Oxycodone Pharmacokinetics in Preterm Infants

Oxycodone Pharmacokinetics in Preterms, Infants and Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02564003

Acronym

oksineoinfa

Enrollment

Registered

2015-09-30

Start date

2012-06-30

Completion date

2013-08-31

Last updated

2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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.

Interventions

DRUGOxycodone

oxycodone 0,1 mg/kg iv

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Peak plasma concentration of oxycodone	time zero hours to 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026