Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

NCT02426463 | Completed Phase 4

• 1 other identifier: T65/2015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Neonatal intensive care; need for intratracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours post-dose.

Secondary Outcomes (3)

• Effect of biometric and genomic covariates on AUC

  24 hours post-dose

• Efficacy of propofol in procedural anesthesia in neonates

  24 hours

• Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation

  24 hours

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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.

Drug: propofol

Oxycodone

ACTIVE COMPARATOR

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.

Drug: oxycodone

Interventions

propofol DRUG

Propofol

oxycodone DRUG

Oxycodone

Eligibility Criteria

• Age: 24 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Propofol; Oxycodone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Teijo I Saari, MD, PhD

  Dept. Anaesthesiology and Intensive Care, University Of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 27, 2015
• Study Start: April 20, 2015
• Primary Completion: February 28, 2017
• Study Completion: January 31, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FI (1)