Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713726
• Other study ID #: 1386/06
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2008
• Last updated: July 10, 2008
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Neonatal Infections
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Albert Sabin Hospital	Fortaleza	Ceará

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Albert B. Sabin Vaccine Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time between surgical procedure and successful extubation		Hospital stay	Yes
Secondary	Time between surgical procedure and achievement of 100 mL/kg of enteral feeding		hospital stay	Yes