Analgesia, sedation.
Conditions
Sponsors
Kern Pharma S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed by parents or legal guardians. 2. Neonatal patients between 0 and 27 days of postnatal age and >= 37 weeks of gestational age admitted to the NICU of Cruces Universitary Hospital. 3. Treatment with iv fentanyl with analgesic or sedatives purposes, or with other indications by facultative prescription. 4. First stage of fentanyl treatment following the sedoanalgesia protocol of the NICU of the Cruces Universitary Hospital. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Sepsis. 2. Liver failure. 3. Renal replacement therapy. 4 Hypersensitivity to fentanyl or opioids in general. 5. Cranioencephalic trauma, increased of intracranial pressure and/or coma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Study the pharmacokinetic behavior of fentanyl as an analgesic/sedative agent in neonates aged 0-27 days of postnatal age and >= 37 weeks of gestational age admitted to the Neonatal Intensive Care Unit (NICU), in order to confirm a predictive model developed for the drug in this population. -Analyze the role of those factors that may play an important role in the pharmacokinetic variability associated with fentanyl in the study population.;Secondary Objective: -Identify, between physiological parameters monitored in the NICU, an end-point or marker of efficacy that may be related to the degree of analgesia and sedation. This will be done through a study of correlations and the development of pharmacostatistical models (eg, pharmacokinetic-pharmacodynamic type, PK/PD) in order to optimize the dosage of fentanyl in this population.;Primary end point(s): Step 1: Determination of the basic population pharmacokinetic model. First, the basic population pharmacokinetic model (compartmental analyses) that best describes the temporal evolution of the plasma concentrations of fentanyl in the population is selected. The following parameters from the data of plasma concentration measured in this study will be estimated: - V1: Distribution volume of the drug in the central compartment of the body (Units: L) -CL: Systemic clearance: central compartment volume that is cleared of drug per time unit (units: L / h) -V2: Distribution volume of the drug in the peripheral compartment of rapid distribution (Units: L) -V3: Distribution volume of the drug in the peripheral compartment of slow distribution (Units: L) -CLd1-2: Disribution clearance or intercompartmental clearance between the central compartment and the peripheral compartment of rapid distribution (Units: L / h) -CLd1-3: Disribution clearance or intercompartmental clearance between the central compartment and the peripheral compartment of slow distribution (Units: L / h) Step 2: Selection of predictor variab | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamic analysis The model that commonly best fits the effects of opioid drugs corresponds with a sigmoid model of maximum effect (Emax). However, the pharmacological effects of opioids generally show a delay with respect to the plasma concentration, being necessary to introduce what is known as the effect compartment model. The parameters that include this type of model are summarized below: -Ke0: Equilibrium constant between the plasma compartment and the effect compartment or biophase (units: h-1) -t1/2Ke0: Equilibrium half-life between the plasma compartment and the effect compartment or biophase (units: h) - CE50: Plasma concentration that produces 50% of the maximum effect (Units: ng / mL) - Emax: Maximum effect for that particular drug (%) -?: Hill constant or slope of the sigmoidal curve At least, the following variables as potential markers of clinical effect (effective and / or toxic) will be scanned: - Heart rate - Scheduled Respiratory rate - Spontaneous Respiratory rate - Peak pressure - Positive end-expiratory pressure (PEEP) - Saturation transcutaneous - Brain Saturation (cerebral oximetry) - Clinical Pain Scale;Timepoint(s) of evaluation of this end point: During the study | — |
Countries
Spain
Contacts
Public ContactClinical Trial Information
DynaKin S.L.
Outcome results
None listed