Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl
Conditions
Brief summary
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at zero-time, within 30 min of the administration of the starting bolus, after 24-48-72-96 hours infusion will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.
Detailed description
To evaluate the safety of the Fentanyl regimen (load of 2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 1 mcg/kg/h for TH and heating fase) by recording drug side effect
Interventions
DRUGFENTANYL
Sponsors
Azienda Ospedaliero Universitaria Di Modena
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at zero-time, within 30 min of the administration of the starting bolus, after 24-48-72-96 hours infusion will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of the Fentanyl regimen (load of 2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 1 mcg/kg/h for TH and heating fase) by recording drug side effect | — |
Countries
Italy
Outcome results
None listed