Back to resultsTramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Primary Purpose
Pain, Neonatal Infections, Analgesia
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
FentanyL
Tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
Eligibility Criteria
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
Sites / Locations
- Albert Sabin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
F
T
Arm 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
Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
Outcomes
Primary Outcome Measures
Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
Secondary Outcome Measures
Time between surgical procedure and successful extubation
Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
Full Information
NCT ID
NCT00713726
First Posted
July 9, 2008
Last Updated
July 10, 2008
Sponsor
Federal University of São Paulo
Collaborators
Albert B. Sabin Vaccine Institute
1. Study Identification
Unique Protocol Identification Number
NCT00713726
Brief Title
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Official Title
Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Albert B. Sabin Vaccine Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neonatal Infections, Analgesia
Keywords
Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F
Arm Type
Active Comparator
Arm 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
Arm Title
T
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
FentanyL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time between surgical procedure and successful extubation
Time Frame
Hospital stay
Title
Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
Time Frame
hospital stay
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Guinsburg, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Julia C Alencar
Organizational Affiliation
Federal university of são Paulo and Albert Sabin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Sabin Hospital
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60.410.790
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21471025
Citation
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.
Results Reference
derived
Learn more about this trial
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
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