Developmental changes in morphine clearance across the entire paediatric age range are best described by a bodyweight-dependent exponent model

Clinical Drug Investigation

Volumn 33, Issue 7, 2013, Pages 523-534

  Wang, Chenguang ^a,b   Sadhavisvam, Senthilkumar ^c,d   Krekels, Elke H J ^a,b   Dahan, Albert ^e   Tibboel, Dick ^b   Danhof, Meindert ^a   Vinks, Alexander A ^c,d   Knibbe, Catherijne A J ^a,b,f  

^a LEIDEN UNIVERSITY   (Netherlands)

^b SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d UNIVERSITY OF CINCINNATI   (United States)

^e LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^f ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

MORPHINE; MORPHINE 3 GLUCURONIDE;

ADOLESCENT; ADULT; ALLOMETRY; ANALGESIC ACTIVITY; ARTICLE; BODY SIZE; BODY WEIGHT; BODY WEIGHT DEPENDENT EXPONENT MODEL; CHILD; CHILD DEVELOPMENT; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG GLUCURONIDATION; FEMALE; GROUPS BY AGE; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; NEWBORN; PLASMA CONCENTRATION-TIME CURVE; POPULATION MODEL; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SIGMOID;

ANALGESICS, OPIOID; BODY WEIGHT; CHILD, PRESCHOOL; HUMANS; INFANT; INFANT, NEWBORN; MODELS, BIOLOGICAL; MORPHINE;

EID: 84879809809     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-013-0097-6     Document Type: Article

References (30)

1. Krekels EH, Tibboel D, Danhof M, Knibbe CA. Prediction of morphine clearance in the paediatric population: how accurate are the available pharmacokinetic models? Clin Pharmacokinet. 2012;51(11):695-709. doi: 10.1007/s40262-012-0006-9.
2. Bouwmeester NJ, Anderson BJ, Tibboel D, Holford NH. Developmental pharmacokinetics of morphine and its metabolites in neonates, infants and young children. Br J Anaesth. 2004;92(2):208-17.
3. Anand KJ, Anderson BJ, Holford NH, Hall RW, Young T, Shephard B, 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. doi: aen24810.1093/bja/aen248.
4. Knibbe CA, Krekels EH, van den Anker JN, DeJongh J, Santen GW, van Dijk M, et al. Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin Pharmacokinet. 2009;48(6):371-85. doi: 10.2165/00003088-200948060-000033.
5. Krekels EH, van Hasselt JG, Tibboel D, Danhof M, Knibbe CA. Systematic evaluation of the descriptive and predictive performance of paediatric morphine population models. Pharm Res. 2011;28(4):797-811. doi: 10.1007/s11095-010-0333- 1.
6. Mahmood I. Prediction of drug clearance in children from adults: a comparison of several allometric methods. Br J Clin Pharmacol. 2006;61(5):545-57. doi: BCP262210.1111/j.1365-2125.2006.02622.x.
7. Mahmood I. Prediction of drug clearance in children: impact of allometric exponents, body weight, and age. Ther Drug Monit. 2007;29(3):271-8. doi: 10.1097/FTD.0b013e318042d3c400007691-200706000-00002.
8. Bonate PL. The effect of collinearity on parameter estimates in nonlinear mixed effect models. Pharm Res. 1999;16(5):709-17.
9. Khandelwal A, et al. Influence of correlated covariates on predictive performance for different models. 2011; Abstr 2220:20, 2011.
10. Krekels EH, DeJongh J, van Lingen RA, van der Marel CD, Choonara I, Lynn AM, et al. Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants and children. Clin Pharmacokinet. 2011;50(1):51-63. doi: 10.2165/11536750-000000000-00000.
11. Wang C, Peeters MY, Allegaert K, Blusse van Oud-Alblas HJ, Krekels EH, Tibboel D, et al. A bodyweight-dependent allometric exponent for scaling clearance across the human life-span. Pharm Res. 2012. doi: 10.1007/s11095-012- 0668-x.
12. Bartelink IH, Boelens JJ, Bredius RG, Egberts AC, Wang C, Bierings MB, et al. Body weight-dependent pharmacokinetics of busulfan in paediatric haematopoietic stem cell transplantation patients: towards individualized dosing. Clin Pharmacokinet. 2012;51(5):331-45. doi: 10.2165/11598180-000000000- 00000.
13. van Dijk M, Bouwmeester NJ, Duivenvoorden HJ, Koot HM, Tibboel D, Passchier J, et al. Efficacy of continuous 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.
14. Simons SH, van Dijk M, van Lingen RA, Roofthooft D, Duivenvoorden HJ, Jongeneel N, et al. Routine morphine infusion in preterm newborns who received ventilatory support: a randomized controlled trial. JAMA. 2003;290(18):2419-27. doi: 10.1001/jama.290.18.2419.
15. van Lingen RA. Pain assessment and analgesia in the newborn: an integrated approach. Rotterdam: Erasmus University; 2000.
16. van der Marel CD, Peters JW, Bouwmeester NJ, Jacqz-Aigrain E, van den Anker JN, Tibboel D. Rectal acetaminophen does not reduce morphine consumption after major surgery in young infants. Br J Anaesth. 2007;98(3):372-9. doi: 10.1093/bja/ael371.
17. Lynn AM, Nespeca MK, Bratton SL, Shen DD. Intravenous morphine in postoperative infants: intermittent bolus dosing versus targeted continuous infusions. Pain. 2000;88(1):89-95.
18. Choonara I, Lawrence A, Michalkiewicz A, Bowhay A, Ratcliffe J. Morphine metabolism in neonates and infants. Br J Clin Pharmacol. 1992;34(5):434-7.
19. Sadhasivam S, Krekels EH, Chidambaran V, Esslinger HR, Ngamprasertwong P, Zhang K, et al. Morphine clearance in children: does race or genetics matter? J Opioid Manage. 2012;8(4):217-26. doi: 10.5055/jom.2012.0119.
20. Sarton E, Olofsen E, Romberg R, den Hartigh J, Kest B, Nieuwenhuijs D, et al. Sex differences in morphine analgesia: an experimental study in healthy volunteers. Anesthesiology. 2000;93(5):1245-54; discussion 6A.
21. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007;82(1):17-20. doi: 610024110.1038/sj.clpt.6100241.
22. Brendel K, Comets E, Laffont C, Laveille C, Mentre F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23(9):2036-49. doi: 10.1007/s11095-006-9067-5.
23. Penson RT, Joel SP, Clark S, Gloyne A, Slevin ML. Limited phase I study of morphine-3-glucuronide. J Pharm Sci. 2001;90(11):1810-6.
24. Strassburg CP, Strassburg A, Kneip S, Barut A, Tukey RH, Rodeck B, et al. Developmental aspects of human hepatic drug glucuronidation in young children and adults. Gut. 2002;50(2):259-65.
25. Edginton AN, Schmitt W, Voith B, Willmann S. A mechanistic approach for the scaling of clearance in children. Clin Pharmacokinet. 2006;45(7):683-704.
26. Zaya MJ, Hines RN, Stevens JC. Epirubicin glucuronidation and UGT2B7 developmental expression. Drug Metab Dispos Biol Fate Chem. 2006;34(12):2097- 101. doi: 10.1124/dmd.106.011387.
27. Krekels EHJ, Neely M, Panoilia E, Tibboel D, Capparelli E, Danhof M, et al. From pediatric covariate model to semiphysiological function for maturation: part I-extrapolation of a covariate model from morphine to zidovudine. CPT: Pharmacomet Syst Pharmacol. 2012;1:e9. doi: http://www.nature.com/psp/journal/ v1/n10/suppinfo/psp201211s1.html.
28. Krekels EHJ, Johnson TN, den Hoedt SM, Rostami-Hodjegan A, Danhof M, Tibboel D, et al. From pediatric covariate model to semiphysiological function for maturation: Part II-sensitivity to physiological and physicochemical properties. CPT Pharmacomet Syst Pharmacol. 2012;1:e10.
29. Savic RM, Karlsson MO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11(3):558-69. doi: 10.1208/s12248-009-9133-0.
30. Ince I, de Wildt SN, Wang C,0020Peeters MY, Burggraaf J, Jacqz-Aigrain E, et al. A novel maturation function for clearance of the cytochrome P450 3A substrate midazolam from preterm neonates to adults. Clin Pharmacokinet. 2013. doi: 10.1007/s40262-013-0050-0.