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Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

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ClinicalTrials.gov Identifier: NCT00713726
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : July 11, 2008
Sponsor:
Collaborator:
Albert B. Sabin Vaccine Institute
Information provided by:
Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE July 9, 2008
First Posted Date  ICMJE July 11, 2008
Last Update Posted Date July 11, 2008
Study Start Date  ICMJE January 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
Official Title  ICMJE Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Neonatal Infections
  • Analgesia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: FentanyL
  • Experimental: 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
    Intervention: Drug: Tramadol
Publications * Alencar AJ, Sanudo A, Sampaio VM, Góis 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2008)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00713726
Other Study ID Numbers  ICMJE 1386/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruth Guinsburg, MD, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Albert B. Sabin Vaccine Institute
Investigators  ICMJE
Study Director: Ruth Guinsburg, MD Federal University of São Paulo
Principal Investigator: Ana Julia C Alencar Federal university of são Paulo and Albert Sabin Hospital
PRS Account Federal University of São Paulo
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP