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Clinical Trials/ISRCTN06135415
ISRCTN06135415
Completed
未知

Prospective, randomised, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants

niversity of Cologne (Germany)0 sites24 target enrollmentJanuary 3, 2007

Overview

Phase
未知
Intervention
Not specified
Conditions
Analgesia/sedation
Sponsor
niversity of Cologne (Germany)
Enrollment
24
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22456770 (added 10/04/2019)

Registry
who.int
Start Date
January 3, 2007
End Date
August 17, 2008
Last Updated
6 years ago
Study Type
Interventional

Investigators

Sponsor
niversity of Cologne (Germany)

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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