Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00713726

Collaborator

Albert B. Sabin Vaccine Institute (Other)

160

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Neonatal Infections Analgesia	Drug: FentanyL Drug: Tramadol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure [Every 2-4h during the first 72 hours after surgical procedure]

Secondary Outcome Measures

Time between surgical procedure and successful extubation [Hospital stay]
Time between surgical procedure and achievement of 100 mL/kg of enteral feeding [hospital stay]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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