Howard, RF;
Radic, T;
Sohns, M;
Eerdekens, M;
Waßmuth, A;
(2020)
Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children.
Journal of Pain Research
, 13
pp. 3157-3170.
10.2147/JPR.S272751.
Preview |
Text
272751-tapentadol-prolonged-release-for-long-term-treatment-of-pain_64249.pdf - Published Version Download (2MB) | Preview |
Abstract
Purpose: Investigation of the efficacy and safety of tapentadol prolonged release (PR) compared with morphine PR for long-term treatment of pain in children. / Patients and Methods: Children aged 6 to < 18 years requiring long-term treatment with opioids were studied in a 12-month, 2-part, multi-center trial: Part 1, 14-day open-label, randomized, active-controlled, parallel group non-inferiority trial comparing twice daily tapentadol PR with morphine PR; Part 2, open-label treatment with tapentadol PR for up to 12 months or no treatment “safety observation period”. Pain intensity was rated with visual analogue scale or Faces Pain Scale-Revised, and non-inferiority was assessed by comparison of “treatment responders” (those completing the 14-day treatment period and showing pre-defined changes in pain rating) in each group. / Results: Twenty-three of 48 centers enrolled 73 patients. In Part 1, 45 and 24 patients received tapentadol or morphine, respectively, of which 40 and 22 completed 14-day treatment. In Part 2, thirty-six and 58 patients entered the tapentadol PR or observation periods, respectively, with 20/36 completing at least 12 weeks of treatment; 10 of the 36 had received morphine in Part 1. Forty-four of the 58 patients in the safety observation period had received tapentadol. Tapentadol PR was non-inferior to morphine PR (lower limit of confidence interval above negative non-inferiority margin of − 0.2) in Part 1. Rates of adverse events were as expected with nausea (22.2%) and constipation (15.6%) in the tapentadol PR group, and with vomiting (33.3%), nausea and constipation (each 16.7%) in the morphine PR group. No new safety issues were identified; the safety profile of tapentadol over the 12 months treatment and observation periods was comparable to that established in subjects > 18 years old. / Conclusion: Tapentadol PR was well tolerated and equivalent to morphine PR for both efficacy and safety in children (6 to < 18 years old) requiring long-term treatment with opioids.
| Type: | Article |
|---|---|
| Title: | Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.2147/JPR.S272751 |
| Publisher version: | https://doi.org/10.2147/JPR.S272751 |
| Language: | English |
| Additional information: | This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License (https://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms. |
| Keywords: | tapentadol, analgesic, prolonged-release, pain, child, adolescent |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Developmental Neurosciences Dept |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10118145 |
Archive Staff Only
 |
View Item |
