Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Neonatal Infections; Analgesia; Pain

Treatments: Drug: FentanyL; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT00713726

1386/06

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

F

Active Comparator group

Description:

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

Treatment:

Drug: FentanyL

T

Experimental group

Description:

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

Treatment:

Drug: Tramadol