Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Albert B. Sabin Vaccine Institute
• Treatments: Fentanyl; Tramadol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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