated on for necrotizing enterocolitis: towards evidence-based pain guidelines. Neonatology. 2016;110:190–197.
  • Shay JE, Kattail D, Morad A, et al. The postoperative management of pain from intracranial surgery in pediatric neurosurgical patients. Paediatr Anaesth. 2014;24:724–733.
  • Anand KJS, Hickey PR. Halothane–morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. New England J Med. 1992.
  • Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131–157.
  • Ceelie I, de Wildt SN, van Dijk M, et al. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery a randomized controlled trial. Jama-Journal Am Med Assoc. 2013;309:149–154.
  • Anderson BJ, Pons G, Autret-Leca E, et al. Pediatric intravenous paracetamol (propacetamol) pharmacokinetics: a population analysis. Paediatr Anaesth. 2005;15:282–292.
  • Kokki H. Ketoprofen pharmacokinetics, efficacy, and tolerability in pediatric patients. Paediatr Drugs. 2010;12:313–329.
  • Rollason V, Desmeules JA. Use of metamizole in children and the risk of agranulocytosis: is the benefit worth the risk? Eur J Anaesthesiol. 2015;32:837–838.
  • Schnabel A, Reichl SU, Meyer-Friessem C, et al. Tramadol for postoperative pain treatment in children. Cochrane Database Syst Rev. 2015;CD009574.
  • Schnabel A, Reichl SU, Zahn PK, et al. Nalbuphine for postoperative pain treatment in children. Cochrane Database Syst Rev.. 2014;CD009583.
  • Baley K, Michalov K, Kossick MA, et al. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. Aana J. 2014;82:53–64.
  • Monk JP, Beresford R, Ward A. Sufentanil. A review of its pharmacological properties and therapeutic use. Drugs. 1988;36:286–313.
  • Lundeberg S, Roelofse JA. Aspects of pharmacokinetics and pharmacodynamics of sufentanil in pediatric practice. Paediatr Anaesth. 2011;21:274–279.
  • Greeley WJ, de Bruijn NP. Changes in sufentanil pharmacokinetics within the neonatal period. Anesth Analg. 1988;67:86–90.
  • Pokorna P, Wildschut ED, Vobruba V, et al. The impact of hypothermia on the pharmacokinetics of drugs used in neonates and young infants. Curr Pharm Des. 2015;21:5705–5724.
  • van den Broek MP, Groenendaal F, Egberts AC, et al. Effects of hypothermia on pharmacokinetics and pharmacodynamics: a systematic review of preclinical and clinical studies. Clin Pharmacokinet. 2010;49:277–294.
  • Meurs KV, Lally KP, Peek G, et al. ECMO; extracorporeal cardiopulmonary support in critical care. 3rd ed. Extracorporeal Life Support Organization; 2005. Ann Arbor, MI.
  • Mulla H, Lawson G, Woodland ED, et al. Effects of neonatal extracorporeal membrane oxygenation circuits on drug disposition. Curr Ther Res Clin Exp. 2000;61:838–848.
  • Wildschut ED, van Saet A, Pokorna P, et al. The impact of extracorporeal life support and hypothermia on drug disposition in critically Ill infants and children. Pediatr Clin North Am. 2012;59:1184–1204.
  • Shekar K, Fraser JF, Smith MT, et al. Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care. 2012;27:741.e9-.e18.
  • Dagan O, Klein J, Gruenwald C, et al. Preliminary studies of the effects of extracorporeal membrane-oxygenator on the disposition of common pediatric drugs. Ther Drug Monit. 1993;15:263–266.
  • Peters JW, Anderson BJ, Simons SH, et al. Morphine metabolite pharmacokinetics during venoarterial extra corporeal membrane oxygenation in neonates. Clin Pharmacokinet. 2006;45:705–714.
  • Association of Paediatric Anaesthetists of Great B, Ireland. Good practice in postoperative and procedural pain management, 2nd edition. Paediatr Anaesth. 2012;22(Suppl 1):1–79.
  • Lucas SS, Nasr VG, Ng AJ, et al. Pediatric cardiac intensive care society 2014 consensus statement: pharmacotherapies in cardiac critical care: sedation, analgesia and muscle relaxant. Pediatr Crit Care Med. 2016;17:S3–S15.
  • Dagan O, Klein J, Bohn D, et al. Morphine pharmacokinetics in children following cardiac surgery: effects of disease and inotropic support. J Cardiothorac Vasc Anesth. 1993;7:396–398.
  • Lynn A, Nespeca MK, Bratton SL, et al. Clearance of morphine in postoperative infants during intravenous infusion: the influence of age and surgery. Anesth Analg. 1998;86:958–963.
  • Elkomy MH, Drover DR, Glotzbach KL, et al. Pharmacokinetics of morphine and its metabolites in infants and young children after congenital heart surgery. Aaps J. 2016;18:124–133.
  • van Saet A, de Wildt SN, Knibbe CA, et al. The effect of adult and pediatric cardiopulmonary bypass on pharmacokinetic and pharmacodynamic parameters. Curr Clin Pharmacol. 2013;8:297–318.
  • Valkenburg AJ, Calvier EA, van Dijk M, et al. Pharmacodynamics and pharmacokinetics of morphine after cardiac surgery in children with and without down syndrome. Pediatr Crit Care Med. 2016;17:930-938.
  • Rigby-Jones AE, Priston MJ, Sneyd JR, et al. Remifentanil-midazolam sedation for paediatric patients receiving mechanical ventilation after cardiac surgery. Br J Anaesth. 2007;99:252–261.
  • Sam WJ, Hammer GB, Drover DR. Population pharmacokinetics of remifentanil in infants and children undergoing cardiac surgery. BMC Anesthesiol. 2009;9.
  • Kleiber N, de Wildt SN, Cortina G, et al. Clonidine as a first-line sedative agent after neonatal cardiac surgery: retrospective cohort study. Pediatr Crit Care Med. 2016;17:332–341.
  • Wolf A, McKay A, Spowart C, et al. Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study. Health Technol Assess. 2014;18:1–212.
  • Potts AL, Larsson P, Eksborg S, et al. Clonidine disposition in children; a population analysis. Paediatr Anaesth. 2007;17:924–933.
  • Su F, Gastonguay MR, Nicolson SC, et al. Dexmedetomidine pharmacology in neonates and infants after open heart surgery. Anesth Analg. 2016;122:1556–1566.
  • Hall RI. Cardiopulmonary bypass and the systemic inflammatory response: effects on drug action. J Cardiothorac Vasc Anesth. 2002;16:83–98.
  • Ji B, Undar A. An evaluation of the benefits of pulsatile versus nonpulsatile perfusion during cardiopulmonary bypass procedures in pediatric and adult cardiac patients. Asaio J. 2006;52:357–361.
  • Boehne M, Sasse M, Karch A, et al. Systemic inflammatory response syndrome after pediatric congenital heart surgery: incidence, risk factors, and clinical outcome. J Card Surg. 2017;32:116–125.
  • Vet NJ, Brussee JM, de Hoog M, et al. Inflammation and organ failure severely affect midazolam clearance in critically ill children. Am J Respir Crit Care Med. 2016.
  • Hammaren E, Rosenberg PH, Hynynen M. Coating of extracorporeal circuit with heparin does not prevent sequestration of propofol in vitro. Br J Anaesth. 1999;82:38–40.
  • Koren G, Crean P, Klein J. Sequestration of fentanyl by the cardiopulmonary bypass (CPBP). Eur J Clin Pharmacol. 1984;27:51–56.
  • Anand KJ, Willson DF, Berger J, et al. Tolerance and withdrawal from prolonged opioid use in critically ill children. Pediatrics. 2010;125:e1208–25.
  • Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000;28:2122–2132.
  • Vet NJ, de Wildt SN, Verlaat CW, et al. A randomized controlled trial of daily sedation interruption in critically ill children. Intensive Care Med. 2016;42:233–244.
  • Ince I, de Wildt SN, Tibboel D, et al. Tailor-made drug treatment for children: Creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today. 2009;14:316–320.
  • Aarons L, Ogungbenro K. Optimal design of pharmacokinetic studies. Basic Clin Pharmacol Toxicol. 2010;106:250–255.
  • de Cock RF, Piana C, Krekels EH, et al. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(Suppl 1):5–16.
  • Mahmood I. Prediction of drug clearance in premature and mature neonates, infants, and children </=2 years of age: a comparison of the predictive performance of 4 allometric models. J Clin Pharmacol. 2016;56:733–739.
  • Anderson BJ, Holford NH. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet. 2009;24:25–36.
  • Bouwmeester NJ, Anderson BJ, Tibboel D, et al. Developmental pharmacokinetics of morphine and its metabolites in neonates, infants and young children. Br J Anaesth. 2004;92:208–217.
  • Anand KJ, Anderson BJ, Holford NH, et al. Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: secondary results from the NEOPAIN trial. Br J Anaesth. 2008;101:680–689.
  • Knibbe CA, Krekels EH, van den Anker JN, et al. Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin Pharmacokinet. 2009;48:371–385.
  • Krekels EH, van Hasselt JG, Tibboel D, et al. Systematic evaluation of the descriptive and predictive performance of paediatric morphine population models. Pharm Res. 2011;28:797–811.
  • Mian PKC, Tibboel D, Allegaert K. What dose of paracetamol is needed in neonates with pain? Arch of Dis in Childh. 2017. Forthcoming.
  • Standing JF, Howard RF, Johnson A, et al. Population pharmacokinetics of oral diclofenac for acute pain in children. Br J Clin Pharmacol. 2008;66:846–853.
  • van der Marel CD, Anderson BJ, Romsing J, et al. Diclofenac and metabolite pharmacokinetics in children. Paediatr Anaesth. 2004;14:443–451.
  • Bressolle F, Khier S, Rochette A, et al. Population pharmacokinetics of nalbuphine after surgery in children. Br J Anaesth. 2011;106:558–565.
  • Mohammed BS, Engelhardt T, Hawwa AF, et al. The enantioselective population pharmacokinetics of intravenous ketorolac in children using a stereoselective assay suitable for microanalysis. J Pharm Pharmacol. 2015;67:1179–1187.
  • de Cock RF, Allegaert K, Brussee JM, et al. Simultaneous pharmacokinetic modeling of gentamicin, tobramycin and vancomycin clearance from neonates to adults: towards a semi-physiological function for maturation in glomerular filtration. Pharm Res. 2014;31:2643–2654.
  • Mooij MG, de Koning BA, Huijsman ML, et al. Ontogeny of oral drug absorption processes in children. Expert Opin Drug Metab Toxicol. 2012;8:1293–1303.
  • Mooij MG, van Duijn E, Knibbe CA, et al. Successful use of [14C]paracetamol microdosing to elucidate developmental changes in drug metabolism. Clin Pharmacokinet. 2017.
  • Davis PJ, Cook DR, Stiller RL, et al. Pharmacodynamics and pharmacokinetics of high-dose sufentanil in infants and children undergoing cardiac surgery. Anesth Analg. 1987;66:203–208.
  • Valitalo PA, van Dijk M, Krekels EH, et al. Pain and distress caused by endotracheal suctioning in neonates is better quantified by behavioural than physiological items: a comparison based on item response theory modelling. Pain. 2016;157:1611-1617.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.