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The challenge of developing pain medications for children: therapeutic needs and future perspectives

Authors Eerdekens M, Beuter C, Lefeber C, van den Anker J

Received 23 November 2018

Accepted for publication 27 February 2019

Published 23 May 2019 Volume 2019:12 Pages 1649—1664

DOI https://doi.org/10.2147/JPR.S195788

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Katherine Hanlon


Mariëlle Eerdekens,1 Christoph Beuter,1 Claudia Lefeber,1 John van den Anker2,3

1Grünenthal GmbH, Aachen, Germany; 2Division of Paediatric Pharmacology and Pharmacometrics, University of Basel Children’s Hospital, Basel, Switzerland; 3Division of Clinical Pharmacology, Children’s National Medical Center, Washington, DC, USA

Abstract: 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.

Keywords: pediatric patients, Pediatric Investigation Plan, pain relief, acute pain, tapentadol


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