The challenge of developing pain medications for children: therapeutic needs and future perspectives.
Pediatric Investigation Plan
acute pain
pain relief
pediatric patients
tapentadol
Journal
Journal of pain research
ISSN: 1178-7090
Titre abrégé: J Pain Res
Pays: New Zealand
ID NLM: 101540514
Informations de publication
Date de publication:
2019
2019
Historique:
received:
23
11
2018
accepted:
27
02
2019
entrez:
20
6
2019
pubmed:
20
6
2019
medline:
20
6
2019
Statut:
epublish
Résumé
It is broadly accepted that children of all age groups including (preterm) neonates and young infants can perceive pain and that there is an absolute need to treat their pain safely and effectively. The approved treatment options for children, particularly (preterm) neonates and young infants, are very limited with only a few medications specifically labelled for this population. This article presents the challenges of developing pain medications for children. A short overview gives information on pain in children, including pain perception, prevalence of pain and the long-term consequences of leaving pain untreated in this vulnerable population. Current pain management practices are briefly discussed. The challenges of conducting pediatric clinical trials in general and trials involving analgesic medications in particular within the regulatory framework available to develop these medications for children are presented. Emphasis is given to the operational hurdles faced in conducting a pediatric clinical trial program. Some suggestions to overcome these hurdles are provided based on our experience during the pediatric trial program for the strong analgesic tapentadol used for the treatment of moderate to severe acute pain.
Identifiants
pubmed: 31213880
doi: 10.2147/JPR.S195788
pii: 195788
pmc: PMC6536714
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1649-1664Déclaration de conflit d'intérêts
Mariëlle Eerdekens, Christoph Beuter, and Claudia Lefeber are employees of Grünenthal GmbH. They report personal fees from Grünenthal GmbH, outside the submitted work. John van den Anker is a paid consultant for Grünenthal. The authors report no other conflicts of interest in this work.
Références
Pain. 1993 Mar;52(3):287-299
pubmed: 8460047
Nat Clin Pract Neurol. 2009 Jan;5(1):35-50
pubmed: 19129789
J Pain. 2009 May;10(5):447-85
pubmed: 19411059
Pediatr Res. 2014 May;75(5):584-7
pubmed: 24500615
Pain. 2001 Aug;93(2):173-183
pubmed: 11427329
Clin Pharmacokinet. 2006;45(7):683-704
pubmed: 16802850
Sci Rep. 2017 May 22;7(1):2215
pubmed: 28533557
Pediatr Nurs. 1997 May-Jun;23(3):293-7
pubmed: 9220806
Cochrane Database Syst Rev. 2015 Dec 02;(12):CD006275
pubmed: 26630545
J Clin Pharmacol. 2018 Oct;58 Suppl 10:S10-S25
pubmed: 30248190
J Neurosci. 2018 Jan 24;38(4):878-886
pubmed: 29255007
N Engl J Med. 1987 Nov 19;317(21):1321-9
pubmed: 3317037
Pediatr Res. 2015 Oct;78(4):417-21
pubmed: 26086643
Pain. 2006 Dec 5;125(3):278-285
pubmed: 17011707
Eur J Pain. 2010 Mar;14(3):321-6
pubmed: 19481484
J Physiol. 2008 Mar 15;586(6):1529-37
pubmed: 18079159
Paediatr Anaesth. 2012 Jul;22 Suppl 1:1-79
pubmed: 22817132
CNS Drugs. 2014 Apr;28(4):319-29
pubmed: 24578192
CMAJ. 2010 Dec 14;182(18):E843-55
pubmed: 21098062
CMAJ. 2017 Feb 13;189(6):E227-E234
pubmed: 27956393
Paediatr Anaesth. 2018 Feb;28(2):186-187
pubmed: 29345086
Acta Paediatr. 2009 Jun;98(6):932-9
pubmed: 19484828
PLoS One. 2015 Apr 13;10(4):e0122918
pubmed: 25875821
J Clin Pharmacol. 2012 Oct;52(10):1601-6
pubmed: 22162537
Adv Ther. 2018 Oct;35(10):1471-1484
pubmed: 30206823
Paediatr Anaesth. 2017 Sep;27(9):893-904
pubmed: 28707454
Paediatr Anaesth. 2017 Dec;27(12):1193-1201
pubmed: 29024184
Pain Manag. 2014 Jan;4(1):57-67
pubmed: 24641344
Pain. 2015 Feb;156(2):222-230
pubmed: 25599443
Exp Physiol. 2015 Dec;100(12):1451-7
pubmed: 26446174
Acad Emerg Med. 2014 Dec;21(12):1421-30
pubmed: 25422152
Pain Manag Nurs. 2014 Mar;15(1):22-35
pubmed: 24602421
JAMA. 2013 Jan 9;309(2):149-54
pubmed: 23299606
Expert Rev Clin Pharmacol. 2017 Jan;10(1):111-126
pubmed: 27785937
Eur J Pain. 2005 Apr;9(2):105-8
pubmed: 15737795
J Pediatr. 2015 Aug;167(2):292-8.e1
pubmed: 25987534
Anesthesiology. 2015 Jan;122(1):150-171
pubmed: 25222831
Ann Rheum Dis. 1977 Apr;36(2):186-7
pubmed: 856067
Pain. 2009 May;143(1-2):138-46
pubmed: 19307058
Anesthesiology. 2012 Feb;116(2):248-73
pubmed: 22227789
Pain. 1993 Feb;52(2):201-208
pubmed: 8455968
Ther Drug Monit. 2014 Dec;36(6):699-705
pubmed: 24819966
J Pediatr Surg. 2011 Sep;46(9):1700-5
pubmed: 21929977
J Pediatr. 2016 Jan;168:13-15
pubmed: 26490127
Paediatr Anaesth. 2013 Jun;23(6):475-95
pubmed: 23570544
J Pain. 2016 Feb;17(2):131-57
pubmed: 26827847
Br J Pharmacol. 2007 Aug;151(8):1334-42
pubmed: 17533423
Intensive Care Med. 2003 Nov;29(11):2009-15
pubmed: 12897995
J Pediatr Surg. 2007 Aug;42(8):1403-8
pubmed: 17706504
Clin Ther. 2005 Jun;27(6):814-43
pubmed: 16117988
Pain. 2013 Oct;154(10):1946-1952
pubmed: 23711638
Eur J Pain. 2009 Feb;13(2):209-13
pubmed: 18479952
Methods Find Exp Clin Pharmacol. 2010 Jan-Feb;32(1):31-8
pubmed: 20383344
J Paediatr Child Health. 2010 Apr;46(4):184-92
pubmed: 20105248
Ann Neurol. 2011 Oct;70(4):541-9
pubmed: 21976396
Pain Rep. 2017 Aug 21;2(5):e616
pubmed: 29392231
Nat Rev Neurosci. 2005 Jul;6(7):507-20
pubmed: 15995722
Lancet. 1995 Feb 4;345(8945):291-2
pubmed: 7837863
J Neurosci. 2006 Apr 5;26(14):3662-6
pubmed: 16597720
Aust Crit Care. 2019 Jan;32(1):4-10
pubmed: 29779912
J Pain. 2008 Sep;9(9):771-83
pubmed: 18562251
Pain. 2012 Jul;153(7):1374-1381
pubmed: 22704600
AJNR Am J Neuroradiol. 2000 Jun-Jul;21(6):1099-109
pubmed: 10871022
Pediatrics. 2006 Nov;118(5):2231-41
pubmed: 17079598
Pain. 2017 May;158(5):794-801
pubmed: 28151835
Psychoneuroendocrinology. 2015 Jan;51:151-63
pubmed: 25313535
J Physiol. 2009 Jun 15;587(Pt 12):2927-35
pubmed: 19403624
N Engl J Med. 1992 Jan 2;326(1):1-9
pubmed: 1530752
Pediatrics. 2014 Mar;133(3):412-21
pubmed: 24534406
Brain Res Dev Brain Res. 1990 Apr 1;53(1):97-102
pubmed: 2161716
PLoS One. 2013 Oct 18;8(10):e76702
pubmed: 24204657
Pain. 2009 Jul;144(1-2):43-8
pubmed: 19329255
Eur J Pain. 2014 Jul;18(6):844-52
pubmed: 24318537
Anesth Analg. 2010 May 1;110(5):1393-8
pubmed: 20418301
Pediatrics. 2001 Sep;108(3):793-7
pubmed: 11533354
Pain. 2009 Jan;141(1-2):79-87
pubmed: 19026489
Arch Dis Child. 2016 Nov;101(11):1017-1025
pubmed: 27226526
Bioanalysis. 2011 Apr;3(7):779-86
pubmed: 21452994
Ann Neurol. 2012 Mar;71(3):385-96
pubmed: 22374882
CMAJ. 2011 Apr 19;183(7):E403-10
pubmed: 21464171
Pain. 2005 Feb;113(3):293-300
pubmed: 15661436
Eur J Pain. 2017 Aug;21(7):1252-1265
pubmed: 28346762
Methods Mol Biol. 2017;1641:25-67
pubmed: 28748457
Clin J Pain. 1996 Mar;12(1):13-22
pubmed: 8722730
Pain. 2018 Feb;159(2):193-205
pubmed: 29140927
Pediatr Neurol. 2013 Feb;48(2):123-129.e1
pubmed: 23337005
Int J Clin Pharmacol Ther. 2013 Apr;51(4):338-48
pubmed: 23357834
Cochrane Database Syst Rev. 2017 Feb 16;2:CD008435
pubmed: 28205208
J Pain Res. 2013;6:167-80
pubmed: 23503375
Pediatrics. 2012 Feb;129(2):354-64
pubmed: 22250028
Pain Res Manag. 2013 Jan-Feb;18(1):47-50
pubmed: 23457686
Eur J Pain. 2007 Aug;11(6):694-9
pubmed: 17185016
J Pain. 2012 Sep;13(9):857-65
pubmed: 22958873
Pain Manag. 2018 Mar;8(2):139-153
pubmed: 29468928
Br J Anaesth. 2010 Jan;104(1):75-9
pubmed: 19915188
Gac Sanit. 2019 May - Jun;33(3):272-282
pubmed: 29452750
Pediatrics. 2014 Aug;134(2):e512-8
pubmed: 25022732
Pain. 2014 Mar;155(3):441-456
pubmed: 24012952
Brain Res Dev Brain Res. 1998 Jun 15;108(1-2):239-54
pubmed: 9693800
J Pediatr. 2018 Jul;198:10-11
pubmed: 29605390
Pediatrics. 2014 Aug;134(2):361-72
pubmed: 25022739
J Pediatr Nurs. 2018 Sep - Oct;42:e85-e90
pubmed: 29681431
Pediatrics. 2004 Jul;114(1):e77-84
pubmed: 15231977
Can J Psychiatry. 2015 Apr;60(4):176-80
pubmed: 26174217
Pain. 2013 Sep;154(9):1831-1839
pubmed: 23748079
Brain Res Dev Brain Res. 1998 Aug 8;109(2):187-99
pubmed: 9729374
Clinics (Sao Paulo). 2012 Oct;67(10):1165-70
pubmed: 23070343
J Pediatr Psychol. 2018 Apr 1;43(3):224-233
pubmed: 29145589
Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80
pubmed: 11177093