Analgesia, Neonatal Infections, Pain
Conditions
Keywords
Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
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.
Interventions
DRUGFentanyL
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.
DRUGTramadol
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.
Sponsors
Albert B. Sabin Vaccine Institute
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time between surgical procedure and successful extubation | Hospital stay |
| Time between surgical procedure and achievement of 100 mL/kg of enteral feeding | hospital stay |
Countries
Brazil
Outcome results
None listed