Children aged less than 2 years that are hospitalized due to bronchiolitis and need sedation and analgesia with fentanyl. MedDRA version: 12.1 Level: PT Classification code 10006448 Term: Bronchiolitis MedDRA version: 12.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis
Conditions
Interventions
Trade Name: Fentanil Torrex 50 mikrogramov/ml raztopina za injiciranje
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: FENTANYL CITRATE
CAS Number: 990-73-8
Concentration unit: µg/ml mi
Sponsors
Faculty of pharmacy, University of Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children: • of both sexes with bronchiolitis that are mechanically ventilated • that are hospitalized on Division of Surgery, Department of Paediatric Surgery and Intensive Care (University medical centre Ljubljana) • that need sedation with continuous infusion of fentanyl for at least 3 days • whose parents or legal representatives are informed of the course of the research and signed the informed consent form 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: Children: • who weight less than 3 kg • who are older than 2 years • that have terapy with other opioid analgetics • with brain injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate clinical, demographic and genetic factors that influence pharmacokinetics and pharmacodynamics (EEG) of fentanyl.;Secondary Objective: To establish the relationship between pharmacokinetics/pharmacodynamics and efficacy/safety of continuous intravenous infusion of fentanyl in pediatric population. To quantify tolerance and withdrawal symptoms. ;Primary end point(s): BIS, COMFORT-B, Modified Finnegan score | — |
Countries
Slovenia
Outcome results
None listed