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Efficacy and safety of multiple doses of tapentadol oral solution in the treatment of moderate to severe acute pain in children aged 2 to <18 years – a randomized, double-blind, placebo-controlled trial

Authors Beuter C, Volkers G, Radic T, Goldberg J, van den Anker J

Received 27 February 2019

Accepted for publication 30 September 2019

Published 13 November 2019 Volume 2019:12 Pages 3099—3112


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Michael A Überall

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, USA

Correspondence: Christoph Beuter Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
Tel +49 241 569 0

Background: 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 <18 years are reported here. The main objective of the trial was to investigate if oral tapentadol administration compared to placebo reduces the use of supplemental opioid analgesic medication within the first 24 hrs of treatment. Other investigated parameters included taste and palatability of the trial medication, adverse events (AEs), vital signs, and laboratory parameters.
Results: A total of 160 patients were included (placebo n=52, tapentadol n=108). It was shown that the total amount of supplemental opioid analgesic medication used in the first 24 hrs was significantly lower in tapentadol patients than placebo patients (p=0.0154). Taste and palatability of tapentadol OS was well perceived by most patients. Treatment-emergent AEs were reported in 50% of patients treated with placebo vs 57.4% in those exposed to tapentadol, most commonly vomiting, nausea, and constipation in both treatment groups.
Conclusion: Tapentadol OS was effective and generally well tolerated in children (≥2 years) for the treatment of moderate to severe acute pain. Across all age groups, palatability and acceptability of tapentadol OS were sufficient to ensure intake compliance. This trial provides evidence that tapentadol OS can be effectively used to treat pain in young patients for whom currently limited labelled treatment options are available.

Keywords: tapentadol oral solution, pediatric pain management, moderate to severe acute pain, efficacy, safety

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