NCT02564003

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

September 25, 2015

Last Update Submit

September 29, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Peak plasma concentration of oxycodone

    time zero hours to 24 hours

Study Arms (1)

Oxycodone

Oxycodone 0,1 mg/kg iv

Drug: Oxycodone

Interventions

OxycodoneDRUG

oxycodone 0,1 mg/kg iv

Oxycodone

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children age from 23 gestational weeks to two years

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples for oxycodone concentration measurement

MeSH Terms

Conditions

Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Docent

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 30, 2015

Study Start

June 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 30, 2015

Record last verified: 2015-09