Status:
COMPLETED
Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Mechanical Ventilation
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE3
Brief 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 neona...
Detailed Description
"Newborns (≥ 36 weeks of gestation) and young infants (≤ 60 days) with need of mechanical ventilation receive next to midazolam either remifentanyl or fentanyl for analgesia and sedation. The study me...
Eligibility Criteria
Inclusion
- Ventilated term newborns and infants ≤ 60 days
- Expected time of artificial ventilation between 12 and 96 hours
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00419601
Start Date
November 1 2006
End Date
April 1 2010
Last Update
June 25 2010
Active Locations (1)
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1
Clinic for Paediatrics, University of Cologne Kerpener Str. 62
Cologne, Germany, 50937