Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Collaborator: GlaxoSmithKline
• Treatments: Fentanyl; Remifentanil

Criteria

Inclusion Criteria:

• Ventilated term newborns and infants ≤ 60 days

• Expected time of artificial ventilation between 12 and 96 hours

Exclusion Criteria:

• Neuromuscular diseases

• Drug abuse of the mother (exclusion criteria for newborns)

• Known hypersensitivity to Ultiva® or Fentanyl-Janssen®

• Missing informed consent of the parents

• Participation in another clinical trial during the last 4 weeks before start of this trial