Analgesia/sedation Signs and Symptoms Analgesia
Conditions
Interventions
Test group:
Permanent remifentanil infusion with a primary dose of 9 microgram/kg/h titrated to the individual need of the test person up to a maximum dose of 30 microgram/kg/h.
Sponsors
University of Cologne (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ventilated term newborns and infants less than 60 days 2. Expected time of artificial ventilation between 12 and 96 hours
Exclusion criteria
Exclusion criteria: 1. Neuromuscular diseases 2. Drug abuse of the mother (exclusion criteria for newborns) 3. Known hypersensitivity to Ultiva® and Fentanyl-Janssen® 4. Missing informed consent of the parents 5. Participation in another clinical trial during the last four weeks before start of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shortening of the artificial ventilation after discontinuation of the opioid infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Documentation of the efficacy and safety of a remifentanil based analgesia and sedation of ventilated newborns and infants 2. Documentation of a potentially occuring tolerance to the analgesic effect of the opioids 3. Documentation of a potentially occuring hyperalgesia after discontinuation of the opioid infusion 4. Documentation of possible withdrawal symptoms on both treatment groups after extubation 5. Documentation of the discharge time from the Paediatric Intensive Care Unit (PICU) after discontinuation of the opioid infusion | — |
Countries
Germany
Outcome results
None listed