Prospective, randomized, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants - RAPIP-Pilotstudie
- Conditions
- 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.
- Registration Number
- EUCTR2005-003516-29-DE
- Lead Sponsor
- niversität zu Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Ventilated term newborns and infants < 60 days.
Expected time of artificial ventilation between 12 and 96 hours.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Occurance of tolerance to the analgesic effect of the opioids.<br>Occurance of hyperalgesia after discontinuation of the opioid infusion.<br>Possible withdrawal symptoms in both treatment groups after extubation.<br>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.<br>
- Secondary Outcome Measures
Name Time Method