Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants - Full Text View

Sponsors and Collaborators:	Federal University of São Paulo Albert B. Sabin Vaccine Institute
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00713726

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 III

MedlinePlus related topics: Surgery

Drug Information available for: Fentanyl Citrate Fentanyl Tramadol hydrochloride Tramadol

U.S. FDA Resources

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

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
F: Active Comparator 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.
T: Experimental 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, Ceará
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

Responsible Party:	Federal University of São Paulo ( Ruth Guinsburg, MD )
Study ID Numbers:	1386/06
Study First Received:	July 9, 2008
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00713726
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

Study placed in the following topic categories:

Fentanyl
Tramadol
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Infection
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 10, 2009