ArticleJournal of pain research2019
First evaluation of tapentadol oral solution for the treatment of moderate to severe acute pain in children aged 6 to <18.
Article in Journal of pain research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 20 citations in OpenAlex.
- Review
- The Pharmacological Treatment of Neuropathic Pain in Children.Current neuropharmacology · 2024Review
- Multiple Dose Pharmacokinetics of Tapentadol Oral Solution for the Treatment of Moderate to Severe Acute Pain in Children Aged 2 to <7 Years.Journal of pain research · 2022Article
- Tapentadol for the Treatment of Moderate-to-Severe Acute Pain in Children Under the Age of Two Years.Journal of pain research · 2021Article
- Analgesic Drug Development for Children: A History of Shortcomings … Until Now.Journal of pain research · 2021Article
- Outcomes of the Pediatric Development Plan of Tapentadol.Journal of pain research · 2021Review
- Review
- Diagnosis and Treatment of Chronic Neuropathic and Mixed Pain in Children and Adolescents: Results of a Survey Study amongst Practitioners.Children (Basel, Switzerland) · 2020Article
- Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children.Journal of pain research · 2020Article
- Population Pharmacokinetics of Tapentadol in Children from Birth to <18 Years Old.Journal of pain research · 2020Article
- Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients.Journal of pain research · 2019Article
- Efficacy and safety of multiple doses of tapentadol oral solution in the treatment of moderate to severe acute pain in children aged 2 to <18 years - a randomized, double-blind, placebo-controlled trial.Journal of pain research · 2019Article
- Population pharmacokinetic modeling to facilitate dose selection of tapentadol in the pediatric population.Journal of pain research · 2019Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis is the first clinical trial in the global pediatric clinical development program for the use of the analgesic tapentadol in children and adolescents. PATIENTS AND
methodsThis multicenter, open-label clinical trial investigated pharmacokinetics, safety and tolerability, and efficacy of tapentadol and its major metabolite tapentadol-O-glucuronide after administration of a single dose of tapentadol oral solution (OS) in pediatric patients aged 6 to <18 years experiencing moderate to severe acute pain after surgery. Efficacy (change in pain intensity after tapentadol intake) was assessed in an exploratory manner using the McGrath Color Analog Scale and Faces Pain Scale-Revised. Adverse events were monitored throughout the trial.
resultsForty-four patients who received a single dose of 1 mg/kg tapentadol OS were included in this investigation. Maximum serum concentrations of tapentadol (111 ng/mL) and tapentadol-O-glucuronide (2,400 ng/mL) observed in this trial were within the range of individual maximum concentrations observed in healthy adults administered a comparable dose (range for tapentadol 23.2-129 ng/mL, for tapentadol-O-glucuronide 1,040-4,070 ng/mL). Following tapentadol administration, pain intensity scores improved from baseline at all timepoints. Treatment-emergent adverse events, none of which were serious, were experienced by 45.5% of the patients; the most commonly reported were vomiting (29.5%) and nausea (9.1%).
conclusionsTapentadol OS administered as a single dose of 1 mg/kg in children aged 6 to <18 years was generally well tolerated and produced similar serum concentrations as administration of 50-100 mg tapentadol immediate-release tablets in adults. A decrease in postsurgical pain was observed using exploratory subject-reported pain assessments. Tapentadol OS may provide a new treatment option in the management of moderate to severe acute pain in children and adolescents.
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