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Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713726
First Posted: July 11, 2008
Last Update Posted: July 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Albert B. Sabin Vaccine Institute
Information provided by:
Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 9, 2008
First Posted: July 11, 2008
Last Update Posted: July 11, 2008
Last Verified: July 2008

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

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics