Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
NCT ID: NCT00713726
Last Updated: 2008-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2006-01-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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F
Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
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.
T
Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* New surgery until 72 hours after the studied surgical procedure
* Proved bacterial infection before surgery
* Ambiguous genitalia
* Chromosomal syndromes
28 Days
ALL
No
Sponsors
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Albert B. Sabin Vaccine Institute
OTHER
Federal University of São Paulo
OTHER
Responsible Party
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Federal University of São Paulo
Principal Investigators
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Ruth Guinsburg, MD
Role: STUDY_DIRECTOR
Federal University of São Paulo
Ana Julia C Alencar
Role: PRINCIPAL_INVESTIGATOR
Federal university of são Paulo and Albert Sabin Hospital
Locations
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Albert Sabin Hospital
Fortaleza, Ceará, Brazil
Countries
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References
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Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.
Other Identifiers
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1386/06
Identifier Type: -
Identifier Source: org_study_id