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NCT02564003 Clinical Trial

Oxycodone Pharmacokinetics in Preterm Infants

Pain Clinical Trial

— oksineoinfa  

Official title:
Oxycodone Pharmacokinetics in Preterms, Infants and Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02564003
Other study ID # 2011-11-11
Secondary ID
Status Completed
Phase Phase 4
First received September 25, 2015
Last updated September 29, 2015
Start date June 2012
Est. completion date August 2013

Study information
Verified date September 2015
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone
oxycodone 0,1 mg/kg iv

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Kuopio University Hospital Admescope Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Peak plasma concentration of oxycodone time zero hours to 24 hours Yes
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