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. 2019 May 23:12:1649-1664.
doi: 10.2147/JPR.S195788. eCollection 2019.

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

Mariëlle Eerdekens  1 , Christoph Beuter  1 , Claudia Lefeber  1 , John van den Anker  2   3
Affiliations

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

Mariëlle Eerdekens et al. J Pain Res. .

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 Investigation Plan; acute pain; pain relief; pediatric patients; tapentadol.

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Conflict of interest statement

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.

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