Trial | NCT00713726  Report issue

Title

Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    160
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.
Study Started
Jan 31
2006
Primary Completion
Jul 31
2008
Study Completion
Jul 31
2008
Last Update
Jul 11
2008
Estimate

Drug FentanyL

Fentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.

Drug Tramadol

Tramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.

T Experimental

Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop

F Active Comparator

Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop

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
No Results Posted