Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

Phase 4

Completed

• Conditions: Critical Illness
• Interventions: Drug: oxycodone; Drug: propofol

• Registration Number: NCT02426463
• Lead Sponsor: Turku University Hospital

Brief Summary

Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.

Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-13
• Study Start: 2015-04-20
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2017-02-28
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Given informed consent by the guardian of an eligible patient.
• Patient is more than 24 weeks old and has a body weight more than 500 g.
• Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.

Exclusion Criteria

• Eligible patients guardian declines to give informed consent.
• A previous history of intolerance to the study drugs or to related compounds and additives.
• History of any kind of drug allergy.
• Participation in any other studies concomitantly or within one month prior to the entry into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxycodone	oxycodone	Plasma samples and patient data are collected prospectively from 40 neonates who receive oxycodone as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
Propofol	propofol	Plasma samples and patient data are collected prospectively from 40 neonates who receive propofol as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.	24 hours post-dose.	Primary outcome is to build up a population pharmacometric model to describe pharmacokinetics of propofol and oxycodone based on drug concentrations analyzed from the plasma samples.

Secondary Outcome Measures

Name	Time	Method
Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation	24 hours	Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.
Effect of biometric and genomic covariates on AUC	24 hours post-dose	Covariate analysis and simulations to individualize population models
Efficacy of propofol in procedural anesthesia in neonates	24 hours	Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates

Trial Locations

Locations (1)

Department of Paediatrics and Adolescent Medicine, Turku University Hospital; 🇫🇮 Turku, Finland