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| Name | Class |
|---|---|
| University of Turku | OTHER |
| University of Helsinki | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug |
| ||
| oxycodone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of biometric and genomic covariates on AUC | Covariate analysis and simulations to individualize population models | 24 hours post-dose |
| Efficacy of propofol in procedural anesthesia in neonates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teijo I Saari, MD, PhD | Dept. Anaesthesiology and Intensive Care, University Of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics and Adolescent Medicine, Turku University Hospital | Turku | 20521 | Finland |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates
| 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. | 24 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |