Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

Turku University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness

Interventions

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.

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.

Time frame: 24 hours post-dose.

Secondary Outcomes

Effect of biometric and genomic covariates on AUC

Covariate analysis and simulations to individualize population models

Time frame: 24 hours post-dose

Efficacy of propofol in procedural anesthesia in neonates

Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates

Time frame: 24 hours

Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation

Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.