NCT00713726

Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Neonatal Infections
• Analgesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-07-11
• Last updated: 2008-07-11

Locations

1 site across 1 country: Brazil