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Review

Considerations when using pharmacokinetic/pharmacodynamic modeling to determine the effectiveness of simple analgesics in children

, PhD FANZCA FJFICM & , PhD

Bibliography

  • Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev 2013;6:CD010210
  • Korpela R, Korvenoja P, Meretoja OA. Morphine-sparing effect of acetaminophen in pediatric day-case surgery. Anesthesiology 1999;91(2):442-7
  • Morton NS, O’Brien K. Analgesic efficacy of paracetamol and diclofenac in children receiving PCA morphine. Br J Anaesth 1999;82(5):715-17
  • Berde CB, Walco GA, Krane EJ, et al. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop. Pediatrics 2012;129(2):354-64
  • Kossowsky J, Donado C, Berde CB. Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis. Anesthesiology 2015;122(1):150-71
  • Holford NH, Sheiner LB. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokinet 1981;6(6):429-53
  • Krekels EH, Tibboel D, de Wildt SN, et al. Evidence-based morphine dosing for postoperative neonates and infants. Clin Pharmacokinet 2014;53(6):553-63
  • Hill AV. The possible effects of the aggregation of the molecules of haemoglobin on its dissociation curves. J Physiol 1910;14:iv-vii
  • Anderson BJ, Holford NH. Understanding dosing: children are small adults, neonates are immature children. Arch Dis Child 2013;98(9):737-44
  • Benet LZ. A Holy Grail of clinical pharmacology: prediction of drug pharmacokinetics and pharmacodynamics in the individual patient. Clin Pharmacol Ther 2009;86(2):133-4
  • Sheiner LB, Beal SL, Sambol NC. Study designs for dose-ranging. Clin Pharmacol Ther 1989;46(1):63-77
  • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur J Pediatr 2006;165(11):741-6
  • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur J Pediatr 2006;165(12):819-29
  • Duffull S, Waterhouse T, Eccleston J. Some considerations on the design of population pharmacokinetic studies. J Pharmacokinet Pharmacodynam 2005;32(3-4):441-57
  • Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet 2008;47(4):231-43
  • Holford N, Heo YA, Anderson B. A pharmacokinetic standard for babies and adults. J Pharm Sci 2013;102(9):2941-52
  • West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science 1997;276(5309):122-6
  • Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008;48:303-32
  • Holford S, Allegaert K, Anderson BJ, et al. Parent-metabolite pharmacokinetic models for tramadol – tests of assumptions and predictions. J Pharmacol Clin Toxicol 2014;2(1):1023
  • Ross AK, Davis PJ, Dear Gd GL, et al. Pharmacokinetics of remifentanil in anesthetized pediatric patients undergoing elective surgery or diagnostic procedures. Anesth Analg 2001;93(6):1393-401
  • 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(2):252-61
  • Welzing L, Ebenfeld S, Dlugay V, et al. Remifentanil degradation in umbilical cord blood of preterm infants. Anesthesiology 2011;114(3):570-7
  • Johnson TN. The problems in scaling adult drug doses to children. Arch Dis Child 2008;93(3):207-11
  • Edginton AN, Schmitt W, Voith B, et al. A mechanistic approach for the scaling of clearance in children. Clin Pharmacokinet 2006;45(7):683-704
  • 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
  • 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(5):958-63
  • Kauffman RE, Lieh-Lai MW, Uy HG, et al. Enantiomer-selective pharmacokinetics and metabolism of ketorolac in children. Clin Pharmacol Ther 1999;65(4):382-8
  • Anderson BJ, Holford NH. Tips and traps analyzing pediatric PK data. Paediatr Anaesth 2011;21(3):222-37
  • Potts AL, Cheeseman JF, Warman GR. Circadian rhythms and their development in children: implications for pharmacokinetics and pharmacodynamics in anesthesia. Paediatr Anaesth 2011;21(3):238-46
  • Kamali F, Fry JR, Bell GD. Temporal variations in paracetamol absorption and metabolism in man. Xenobiotica 1987;17(5):635-41
  • Halsas M, Hietala J, Veski P, et al. Morning versus evening dosing of ibuprofen using conventional and time-controlled release formulations. Int JPharmaceut 1999;189(2):179-85
  • Clench J, Reinberg A, Dziewanowska Z, et al. Circadian changes in the bioavailability and effects of indomethacin in healthy subjects. Eur J Clin Pharm 1981;20(5):359-69
  • Mustofa M, Suryawati S, Dwiprahasto I, et al. The relative bioavailability of diclofenac with respect to time of administration. Br J Clin Pharm 1991;32(2):246-7
  • Ollagnier M, Decousus H, Cherrah Y, et al. Circadian changes in the pharmacokinetics of oral ketoprofen. Clin Pharmacokinet 1987;12(5):367-78
  • Hull CJ, Van Beem HB, McLeod K, et al. A pharmacodynamic model for pancuronium. Br J Anaesth 1978;50(11):1113-23
  • Sheiner LB, Stanski DR, Vozeh S, et al. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to D-tubocurarine. Clin Pharmacol Ther 1979;25(3):358-71
  • West D, West BJ. Physiologic time: a hypothesis. Phys Life Rev 2013;10(2):210-24
  • Chauhan RD, Idom CB, Noe HN. Safety of ketorolac in the pediatric population after ureteroneocystostomy. J Urol 2001;166(5):1873-5
  • Park JM, Houck CS, Sethna NF, et al. Ketorolac suppresses postoperative bladder spasms after pediatric ureteral reimplantation. Anesth Analg 2000;91(1):11-15
  • Gauthier JC, Finley GA, McGrath PJ. Children’s self-report of postoperative pain intensity and treatment threshold: determining the adequacy of medication. Clin J Pain 1998;14(2):116-20
  • Beyer JE, Denyes MJ, Villarruel AM. The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children. J Pediatr Nurs 1992;7(5):335-46
  • Bieri D, Reeve RA, Champion GD, et al. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain 1990;41(2):139-50
  • Chambers CT, Giesbrecht K, Craig KD, et al. A comparison of faces scales for the measurement of pediatric pain: children’s and parents’ ratings. Pain 1999;83(1):25-35
  • 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(2-3):367-77
  • Beyer JE, McGrath PJ, Berde CB. Discordance between self-report and behavioral pain measures in children aged 3-7 years after surgery. J Pain Symptom Manage 1990;5(6):350-6
  • Berde CB, Sethna NF. Analgesics for the treatment of pain in children. N Engl J Med 2002;347(14):1094-103
  • Breau LM, Finley GA, McGrath PJ, et al. Validation of the Non-communicating Children’s Pain Checklist-Postoperative Version. Anesthesiology 2002;96(3):528-35
  • Walker SM. Biological and neurodevelopmental implications of neonatal pain. Clin Perinatol 2013;40(3):471-91
  • Howard RF, Liossi C. Pain assessment in children. Arch Dis Child 2014;99(12):1123-4
  • Chan PL, Holford NH. Drug treatment effects on disease progression. Annu Rev Pharmacol Toxicol 2001;41:625-59
  • Brown RD, Kearns GL, Wilson JT. Integrated pharmacokinetic-pharmacodynamic model for acetaminophen, ibuprofen, and placebo antipyresis in children. J Pharmacokinet Biopharm 1998;26(5):559-79
  • Lavy JA. Post-tonsillectomy pain: the difference between younger and older patients. Int J Pediatr Otorhinolaryngol 1997;42(1):11-15
  • Murthy P, Laing MR. Dissection tonsillectomy: pattern of post-operative pain, medication and resumption of normal activity. J Laryngol Otol 1998;112(1):41-4
  • Stewart DW, Ragg PG, Sheppard S, et al. The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair. Pediatr Anesth 2012;22(2):136-43
  • Anderson BJ, Holford NH, Woollard GA, et al. Perioperative pharmacodynamics of acetaminophen analgesia in children. Anesthesiology 1999;90(2):411-21
  • Anderson BJ, Woollard GA, Holford NH. Acetaminophen analgesia in children: placebo effect and pain resolution after tonsillectomy. Eur J Clin Pharmacol 2001;57(8):559-69
  • Simmons K, Ortiz R, Kossowsky J, et al. Pain and placebo in pediatrics: a comprehensive review of laboratory and clinical findings. Pain 2014;155(11):2229-35
  • Weimer K, Gulewitsch MD, Schlarb AA, et al. Placebo effects in children: a review. Pediatr Res 2013;74(1):96-102
  • Krummenacher P, Kossowsky J, Schwarz C, et al. Expectancy-induced placebo analgesia in children and the role of magical thinking. J Pain 2014;15(12):1282-93
  • Bjornsson MA, Simonsson US. Modelling of pain intensity and informative dropout in a dental pain model after naproxcinod, naproxen and placebo administration. Br J Clin Pharmacol 2011;71(6):899-906
  • Johr M. Postanaesthesia excitation. Paediatr Anaesth 2002;12(4):308-12
  • Benedetti F. Placebo and endogenous mechanisms of analgesia. Handb Exp Pharmacol 2007(177):393-413
  • Marchand S, Gaumond I. Placebo and nocebo: how to enhance therapies and avoid unintended sabotage to pain treatment. Pain Manag 2013;3(4):285-94
  • Zaccara G, Giovannelli F, Schmidt D. Placebo and nocebo responses in drug trials of epilepsy. Epilepsy Behav 2015;43:128-34
  • Manchikanti L, Pampati V, Damron K. The role of placebo and nocebo effects of perioperative administration of sedatives and opioids in interventional pain management. Pain Physician 2005;8(4):349-55
  • Anderson B, Cranswick N. The placebo (I shall please)--is it so pleasing in children? Paediatr Anaesth 2005;15(10):809-13
  • Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331(6):394-8
  • Sheiner LB. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin Pharmacol Ther 1994;56(3):309-22
  • Hannam J, Anderson BJ. Explaining the acetaminophen-ibuprofen analgesic interaction using a response surface model. Paediatr Anaesth 2011;21(12):1234-40
  • Smith TW, Binning AR, Dahan A. Efficacy and safety of morphine-6-glucuronide (M6G) for postoperative pain relief: a randomized, double-blind study. Eur J Pain 2009;13(3):293-9
  • Sverrisdottir E, Lund TM, Olesen AE, et al. A review of morphine and morphine-6-glucuronide’s pharmacokinetic-pharmacodynamic relationships in experimental and clinical pain. Eur J Pharm Sci 2015;74:45-62
  • Peeters MY, Prins SA, Knibbe CA, et al. Propofol Pharmacokinetics and Pharmacodynamics for Depth of Sedation in Nonventilated Infants after Major Craniofacial Surgery. Anesthesiology 2006;104(3):466-74
  • Williams DG, Patel A, Howard RF. Pharmacogenetics of codeine metabolism in an urban population of children and its implications for analgesic reliability. Br J Anaesth 2002;89(6):839-45
  • Allegaert K, Holford N, Anderson BJ, et al. Tramadol and O-desmethyl tramadol clearance maturation and disposition in humans: a pooled pharmacokinetic study. Clin Pharmacokinet 2014;54(2):167-78
  • Sadhasivam S, Chidambaran V. Pharmacogenomics of opioids and perioperative pain management. Pharmacogenomics 2012;13(15):1719-40
  • Cohen M, Sadhasivam S, Vinks AA. Pharmacogenetics in perioperative medicine. Curr Opin Anaesthesiol 2012;25(4):419-27
  • Naguib M, Bie B, Ting AH. Fundamental concepts of epigenetics for consideration in anesthesiology. Curr Opin Anaesthesiol 2012;25(4):434-43
  • Chidambaran V, Ngamprasertwong P, Vinks AA, et al. Pharmacogenetics and anesthetic drugs. Curr Clin Pharmacol 2012;7(2):78-101
  • Fernandez Robles CR, Degnan M, Candiotti KA. Pain and genetics. Curr Opin Anaesthesiol 2012;25(4):444-9
  • Comer SD, Cooper ZD, Kowalczyk WJ, et al. Evaluation of potential sex differences in the subjective and analgesic effects of morphine in normal, healthy volunteers. Psychopharmacology (Berl) 2010;208(1):45-55
  • Djurendic-Brenesel M, Mimica-Dukic N, Pilija V, et al. Gender-related differences in the pharmacokinetics of opiates. Forensic Sci Int 2010;194(1-3):28-33
  • Schmitz AK, Vierhaus M, Lohaus A. Pain tolerance in children and adolescents: sex differences and psychosocial influences on pain threshold and endurance. Eur J Pain 2013;17(1):124-31
  • Rabbitts JA, Groenewald CB, Dietz NM, et al. Perioperative opioid requirements are decreased in hypoxic children living at altitude. Pediatr Anesth 2010;20(12):1078-83
  • Rabbitts JA, Groenewald CB, Rasanen J. Geographic differences in perioperative opioid administration in children. Pediatr Anesth 2012;22(7):676-81
  • Jimenez N, Anderson GD, Shen DD, et al. Is ethnicity associated with morphine’s side effects in children? Morphine pharmacokinetics, analgesic response, and side effects in children having tonsillectomy. Pediatr Anesth 2012;22(7):669-75
  • Sadhasivam S, Chidambaran V, Ngamprasertwong P, et al. Race and unequal burden of perioperative pain and opioid related adverse effects in children. Pediatrics 2012;129(5):832-8
  • Sadhasivam S, Krekels EH, Chidambaran V, et al. Morphine clearance in children: does race or genetics matter? J Opioid Manag 2012;8(4):217-26
  • Rigby-Jones A, Sneyd JR. Cardiovascular changes after achieving constant effect site concentration of propofol. Anaesthesia 2008;63(7):780
  • Hutchinson MR, Coats BD, Lewis SS, et al. Proinflammatory cytokines oppose opioid-induced acute and chronic analgesia. Brain Behav Immun 2008;22(8):1178-89
  • Candiotti KA, Yang Z, Morris R, et al. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology 2011;114(5):1162-8
  • Lotsch J, Geisslinger G. Relevance of frequent mu-opioid receptor polymorphisms for opioid activity in healthy volunteers. Pharmacogenomics J 2006;6(3):200-10
  • Walter C, Lotsch J. Meta-analysis of the relevance of the OPRM1 118A>G genetic variant for pain treatment. Pain 2009;146(3):270-5
  • Ross JR, Rutter D, Welsh K, et al. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J 2005;5(5):324-36
  • Liem EB, Joiner TV, Tsueda K, et al. Increased sensitivity to thermal pain and reduced subcutaneous lidocaine efficacy in redheads. Anesthesiology 2005;102(3):509-14
  • Lotsch J, Geisslinger G. Pharmacogenetics of new analgesics. Br J Pharmacol 2011;163(3):447-60
  • Tournier N, Decleves X, Saubamea B, et al. Opioid transport by ATP-binding cassette transporters at the blood-brain barrier: implications for neuropsychopharmacology. Curr Pharm Des 2011;17(26):2829-42
  • Holford NH, Buclin T. Safe and effective variability-a criterion for dose individualization. Ther Drug Monit 2012;34(5):565-8
  • Palomaki GE, Bradley LA, Douglas MP, et al. Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? An evidence-based review. Genet Med 2009;11(1):21-34
  • Li H, Mandema J, Wada R, et al. Modeling the onset and offset of dental pain relief by ibuprofen. J Clin Pharmacol 2012;52(1):89-101
  • Mandema JW, Stanski DR. Population pharmacodynamic model for ketorolac analgesia. Clin Pharmacol Ther 1996;60(6):619-35
  • Hannam JA, Anderson BJ, Mahadevan M, Holford NH. Postoperative analgesia using diclofenac and acetaminophen in children. Paediatr Anaesth 2014;9:953-61
  • Anderson BJ, Holford NH. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet 2009;24(1):25-36

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