Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants

Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants

Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo‐controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate...

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Veröffentlicht in:Journal of clinical pharmacology 2020-01, Vol.60 (1), p.16-27
Hauptverfasser: Hammer, Gregory B., Maxwell, Lynne G., Taicher, Brad M., Visoiu, Mihaela, Cooper, David S., Szmuk, Peter, Pheng, Leng Hong, Gosselin, Nathalie H., Lu, Jia, Devarakonda, Krishna
Format: Artikel
Sprache:eng
Schlagworte:
Acetaminophen
Acetaminophen - administration & dosage
Acetaminophen - adverse effects
Acetaminophen - pharmacokinetics
Acetaminophen - therapeutic use
acute postoperative pain
Adolescents
Analgesics
Analgesics, Non-Narcotic - administration & dosage
Analgesics, Non-Narcotic - adverse effects
Analgesics, Non-Narcotic - pharmacokinetics
Analgesics, Non-Narcotic - therapeutic use
Babies
Blood levels
Continuing Education: Pediatric Pharmacology
Dose-Response Relationship, Drug
Female
Humans
Infant
Infant, Newborn
Infants
Infusions, Intravenous
Intravenous administration
Male
Neonates
Newborn babies
Opioids
Pain
Pain Management
Pain, Postoperative - drug therapy
Pain, Postoperative - metabolism
Patients
Pharmacodynamics
Pharmacokinetics
Postoperative period
Randomization
Rectum
Surgery
Treatment Outcome
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Zusammenfassung:Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo‐controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate and infant patients with acute postoperative pain assessed pharmacokinetics (PK) and safety, in addition to efficacy and pharmacodynamics of repeated doses administered over 24 hours. Neonate and infant patients (
ISSN:0091-2700
1552-4604
DOI:10.1002/jcph.1508