Population pharmacokinetics of oral diclofenac for acute pain in children

British Journal of Clinical Pharmacology

Volumn 66, Issue 6, 2008, Pages 846-853

  Standing, Joseph F ^a,b,e   Howard, Richard F ^a,c   Johnson, Atholl ^d   Savage, Imogen ^b   Wong, Ian C K ^a,b,c  

^a GREAT ORMOND STREET HOSPITAL   (United Kingdom)

^b UNIVERSITY OF LONDON   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^e UPPSALA UNIVERSITY   (Sweden)

Author keywords

Acute pain; Children; Diclofenac; NONMEM; Population pharmacokinetics

Indexed keywords

DICLOFENAC; KETOPROFEN; MIDAZOLAM; PARACETAMOL;

ADULT; ALLOMETRY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CHILD; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MAJOR CLINICAL STUDY; MALE; MASS SPECTROMETRY; PAIN; PEDIATRIC SURGERY; PHARMACOKINETICS; POPULATION MODEL; POPULATION PHARMACOKINETICS; PREDICTION; PREOPERATIVE PERIOD; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SIMULATION; SINGLE DRUG DOSE; SUSPENSION; UNSPECIFIED SIDE EFFECT; VOLUNTEER;

ADMINISTRATION, ORAL; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; DICLOFENAC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFANT; MALE; MODELS, BIOLOGICAL; PAIN, POSTOPERATIVE; SUSPENSIONS; TREATMENT OUTCOME;

EID: 56549122658     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2008.03289.x     Document Type: Article

References (28)

1. Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998 316 : 343 5.
2. Tay CLM, Tan S. Diclofenac or paracetamol for analgesia in paediatric myringotomy outpatients. Anaesth Intensive Care 2002 30 : 55 9.
3. McGowan PR, May H, Molnar Z, Cunliffe M. A comparison of three methods of analgesia in children having day case circumscision. Paediatr Anaesth 1998 8 : 403 7.
4. Eustace N, O'Hare B. Use of non-steroidal anti-inflammatory drugs in infants. A survey of members of the Association of Paediatric Anaesthetists of Great Britain and Ireland. Paediatr Anaesth 2007 17 : 464 9.
5. McQuay HJ, Moore RA. Postoperative analgesia and vomiting, with special reference to day-case surgery: a systematic review. Health Technol Assess 1998 2 : 1 236. Winchester, UK. Available at http://www.jr2.ox.ac.uk/bandolier/ painres/download/acuteHTA.pdf (last accessed 1 August 2008).
6. Lau HSH, Chan K, Shum L, Adair S, Ross H, Eyring H, Gause D, John V. Dose proportionality of diclofenac sodium (Voltaren) in man. (conference abstract). Pharmaceutical Res 1989 6 : S194.
7. Morita I. Distinct functions of COX-1 and COX-2. Prostaglandins Other Lipid Mediat 2002 68 69 : 165 75.
8. Blobaum AL, Marnett LJ. Molecular determinants for the selective inhibition of cyclo-oxygenase-2 by lumiracoxib. J Biol Chem 2007 282 : 16379 90.
9. Rowlinson SW, Kiefer JR, Prusakiewicz JJ, Pawlitz JL, Kozak KR, Kalgutkar AS, Stallings WC, Kurumbail RG, Marnett LJ. A novel mechanism of cyclo-oxygenase-2 inhibition involving interactions with Ser-530 and Tyr-385. J Biol Chem 2003 46 : 45763 9.
10. Burian M, Tegeder I, Seegel M, Geisslinger G. Peripheral and central antihyperalgesic effects of diclofenac in a model of human inflammatory pain. Clin Pharmacol Ther 2003 74 : 113 20.
11. von Bayer C, Spagrud L. Systematic review of observational (behavioural) measures of pain in children and adolescents aged 3 to 18 years. Pain 2007 127 : 140 50.
12. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000 356 : 1255 9.
13. Beal SL, Sheiner LB, Boeckmann AJ, eds. NONMEM User Guides. Ellicott City, MD : Icon Development Solutions, 2006.
14. Savic RM, Jonker DM, Kerbusch T, Karlsson MO. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn 2007 34 : 711 26.
15. Meibohm B, Laer S, Pancetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J 2005 7 : E475 87.
16. Anderson BJ, Holford NHG. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008 48 : 12.1 12.30.
17. Karlsson MO, Sheiner LB. The importance of modelling interocassion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993 21 : 735 50.
18. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther 2007 82 : 17 20.
19. Pharsight. WinNonlin Reference Guide. Mountain View, CA : Pharsight, 2005.
20. van der Marel CD, Anderson BJ, Romsing J, Jacqz-Aigrain E, Tibboel D. Diclofenac and metabolite pharmacokinetics in children. Paediatr Anaesth 2004 14 : 443 51.
21. Macia MA, Frias J, Carcas AJ, Guerra P, Valiente R, Lucero ML. Comparative bioavailability of a dispersible formulation of diclofenac and finding of double plasma peaks. Int J Clin Pharmacol Ther 1995 33 : 333 9.
22. Lotsch J, Kettenmann B, Renner B, Drover D, Brune K, Geisslinger G, Kobal G. Population pharmacokinetics of fast release oral diclofenac in healthy volunteers: relation to pharmacodynamics in an experimental pain model. Pharmaceutical Res 2000 17 : 77 84.
23. Idkaidek NM, Amidon GL, Smith DE, Najib NM, Hassan MM. Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting using NONMEM. Biopharm Drug Dispos 1998 19 : 169 74.
24. Lund W, ed. The Pharmaceutical Codex: Principles and Practice of Pharmaceutics, 12th edn. London : Royal Pharmaceutical Society of Great Britain, 1993.
25. Davies NM, Anderson KE. Clinical pharmacokinetics of diclofenac. Clin Pharmacokinet 1997 33 : 184 213.
26. Korpela R, Olkkola KT. Pharmacokinetics of intravenous diclofenac sodium in children. Eur J Clin Pharmacol 1990 38 : 293 5.
27. Kleiber M. Body size and metabolic rate. Physiol Rev 1947 27 : 511 41.
28. Johnson TN, Tucker GT, Tanner MS, Rostami-Hodjegan A. Changes in liver volume from birth to adulthood: a meta-analysis. Liver Transpl 2005 12 : 1481 93.