Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

NCT ID: NCT02426463

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-20
• Study Completion Date: 2019-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

oxycodone

Intervention Type: DRUG

Interventions

propofol

Intervention Type: DRUG

oxycodone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teijo I Saari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Anaesthesiology and Intensive Care, University Of Turku

Locations

Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

T65/2015

Identifier Type: -

Identifier Source: org_study_id