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      Tapentadol for the Treatment of Moderate-to-Severe Acute Pain in Children Under the Age of Two Years

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          Pharmacokinetics (PK), efficacy, and safety of the opioid analgesic tapentadol in the treatment of moderate-to-severe acute pain have so far not been investigated in pediatric patients <2 years of age.

          Patients and Methods

          Two multicenter, open-label trials assessed the pharmacokinetic profile, safety, tolerability, and efficacy of single doses of tapentadol oral solution (OS; NCT02221674; n=19) or intravenous infusion (IV, EudraCT 2014-002259-24; n=38) in children from birth to <2 years of age. Of these, 8 preterm neonates were included in the IV trial. A third randomized, double-blind, placebo-controlled trial (NCT02081391) investigated the efficacy and safety of multiple tapentadol OS doses in patients from birth to <2 years (placebo n=4, tapentadol n=11) using an immediate rescue trial design. Patients in all three trials underwent surgery that, in the investigator’s opinion, reliably produced moderate-to-severe pain requiring opioid treatment.


          Administration of single tapentadol doses resulted in tapentadol serum concentrations within the targeted range known to be safe and efficacious in adults and compared well to the range observed for children aged 2 to <18 years. Pain intensity already improved 15 min after administration. In the multiple dose trial, amounts of supplemental opioid analgesic medication within the first 24 h after start of trial medication were low (placebo 0.02 mg/kg, tapentadol 0.05 mg/kg). All patients stopped treatment with the trial medication because opioid analgesics were no longer required. Treatment-emergent adverse events occurred in 42.1% (tapentadol OS single dose), 28.9% (tapentadol IV), and 75% of placebo and 54.5% of tapentadol patients (tapentadol OS multiple doses), none of them serious.


          Tapentadol showed a favorable PK and safety profile in children <2 years of age. Multiple tapentadol OS dosing is efficacious and generally well tolerated in children ≥2 years and might also be a useful treatment option for children <2 years in need of strong analgesics.

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          Most cited references 32

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

          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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            The assessment and management of acute pain in infants, children, and adolescents.

            Acute pain is one of the most common adverse stimuli experienced by children, occurring as a result of injury, illness, and necessary medical procedures. It is associated with increased anxiety, avoidance, somatic symptoms, and increased parent distress. Despite the magnitude of effects that acute pain can have on a child, it is often inadequately assessed and treated. Numerous myths, insufficient knowledge among caregivers, and inadequate application of knowledge contribute to the lack of effective management. The pediatric acute pain experience involves the interaction of physiologic, psychologic, behavioral, developmental, and situational factors. Pain is an inherently subjective multifactorial experience and should be assessed and treated as such. Pediatricians are responsible for eliminating or assuaging pain and suffering in children when possible. To accomplish this, pediatricians need to expand their knowledge, use appropriate assessment tools and techniques, anticipate painful experiences and intervene accordingly, use a multimodal approach to pain management, use a multidisciplinary approach when possible, involve families, and advocate for the use of effective pain management in children.
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              Prevention and management of pain in the neonate: an update.

               ,  K Barrington,   (2006)
              The prevention of pain in neonates should be the goal of all caregivers, because repeated painful exposures have the potential for deleterious consequences. Neonates at greatest risk of neurodevelopmental impairment as a result of preterm birth (ie, the smallest and sickest) are also those most likely to be exposed to the greatest number of painful stimuli in the NICU. Although there are major gaps in our knowledge regarding the most effective way to prevent and relieve pain in neonates, proven and safe therapies are currently underused for routine minor yet painful procedures. Every health care facility caring for neonates should implement an effective pain-prevention program, which includes strategies for routinely assessing pain, minimizing the number of painful procedures performed, effectively using pharmacologic and nonpharmacologic therapies for the prevention of pain associated with routine minor procedures, and eliminating pain associated with surgery and other major procedures.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                29 January 2021
                : 14
                : 229-248
                [1 ]Anaesthetic Department, Sheffield Children’s Hospital, Western Bank , Sheffield, UK
                [2 ]Grünenthal USA Inc ., Overland Park, KS, USA
                [3 ]Grünenthal GmbH , Aachen, Germany
                [4 ]Department of Pediatrics and Anesthesiology, Perioperative and Pain Management, Stanford University School of Medicine , Stanford, CA, USA
                Author notes
                Correspondence: Christoph Beuter Grünenthal GmbH , Zieglerstraße 6, 52078 Aachen, GermanyTel +49 241 569 0 Email Christoph.Beuter@grunenthal.com
                © 2021 Eissa et al.

                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).

                Page count
                Figures: 5, Tables: 16, References: 37, Pages: 20
                Original Research


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