Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Neonatal Infections Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

FentanyL

Intervention Type DRUG

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

Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No