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Oxycodone Pharmacokinetics in Preterm Infants

NCT ID: NCT02564003

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Oxycodone

Oxycodone 0,1 mg/kg iv

Oxycodone

Intervention Type DRUG

oxycodone 0,1 mg/kg iv

Interventions

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Oxycodone

oxycodone 0,1 mg/kg iv

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Admescope Ltd

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, Docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2011-11-11

Identifier Type: -

Identifier Source: org_study_id