Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

NCT00713726 | Completed Phase 3 DMC

• 1 other identifier: 1386/06
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Neonatal Infections; Analgesia

Keywords

Pain; Analgesia; Newborn Infant; Opioids; Side-effects; Intensive care; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time between surgical procedure and successful extubation

  Hospital stay

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

  hospital stay

Study Arms (2)

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

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

Interventions

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.

F

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.

T

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Albert B. Sabin Vaccine Institute: collaborator

Study Sites (1)

Albert Sabin Hospital

Fortaleza, Ceará, 60.410.790, Brazil

Location

Related Publications (1)

• Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.

  PMID: 21471025 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Fentanyl; Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Ruth Guinsburg, MD

  Federal University of São Paulo

  STUDY DIRECTOR

• Ana Julia C Alencar

  Federal university of são Paulo and Albert Sabin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 11, 2008

Record last verified: 2008-07

Locations

BR (1)