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Completed

NCT Number: NCT00713726

Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

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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Key information

Conditions

Pain Agnosia Analgesia Neonatal Infections Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Albert Sabin Hospital

Fortaleza, Ceará, 60.410.790, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

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.

Tramadol

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.

Primary outcomes

  1. 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 outcomes

  1. Time between surgical procedure and successful extubation

    Time frame: Hospital stay

  2. Time between surgical procedure and achievement of 100 mL/kg of enteral feeding

    Time frame: hospital stay

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Albert B. Sabin Vaccine Institute

Registry information

Official study title

Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Jul 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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