1. Efficacy and safety of multiple doses of tapentadol oral solution in the treatment of moderate to severe acute pain in children aged 2 to
- Author
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Beuter C, Volkers G, Radic T, Goldberg J, and van den Anker J
- Subjects
tapentadol oral solution ,pediatric pain management ,moderate to severe acute pain ,efficacy ,safety ,Medicine (General) ,R5-920 - Abstract
Christoph Beuter,1 Gisela Volkers,1 Tatjana Radic,1 Jutta Goldberg,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, USACorrespondence: Christoph Beuter Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, GermanyTel +49 241 569 0Email Christoph.Beuter@grunenthal.comBackground: Well-controlled trials of analgesics in the pediatric population are scarce. Tapentadol is a strong centrally acting analgesic which has undergone a pediatric development program investigating its suitability for treating moderate to severe acute pain across the entire pediatric age range from birth to adolescence. Here, we report data from a pivotal Phase III trial performed as part of this development program.Patients and methods: This randomized, double-blind, placebo-controlled, multicenter clinical trial investigated efficacy and safety/tolerability of multiple tapentadol oral solution doses (OS; target dose 1.25 mg/kg) in the treatment of postsurgical acute pain. Data for patients aged 2 to
- Published
- 2019