Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
- Registration Number
- NCT00713726
- Lead Sponsor
- Federal University of São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description F FentanyL Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop T Tramadol Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
- Primary Outcome Measures
Name Time Method Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure Every 2-4h during the first 72 hours after surgical procedure
- Secondary Outcome Measures
Name Time Method Time between surgical procedure and successful extubation Hospital stay Time between surgical procedure and achievement of 100 mL/kg of enteral feeding hospital stay
Trial Locations
- Locations (1)
Albert Sabin Hospital
🇧🇷Fortaleza, Ceará, Brazil