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Trial record 3 of 663 for:    OXYCODONE

Oxycodone Pharmacokinetics in Preterm Infants (oksineoinfa)

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ClinicalTrials.gov Identifier: NCT02564003
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
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
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


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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
Criteria

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
ClinicalTrials.gov 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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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents