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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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      Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children

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          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.

          Most cited references32

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          The epidemiology of chronic pain in children and adolescents revisited: a systematic review.

          Sara King, Christine T Chambers, Anna Huguet … (2011)
          Chronic and recurrent pain not associated with a disease is very common in childhood and adolescence, but studies of pain prevalence have yielded inconsistent findings. This systematic review examined studies of chronic and recurrent pain prevalence to provide updated aggregated prevalence rates. The review also examined correlates of chronic and recurrent pain such as age, sex, and psychosocial functioning. Studies of pain prevalence rates in children and adolescents published in English or French between 1991 and 2009 were identified using EMBASE, Medline, CINAHL, and PsycINFO databases. Of 185 published papers yielded by the search, 58 met inclusion criteria and were reviewed, and 41 were included in the review. Two independent reviewers screened papers for inclusion, extracted data, and assessed the quality of studies. Prevalence rates ranged substantially, and were as follows: headache: 8-83%; abdominal pain: 4-53%; back pain: 14-24%; musculoskeletal pain: 4-40%; multiple pains: 4-49%; other pains: 5-88%. Pain prevalence rates were generally higher in girls and increased with age for most pain types. Lower socioeconomic status was associated with higher pain prevalence especially for headache. Most studies did not meet quality criteria. Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
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            The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement.

            P A Spafford, J. Goodenough, William Heymann … (2001)
            The Faces Pain Scale (FPS; Bieri et al., Pain 41 (1990) 139) is a self-report measure used to assess the intensity of children's pain. Three studies were carried out to revise the original scale and validate the adapted version. In the first phase, the FPS was revised from its original seven faces to six, while maintaining its desirable psychometric properties, in order to make it compatible in scoring with other self-rating and observational scales which use a common metric (0-5 or 0-10). Using a computer-animated version of the FPS developed by Champion and colleagues (Sydney Animated Facial Expressions Scale), psychophysical methods were applied to identify four faces representing equal intervals between the scale values representing least pain and most pain. In the second phase, children used the new six-face Faces Pain Scale-Revised (FPS-R) to rate the intensity of pain from ear piercing. Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. In the third phase, a clinical sample of pediatric inpatients aged 4-12 years used the FPS-R and a VAS or the colored analogue scale (CAS) to rate pain during hospitalization for surgical and non-surgical painful conditions. The validity of the FPS-R was further supported by strong positive correlations with the VAS (r=0.92, N=45) and the CAS (r=0.84, N=45) in this clinical sample. Most children in all age groups including the youngest were able to use the FPS-R in a manner that was consistent with the other measures. There were no significant differences between the means on the FPS-R and either of the analogue scales. The FPS-R is shown to be appropriate for use in assessment of the intensity of children's acute pain from age 4 or 5 onward. It has the advantage of being suitable for use with the most widely used metric for scoring (0-10), and conforms closely to a linear interval scale.
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              Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk.

              C. Farrington, G. Manning (1990)
              When it is required to establish a materially significant difference between two treatments, or, alternatively, to show that two treatments are equivalent, standard test statistics and sample size formulae based on a null hypothesis of no difference no longer apply. This paper reviews some of the test statistics and sample size formulae proposed for comparative binomial trials when the null hypothesis is of a specified non-zero difference or non-unity relative risk. Methods based on restricted maximum likelihood estimation are recommended and applied to studies of pertussis vaccine.
              Article 0 comments Cited 133 times – based on 0 reviews     Review now
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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): 30 November 2020
                Publication date Collection: 2020
                Volume: 13
                Pages: 3157-3170
                Affiliations
                [1 ]Department of Anaesthesia and Pain Medicine, Great Ormond Street Hospital and the GOS-UCL Institute of Child Health , London, UK
                [2 ]Grünenthal GmbH , Aachen, Germany
                Author notes
                Correspondence: Richard F HowardDepartment of Anaesthesia and Pain Medicine, Great Ormond Street Hospital and the GOS-UCL Institute of Child Health , LondonWC1N 3JH, UKTel +44 2078298865 Email R.Howard@ucl.ac.uk
                Author information
                http://orcid.org/0000-0002-4042-4567
                http://orcid.org/0000-0001-6198-4806
                http://orcid.org/0000-0001-9461-6890
                Article
                Publisher ID: 272751
                DOI: 10.2147/JPR.S272751
                PMC ID: 7725093
                SO-VID: 6969158c-fe8b-49c8-8359-4470917f9d0e
                Copyright © © 2020 Howard 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 : 21 July 2020
                Date accepted : 27 September 2020
                Page count
                Figures: 4, Tables: 11, References: 34, Pages: 14
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: tapentadol,analgesic,prolonged-release,pain,child,adolescent
                Data availability:
                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: tapentadol, analgesic, prolonged-release, pain, child, adolescent

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