Meanwhile it is widely accepted, that ventilated newborns and infants should receive analgesia and sedation for ethical and medical reasons. In this context fentanyl belongs to the mosten often used opioids, with the important disadvantage of prolonged depression of respiratory drive after discontinuation of the infusion. In this clinical trial ventilated term newborns and infants (<60 days) receive either remifentanil or fentanyl for analgesia and sedation.
Conditions
Interventions
Trade Name: Ultiva
Product Name: Remifentanil
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Remifentanilhydrochlorid
CAS Number: 132539072
Other descriptive name: Ultiva
Concentration
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ventilated term newborns and infants =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Various conditions of neuromuscular impairment e.g. severe peripartal asphyxia, cerebral infarct, congenital muscular diseases or metabolic defects showing distinct neuromuscular symptoms. Drug abuse of the mother (exclusion criterion for newborns). Known hypersensitivity to Ultiva®, Fentanyl-Janssen® or fentanyle equivalents. Missing informed consent of the parents. Participation in another clinical trial during or within the last 4 weeks before start of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Duration of the artificial ventilation after discontinuation of the opioid infusion.;Secondary Objective: Efficacy and safety of a remifentanil based analgesia and sedation of ventilated newborns and infants. Occurance of tolerance to the analgesic effect of the opioids. Occurance of hyperalgesia after discontinuation of the opioid infusion. Possible withdrawal symptoms in both treatment groups after extubation. Discharge time from the PICU after discontinuation of the opioid infusion.;Primary end point(s): We want to investigate, whether ventilated neonates and infants with a remifentanil based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyle based analgesia and sedation. | — |
Countries
Germany
Outcome results
None listed