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Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

NCT02426463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-02-04

No results posted yet for this study

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

Interventions

DRUG

propofol

DRUG

oxycodone

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Teijo I Saari, MD, PhD · Dept. Anaesthesiology and Intensive Care, University Of Turku

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-20
Primary Completion
2017-02-28
Completion
2019-01-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426463 on ClinicalTrials.gov