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Trial record 3 of 663 for:    OXYCODONE

Oxycodone Pharmacokinetics in Preterm Infants (oksineoinfa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02564003
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Admescope Ltd
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

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.

Condition or disease Intervention/treatment
Pain Drug: Oxycodone

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oxycodone Pharmacokinetics in Preterms, Infants and Children
Study Start Date : June 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Peak plasma concentration of oxycodone [ Time Frame: time zero hours to 24 hours ]

Biospecimen Retention:   Samples Without DNA
Plasma and urine samples for oxycodone concentration measurement

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children age from 23 gestational weeks to two years

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.

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Responsible Party: Merja Kokki, MD, Docent, Kuopio University Hospital Identifier: NCT02564003     History of Changes
Other Study ID Numbers: 2011-11-11
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents