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Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

NCT00713726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2008-07-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Albert B. Sabin Vaccine Institute

    collaborator OTHER

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Ruth Guinsburg, MD · Federal University of São Paulo

  • Ana Julia C Alencar · Federal university of são Paulo and Albert Sabin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00713726 on ClinicalTrials.gov