children requiring analgosedation with tramadol
Conditions
Interventions
Trade Name: Tramabene 50 inj.
Product Name: tramadol
Pharmaceutical Form: Intravenous infusion
Sponsors
Všeobecná fakultní nemocnice v Praze
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: analgosedation with tramadol Are the trial subjects under 18? yes Number of subjects for this age range: 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. Patients suffering from an abstinence syndrome as a result of a proven abuse of drugs by mother; 2. Patients suffering from an acute spasm attack, a neuromuscular disease or neuromuscular relaxation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. to estimate developmental changes of pharmacokinetic parameters of tramadol in children of various ages; and 2. to determine and clarify to what extent the CYP2D6 genotype is a prediction factor of variability of pharmacokinetic parameters in small children. ;Secondary Objective: 1. to identify the correlation between clinical effects and pharmacokinetic parameters in different age brackets; and 2. to monitor the incidence of undesirable side effects of the CYP2D6 genotype and pharmacokinetic parameters in respect to the age of patients. ;Primary end point(s): Time -concentration profiles of tramadol and M1, pharmacokinetics of the drug vs. CYP2D6 genotype. | — |
Countries
Czech Republic
Outcome results
None listed