Multiple Dose Pharmacokinetics of Tapentadol Oral Solution for the Treatment of Moderate to Severe Acute Pain in Children Aged 2 to 7 Years

Multiple Dose Pharmacokinetics of Tapentadol Oral Solution for the Treatment of Moderate to Severe Acute Pain in Children Aged 2 to 7 Years

Background: This prospective, open-label trial was conducted to fulfil a post-approval commitment made to the competent authorities to extend the indication of the strong opioid analgesic tapentadol hydrochloride oral solution (OS) to the pediatric population. Patients and Methods: The trial assesse...

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Veröffentlicht in:Journal of pain research 2022-10, Vol.15, p.3103-3114
Hauptverfasser: Jonczyk, Renata, Beuter, Christoph, Bulawa, Beata, Buller, Stefan, Eibl, Christoph, Elling, Christian, Rengelshausen, Jens, Schmidt, Carsten, Thommes, Guido, Khalil, Feras
Format: Artikel
Sprache:eng
Schlagworte:
Acute pain
Age
Analgesics
Care and treatment
Children
Children & youth
Clinical trials
Drug dosages
Gender
Health aspects
Informed consent
Meclofenamate
Metabolites
multiple dosing
Narcotics
Oral medication
Original Research
Pain
Pediatrics
Pharmacokinetics
poppk model tapentadol
Population
Risk assessment
Simulation
Simulation methods
Sulfates
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Zusammenfassung:Background: This prospective, open-label trial was conducted to fulfil a post-approval commitment made to the competent authorities to extend the indication of the strong opioid analgesic tapentadol hydrochloride oral solution (OS) to the pediatric population. Patients and Methods: The trial assessed the pharmacokinetic (PK) profile of tapentadol, tapentadol-O-glucuronide and tapentadol-O-sulfate after administration of multiple doses of tapentadol OS (1.25 mg tapentadol/kg bodyweight every 4 h for up to 72 h) in children aged 2 to
ISSN:1178-7090
1178-7090
DOI:10.2147/JPR.S364902