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Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

This study has been completed.
Sponsor:
Collaborator:
Albert B. Sabin Vaccine Institute
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00713726
First received: July 9, 2008
Last updated: July 10, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Neonatal Infections
Analgesia
 Drug: FentanyL
Drug: Tramadol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time between surgical procedure and successful extubation [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
  • Time between surgical procedure and achievement of 100 mL/kg of enteral feeding [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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.
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
 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

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713726

Locations
Brazil
Albert Sabin Hospital
Fortaleza, Ceará, Brazil, 60.410.790
Sponsors and Collaborators
Federal University of São Paulo
Albert B. Sabin Vaccine Institute
Investigators
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
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ruth Guinsburg, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00713726     History of Changes
Other Study ID Numbers: 1386/06
Study First Received: July 9, 2008
Last Updated: July 10, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Pain
Analgesia
Newborn Infant
Opioids
 Side-effects
Intensive care
Postoperative

Additional relevant MeSH terms:
Fentanyl
Tramadol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013