Oxycodone Pharmacokinetics in Preterm Infants (oksineoinfa)

September 29, 2015 updated by: Merja Kokki, Kuopio University Hospital

Oxycodone Pharmacokinetics in Preterms, Infants and Children

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

79

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children age from 23 gestational weeks to two years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oxycodone
Oxycodone 0,1 mg/kg iv
Drug: Oxycodone
oxycodone 0,1 mg/kg iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration of oxycodone
Time Frame: time zero hours to 24 hours
time zero hours to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Admescope Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-11-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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