Status:
COMPLETED
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Albert B. Sabin Vaccine Institute
Conditions:
Pain
Neonatal Infections
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE3
Brief Summary
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.
Eligibility Criteria
Inclusion
- Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)
Exclusion
- Death or hospital discharge until 72 hours after surgical procedure
- New surgery until 72 hours after the studied surgical procedure
- Proved bacterial infection before surgery
- Ambiguous genitalia
- Chromosomal syndromes
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00713726
Start Date
January 1 2006
End Date
July 1 2008
Last Update
July 11 2008
Active Locations (1)
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1
Albert Sabin Hospital
Fortaleza, Ceará, Brazil, 60.410.790