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. Patients between 28 days and 16 years of age admitted to the PICU of Gregorio Marañón 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 PICU of the Gregorio Marañón Hospital. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Study the pharmacokinetics of fentanyl in patients aged from 1 month to 16 years admitted to the Pediatric Intensive Care Unit (PICU) receiving fentanyl as an analgesic/sedative agent. -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 PICU, a marker of efficacy that may be related to the degree of analgesia and sedation, through the development of pharmacostatistical models (eg, pharmacokinetic-pharmacodynamic type, PK/PD). -Exploratory Objective: Study the possible influence of the concentration of plasma proteins on the pharmacokinetics of fentanyl;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 variables. At this level, the relationship between pharmacokinetic parameters and possible predictors there | — |
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) - BIS - EEG suppression rate - Conductance - Electromyogram - Scale COMFORT sedation, analgesia Scale - Withdrawal: Sophia 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