Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Federal University of São Paulo160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Pain Neonatal Infections Analgesia

Interventions

FentanyLDRUG

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.

TramadolDRUG

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.

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (1)

Albert Sabin Hospital

Fortaleza, Ceará, Brazil

Outcomes

Primary Outcomes

Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure

Time frame: Every 2-4h during the first 72 hours after surgical procedure

Secondary Outcomes

Time between surgical procedure and successful extubation

Time frame: Hospital stay

Time between surgical procedure and achievement of 100 mL/kg of enteral feeding

Time frame: hospital stay

Data from ClinicalTrials.gov

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