Oxycodone Pharmacokinetics in Preterm Infants

Kuopio University Hospital79 enrolled

Overview

The pharmacokinetics of oxycodone is well characterized in children older than six months of age. However, only one study has been published with children younger than six months, concluding that unexplained inter-individual variability is pronounced in the youngest children. The aim of the current study was to quantify oxycodone pharmacokinetics in children ranging from preterm newborn infants to children up to two years of age.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pain

Interventions

OxycodoneDRUG

oxycodone 0,1 mg/kg iv

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infants scheduled for surgery with planned perioperative or postoperative opioid analgesia were screened if the gestational age (GA) was at least 23 weeks and postnatal age (PNA) below 2 years Exclusion Criteria: * He/she had allergy or hypersensitivity to oxycodone or other ingredients in the formulations or had received monoamineoxidase, CYP3A (cytochrome P450 3A enzymes) or CYP2D6 (cytochrome P450 2D6 enzyme) inhibitors during the previous month or other reason that was considered to contraindicate participation.

Outcomes

Primary Outcomes

Peak plasma concentration of oxycodone

Time frame: time zero hours to 24 hours

Data from ClinicalTrials.gov

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