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      Journal of Pain Research (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of high-quality laboratory and clinical findings in all fields of pain research and the prevention and management of pain. Sign up for email alerts here.

      52,235 Monthly downloads/views I 2.832 Impact Factor I 4.5 CiteScore I 1.2 Source Normalized Impact per Paper (SNIP) I 0.655 Scimago Journal & Country Rank (SJR)

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      Outcomes of the Pediatric Development Plan of Tapentadol

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          Abstract

          The opioid analgesic tapentadol was the first pain medication to be developed for the treatment of pain in children under a formal process established by the regulatory authorities. This article summarizes the outcomes of the pediatric development program for tapentadol across the entire age range from birth (including neonates) to adolescents <18 years of age. In addition, the challenges experienced when designing and conducting the pediatric tapentadol clinical trials as well as the interactions with the regulatory authorities are discussed. As a first outcome, the oral solution of tapentadol was authorized in the EU in 2018 as a new treatment option in the hospital setting for moderate to severe acute pain in children from 2 to <18 years of age.

          Most cited references26

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          Opioid Therapy in Acute and Chronic Pain

          Anne Nafziger, Robert Barkin (2018)
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            Comparison Between Effect of Lidocaine, Morphine and Ketamine Spray on Post-Tonsillectomy Pain in Children

            Seyed Abbas Hosseini Jahromi, Seyedeh Masoumeh Hosseini Valami, Sevak Hatamian (2012)
            Background An effective pain therapy to block or modify the physiological responses to stress has become an essential component of modern pediatric anesthesia and surgical practice. Objectives The goal of this study was to compare the analgesic effects of the spray forms of; lidocaine, morphine, ketamine, and normal saline on post-tonsillectomy pain scores in children. Patients and Methods A total of 120 children, American Society of Anesthesiologist (ASA) class I–II, scheduled for elective tonsillectomy were enrolled in this double-blind, clinical trial study. They were randomly divided into 4 groups, each receiving one of the following drugs at the end of operation; lidocaine spray (2 mg/kg); morphine spray (0.05 mg/kg); ketamine spray (0.5 mg/kg); or normal saline spray (8 puffs). For comparison of postoperative pain; the face, legs, activity, cry, consolability (FLACC) pain scale was evaluated during the first one hour of recovery period at 20 minutes intervals. The data was transferred to SPSS-10 software and analyzed statistically with the Scheffe test and Dunnett’s T3 test. P value less than 0.05 was considered significant. Results In the early postoperative period (time: 0) and at 20, 40 and 60 minutes of recovery time, FLACC scale scores in the control group were higher than in the three other groups. At 20 minutes, the FLACC scale score in the lidocaine group was lower than in the other groups. At 40 minutes, the statistical differences between FLACC scales of the lidocaine, morphine and ketamine groups were not significant (P > 0.05). Finally, at 60 minutes, the FLACC scale scores of the ketamine and morphine groups were lower than in the other groups. Conclusions The results of this study showed that lidocaine spray had the best pain controlling effect at 20 minutes in the recovery room, but after 40 minutes, ketamine and morphine sprays were more effective than the lidocaine spray.
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              Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop.

              Lynne G Maxwell, Bonnie Stevens, Gary A Walco … (2012)
              Analgesic trials pose unique scientific, ethical, and practical challenges in pediatrics. Participants in a scientific workshop sponsored by the US Food and Drug Administration developed consensus on aspects of pediatric analgesic clinical trial design. The standard parallel-placebo analgesic trial design commonly used for adults has ethical and practical difficulties in pediatrics, due to the likelihood of subjects experiencing pain for extended periods of time. Immediate-rescue designs using opioid-sparing, rather than pain scores, as a primary outcome measure have been successfully used in pediatric analgesic efficacy trials. These designs maintain some of the scientific benefits of blinding, with some ethical and practical advantages over traditional designs. Preferred outcome measures were recommended for each age group. Acute pain trials are feasible for children undergoing surgery. Pharmacodynamic responses to opioids, local anesthetics, acetaminophen, and nonsteroidal antiinflammatory drugs appear substantially mature by age 2 years. There is currently no clear evidence for analgesic efficacy of acetaminophen or nonsteroidal antiinflammatory drugs in neonates or infants younger than 3 months of age. Small sample designs, including cross-over trials and N of 1 trials, for particular pediatric chronic pain conditions and for studies of pain and irritability in pediatric palliative care should be considered. Pediatric analgesic trials can be improved by using innovative study designs and outcome measures specific for children. Multicenter consortia will help to facilitate adequately powered pediatric analgesic trials.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Pain Res
                Journal ID (iso-abbrev): J Pain Res
                Journal ID (publisher-id): jpr
                Journal ID (pmc): jpainres
                Title: Journal of Pain Research
                Publisher: Dove
                ISSN (Electronic): 1178-7090
                Publication date (Electronic): 29 January 2021
                Publication date Collection: 2021
                Volume: 14
                Pages: 249-261
                Affiliations
                [1 ]Grünenthal GmbH , Aachen, Germany
                Author notes
                Correspondence: Mariëlle Eerdekens Grünenthal GmbH , Zieglerstraße 6, 52078 Aachen, GermanyTel +49 241 569 1090 Email marielle.eerdekens@grunenthal.com
                Author information
                http://orcid.org/0000-0001-6198-4806
                http://orcid.org/0000-0002-4042-4567
                http://orcid.org/0000-0003-4419-4727
                http://orcid.org/0000-0002-1724-2909
                http://orcid.org/0000-0003-4939-4306
                Article
                Publisher ID: 290487
                DOI: 10.2147/JPR.S290487
                PMC ID: 7853428
                PubMed ID: 33542654
                SO-VID: 5447c19d-f210-427f-be0c-c79cb93feba2
                Copyright © © 2021 Eerdekens et al.
                License:

                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 ( http://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 ( https://www.dovepress.com/terms.php).

                History
                Date received : 04 November 2020
                Date accepted : 23 December 2020
                Page count
                Figures: 4, Tables: 6, References: 36, Pages: 13
                Categories
                Subject: Review

                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: pain,pediatric,regulations,tapentadol,review
                Data availability:
                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: pain, pediatric, regulations, tapentadol, review

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