Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants and children

Clinical Pharmacokinetics

Volumn 50, Issue 1, 2011, Pages 51-63

  Krekels, Elke H J ^a,b   DeJongh, Joost ^a,c   Van Lingen, Richard A ^d   Van Der Marel, Caroline D ^b   Choonara, Imti ^e   Lynn, Anne M ^f   Danhof, Meindert ^a   Tibboel, Dick ^b   Knibbe, Catherijne A J ^a,b,g  

^a LEIDEN UNIVERSITY   (Netherlands)

^b SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^c LAP and P Consultants BV   (Netherlands)

^d ISALA HOSPITAL   (Netherlands)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^f UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^g ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

Children; Infants; Metabolism; Morphine, pharmacokinetics; Neonates; Pharmacokinetic modelling; Population pharmacokinetics

Indexed keywords

MORPHINE; MORPHINE 3 GLUCURONIDE; MORPHINE 6 GLUCURONIDE;

ANALYTICAL ERROR; ARTICLE; BOOTSTRAPPING; CONTINUOUS HEMOFILTRATION; DATA ANALYSIS; DRUG CLEARANCE; EXTRACORPOREAL OXYGENATION; HUMAN; INFANT; MAJOR CLINICAL STUDY; NEWBORN; POPULATION MODEL; POSTOPERATIVE PERIOD; PREDICTION AND FORECASTING; PRIORITY JOURNAL; VALIDATION PROCESS; VENTILATED PATIENT;

HUMANS; INFANT; INFANT, NEWBORN; INFANT, PREMATURE; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; MORPHINE; MORPHINE DERIVATIVES; REPRODUCIBILITY OF RESULTS;

EID: 78649928757     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11536750-000000000-00000     Document Type: Article

References (40)

1. Brendel K, Dartois C, Comets E, et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin Pharmacokinet 2007; 46 (3): 221-34.
2. Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by pop- ulation methods and modelling. Clin Pharmacokinet 2008; 47 (4): 231-43.
3. 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 (5-6): 316-20.
4. Knibbe CA, Krekels EH, van den Anker JN, et al. Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin Phar-macokinet 2009; 48 (6): 371-85.
5. Van Lingen RA. Pain assessment and analgesia in the newborn: an integrated approach [thesis]. Rotterdam: Erasmus University, 2000.
6. Van der Marel CD, Peters JW, Bouwmeester NJ, et al. Rectal acetaminophen does not reduce morphine consumption after major surgery in young infants. Br J Anaesth 2007; 98 (3): 372-9.
7. Lynn AM, Nespeca MK, Bratton SL, et al. Intravenous morphine in post- operative infants: intermittent bolus dosing versus targeted continuous infusions. Pain 2000; 88 (1): 89-95.
8. Choonara I, Lawrence A, Michalkiewicz A, et al. Morphine metabolism in neonates and infants. Br J Clin Pharmacol 1992; 34 (5): 434-7.
9. Peters JW, Anderson BJ, Simons SH, et al. Morphine pharmacokinetics during venoarterial extracorporeal membrane oxygenation in neonates. Intensive Care Med 2005; 31 (2): 257-63.
10. Peters JW, Anderson BJ, Simons SH, et al. Morphine metabolite pharmaco- kinetics during venoarterial extra corporeal membrane oxygenation in neo-nates. Clin Pharmacokinet 2006; 45 (7): 705-14.
11. Hanekamp MN. Short and long term studies in neonates treated with extra- corporeal membrane oxygenation (ECMO) [thesis]. Rotterdam: Erasmum University, 2005.
12. van DijkM,Bouwmeester NJ, Duivenvoorden HJ,etal. Efficacyofcontinuous versus intermittent morphine administration after major surgery in 0-3-year-old infants; a double-blind randomized controlled trial. Pain 2002; 98 (3): 305-13.
13. Simons SH, van Dijk M, Van Lingen RA, et al. Routine morphine infusion in preterm newborns who received ventilatory support: a randomized controlled trial. JAMA 2003; 290 (18): 2419-27.
14. Brendel K, Comets E, Laffont C, et al. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 2006; 23 (9): 2036-49.
15. Comets E, Brendel K, Mentre F. Computing normalised prediction distribu- tion errors to evaluate nonlinear mixed-effect models: the NPDE add-on package for R. Comput Methods Programs Biomed 2008; 90 (2): 154-66.
16. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 2005; 79 (3): 241-57.
17. 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 (5): 680-9.
18. Bouwmeester NJ, Anderson BJ, Tibboel D, et al. Developmental pharmaco- kinetics of morphine and its metabolites in neonates, infants and young children. Br J Anaesth 2004; 92 (2): 208-17.
19. Saarenmaa E, Neuvonen PJ, Rosenberg P, et al. Morphine clearance and ef- fects in newborn infants in relation to gestational age. Clin Pharmacol Ther 2000; 68 (2): 160-6.
20. Scott CS, Riggs KW, Ling EW, et al. Morphine pharmacokinetics and pain assessment in premature newborns. J Pediatr 1999; 135 (4): 423-9.
21. Lynn A, Nespeca MK, Bratton SL, et al. Clearance of morphine in post- operative infants during intravenous infusion: the influence of age and surgery. Anesth Analg 1998; 86 (5): 958-63.
22. Barrett DA, Barker DP, Rutter N, et al. Morphine, morphine-6-glucuronide and morphine-3-glucuronide pharmacokinetics in newborn infants receiving diamorphine infusions. Br J Clin Pharmacol 1996; 41 (6): 531-7.
23. Mikkelsen S, Feilberg VL, Christensen CB, et al. Morphine pharmacokine- tics in premature and mature newborn infants. Acta Paediatr 1994; 83 (10): 1025-8.
24. Hartley R, Green M, QuinnM,et al. Pharmacokinetics of morphine infusion in premature neonates. Arch Dis Child 1993; 69 (1 Spec. No.): 55-8.
25. Pokela ML, Olkkola KT, Seppala T, et al. Age-related morphine kinetics in infants. Dev Pharmacol Ther 1993; 20 (1-2): 26-34.
26. McRorie TI, Lynn AM, Nespeca MK, et al. The maturation of morphine clearance and metabolism. Am J Dis Child 1992; 146 (8): 972-6.
27. Chay PC, Duffy BJ, Walker JS. Pharmacokinetic-pharmacodynamic re- lationships of morphinein neonates. Clin Pharmacol Ther 1992;51 (3): 334-42.
28. Choonara I, Ekbom Y, Lindstrom B, et al. Morphine sulphation in children. Br J Clin Pharmacol 1990; 30 (6): 897-900.
29. Olkkola KT, Maunuksela EL, Korpela R, et al. Kinetics and dynamics of postoperative intravenous morphine in children. Clin Pharmacol Ther 1988; 44 (2): 128-36.
30. Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur J Pediatr 2006; 165 (12): 819-29.
31. Tafuri G, Trotta F, Leufkens HG, et al. Off-label use of medicines in children: can available evidence avoid useless paediatric trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease. Eur J Clin Pharmacol 2009; 65 (2): 209-16.
32. De Wildt SN, Knibbe CA. Knowledge of developmental pharmacology and modeling approaches should be used to avoid useless trials in children. Eur J Clin Pharmacol 2009; 65 (8): 849-50.
33. Anderson BJ, Merry AF. Data sharing for pharmacokinetic studies. Paediatr Anaesth 2009; 19 (10): 1005-10.
34. Mulla H, Pooboni S. Population pharmacokinetics of vancomycin in patients receiving extracorporeal membrane oxygenation. Br J Clin Pharmacol 2005; 60 (3): 265-75.
35. Mulla H, McCormack P, Lawson G, et al. Pharmacokinetics of midazolam in neonates undergoing extracorporeal membrane oxygenation. Anesthesiology 2003; 99 (2): 275-82.
36. Buck ML. Pharmacokinetic changes during extracorporeal membrane oxyge- nation: implications for drug therapy of neonates. Clin Pharmacokinet 2003; 42 (5): 403-17.
37. Mulla H, Nabi F, Nichani S, et al. Population pharmacokinetics of theo- phylline during paediatric extracorporeal membrane oxygenation. Br J Clin Pharmacol 2003; 55 (1): 23-31.
38. Blijdorp K, Cransberg K, Wildschut ED, et al. Haemofiltration in newborns treated with extracorporeal membrane oxygenation: a case-comparison study. Crit Care 2009; 13 (2): R48.
39. Erasmus MC-Sophia Children's Hospital. Morphine vs intravenous acetamin- ophen after surgery in patients under the age of1 year [Nederlands Trialregister identifier NTR1438; online]. Available from URL: http://www.trialregister.nl/ trialreg/admin/rctview.asp?TC=1438 [Accessed 2010 Oct 20].
40. Erasmus MC-Sophia Children's Hospital. Intravenous morphine versus in- travenous paracetamol in children on ECMO [Nederlands Trialregister identifier NTR2180; online]. Available from URL: http://www.trialregister. nl/trialreg/admin/rctview.asp?TC=2180 [Accessed 2010 Oct 20].