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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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      Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients

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          Abstract

          Background: This trial is part of the global pediatric clinical development program investigating the administration of the strong analgesic tapentadol in children and adolescents.

          Patients and methods: The single site, open-label phase 2 trial evaluated the pharmacokinetic profile of tapentadol and its major metabolite, tapentadol-O-glucuronide, as well as safety and tolerability and efficacy of a single dose of tapentadol oral solution (1 mg/kg) in patients (2 to <18 years) undergoing dental, ear, nose, or throat surgery. Blood sampling and pain intensity measurements were conducted using age-appropriate schedules and rating scales, respectively. Adverse events were monitored throughout the trial.

          Results: Sixty-six patients were treated. They were stratified by age: Group 1 (12 to <18 years), n=21; Group 2 (6 to <12 years), n=28; and Groups 3 (3 to <6 years) and 4 (2 to <3 years), n=17. Serum tapentadol concentrations observed in these pediatric patients were within the range observed in adults after administration of a single tapentadol immediate-release dose (50–100 mg), whereas those of the metabolite tapentadol-O-glucuronide were within the same range or lower than in adults who received comparable single doses of tapentadol. Pain intensity improved over time across all age groups. The most common treatment-emergent adverse events were nausea (24.2%), vomiting (16.7%), dizziness (9.1%), and headache (6.1%).

          Conclusion: A single dose of tapentadol oral solution (1 mg/kg) administered to pediatric patients (2 to <18 years) resulted in serum tapentadol concentrations within the targeted range shown to be safe and efficacious in adults. Tapentadol demonstrated good tolerability and safety; within the limitations of the trial design, improvements in postsurgical pain intensity were observed across the age groups. Tapentadol may provide a new treatment option in the management of moderate to severe pediatric pain.

          Most cited references21

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          The FLACC: a behavioral scale for scoring postoperative pain in young children.

          S I Merkel, T Voepel-Lewis, J Shayevitz … (1997)
          To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates five categories of pain behaviors: facial expression; leg movement; activity; cry; and consolability. Eighty-nine children aged 2 months to 7 years, (3.0 +/- 2.0 yrs.) who had undergone a variety of surgical procedures, were observed in the Post Anesthesia Care Unit (PACU). The study consisted of: 1) measuring interrater reliability; 2) testing validity by measuring changes in FLACC scores in response to administration of analgesics; and 3) comparing FLACC scores to other pain ratings. The FLACC tool was found to have high interrater reliability. Preliminary evidence of validity was provided by the significant decrease in FLACC scores related to administration of analgesics. Validity was also supported by the correlation with scores assigned by the Objective Pain Scale (OPS) and nurses' global ratings of pain. The FLACC provides a simple framework for quantifying pain behaviors in children who may not be able to verbalize the presence or severity of pain. Our preliminary data indicates the FLACC pain assessment tool is valid and reliable.
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            Effect of neonatal circumcision on pain response during subsequent routine vaccination.

            Anna Taddio, Joel Katz, A. Lane Ilersich … (1997)
            Preliminary studies suggested that pain experienced by infants in the neonatal period may have long-lasting effects on future infant behaviour. The objectives of this study were to find out whether neonatal circumcision altered pain response at 4-month or 6-month vaccination compared with the response in uncircumcised infants, and whether pretreatment of circumcision pain with lidocaine-prilocaine cream (Emla) affects the subsequent vaccination response. We used a prospective cohort design to study 87 infants. The infants formed three groups--uncircumcised infants, and infants who had been randomly assigned Emla or placebo in a previous clinical trial to assess the efficacy of Emla cream as pretreatment for pain in neonatal circumcision. Infants were videotaped during vaccination done at the primary care physician's clinic. Videotapes were scored without knowledge of circumcision or treatment status by a research assistant who had been trained to measure infant facial action, cry duration, and visual analogue scale pain scores. Birth characteristics and infant characteristics at the time of vaccination, including age and temperament scores, did not differ significantly among groups. Multivariate ANOVA revealed a significant group effect (p < 0.001) in difference (vaccination minus baseline) values for percentage facial action, percentage cry time, and visual analogue scale pain scores. Univariate ANOVAs were significant for all outcome measures (p < 0.05): infants circumcised with placebo had higher difference scores than uncircumcised infants for percentage facial action (136.9 vs 77.5%), percentage cry duration (53.8 vs 24.7%), and visual analogue scale pain scores (5.1 vs 3.1 cm). There was a significant linear trend on all outcome measures, showing increasing pain scores from uncircumcised infants, to those circumcised with Emla, to those circumcised with placebo. Circumcised infants showed a stronger pain response to subsequent routine vaccination than uncircumcised infants. Among the circumcised group, preoperative treatment with Emla attenuated the pain response to vaccination. We recommend treatment to prevent neonatal circumcision pain.
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              A new analogue scale for assessing children's pain: an initial validation study.

              Colman McGrath, L. Stitt, Timothy Booth … (1996)
              A new instrument was designed to provide a practical clinical measure for assessing children's pain intensity and pain affect. The pocket size measure includes a Coloured Analogue Scale (CAS) to assess intensity and a facial affective scale to assess the aversive component of pain. Both scales have numerical ratings on the back, so that the person administering it can quickly note the numbers that represent a child's pain. This study was conducted to determine the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales. Since visual analogue scales (VAS) are valid and reliable measures for assessing children's pain, children's ability to use the new analog scale was compared with their performance on a VAS. Children's ability to rate pain affect using an affective scale, in which the 9 faces on a Facial Affective Scale (FAS) are presented in an ordered sequence from least to most distressed, was compared to their performance on the original FAS, in which the same faces were presented in a random order. Using a parallel groups design, 104 children (5-16 years; 60 female, 44 male; 51 healthy and 53 with recurrent headaches) were randomized into two groups: CAS or VAS. Children used the assigned scale to complete a calibration task, in which they rated the sizes of 7 circles varying in area (491, 804, 1385, 2923, 3848, 5675 and 7854 mm2). The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS. Children's CAS and VAS responses on the calibration task yielded similar mathematical relationships: psi cas = 0.035I0.87, psi vas = 0.027I0.89, where psi = perceived magnitude and I = stimulus intensity. The R2 values were 0.921 and 0.922 for the CAS and VAS groups, respectively. Analyses of covariance revealed no significant differences in the characteristics of these relationships, i.e., R2, slope, or y intercept, by scale type. Children used the same scale to complete the Children's Pain Inventory (CPI), in which they rated the intensity and affect of 16 painful events (varying in nature and extent of tissue damage). Children's CAS and VAS responses on the CPI were similar. Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type. However, the mean number of painful events experienced by children increased significantly with age (P = 0.0001). Intensity ratings decreased significantly with age (P = 0.002), but affective ratings did not vary with age. The new instrument has equivalent psychometric properties to a 165 mm VAS. However, the CAS was rated as easier to administer and score than the VAS, so it may be more practical for routine clinical use. Since the CAS has fulfilled the first two criteria for a pain measure (psychophysical properties and discriminant validity), it is ethical to proceed with the formal definitive test for construct validity, in which children from various clinical populations use the CAS scale to assess their own pain.
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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): 31 May 2019
                Publication date Collection: 2019
                Volume: 12
                Pages: 1777-1790
                Affiliations
                [1 ]Jean Brown Research , Salt Lake City, UT, USA
                [2 ]Grünenthal USA Inc ., Overland Park, KS, USA
                [3 ]Grünenthal GmbH , Aachen, Germany
                Author notes
                Correspondence: Eva TarauGrünenthal USA Inc ., 9707 W 145th Ter., Overland Park, KS66221, USATel +1 908 342 1831Email eva.tarau@ 123456grunenthal.com
                Article
                Publisher ID: 197039
                DOI: 10.2147/JPR.S197039
                PMC ID: 6549717
                SO-VID: 059ea9f7-eb33-4376-96d6-8d560fd4e1d6
                Copyright © © 2019 Muse 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 December 2018
                Date accepted : 27 February 2019
                Page count
                Figures: 5, Tables: 7, References: 29, Pages: 14
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: analgesics,pediatric pain management,moderate to severe pain,opioid receptors,tapentadol
                Data availability:
                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: analgesics, pediatric pain management, moderate to severe pain, opioid receptors, tapentadol

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