title: Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates.
abstract: OBJECTIVE
  To assess, in newborn infants submitted to surgical procedures, the efficacy of two opioids-fentanyl and tramadol-regarding time to extubate, time to achieve 100 ml/kg of enteral feeding and pain in the first 72 h after surgery.
  
  
  METHODS
  Controlled, blind, randomised clinical trial.
  
  
  METHODS
  Neonatal intensive care unit.
  
  
  METHODS
  160 newborn infants up to 28 days of life requiring major or minor surgeries.
  
  
  METHODS
  Patients were randomised to receive analgesia with fentanyl (1-2 μg/kg/h intravenously) or tramadol (0.1-0.2 mg/kg/h intravenously) in the first 72 h of the postoperative period, stratified by surgical size and by patient's gender.
  
  
  METHODS
  Pain assessed by validated neonatal scales (Crying, Requires oxygen, Increased vital signs, Expression and Sleepless Scale and the Neonatal Facial Coding System), time until extubation and time to reach 100 ml/kg enteral feeding. Statistical analysis included repeated measures analysis of variance adjusted for confounding variables and Kaplan-Meier curve adjusted by a Cox model of proportional risks.
  
  
  RESULTS
  Neonatal characteristics were (mean±SD) birth weight of 2924±702 g, gestational age of 37.6±2.2 weeks and age at surgery of 199±63 h. The main indication of surgery was gastrointestinal malformation (85 newborns; 53%). Neonates who received fentanyl or tramadol were similar regarding time until extubation, time to reach 100 ml/kg of enteral feeding and pain scores in the first 72 h after surgery.
  
  
  CONCLUSIONS
  Tramadol was as effective as fentanyl for postoperative pain relief in neonates but does not appear to offer advantages over fentanyl regarding the duration of mechanical ventilation and time to reach full enteral feeding. Trial registration NCT00713726.
authors.affiliation: Federal University of São Paulo, Rua Vicente Felix 77, São Paulo, SP, Brazil.
authors.forename: Ana Julia Couto
authors.initials: AJ
authors.lastname: Alencar
authors.forename: Adriana
authors.initials: A
authors.lastname: Sanudo
authors.forename: Virginia Maria Ramos
authors.initials: VM
authors.lastname: Sampaio
authors.forename: Rôsicler Pereira
authors.initials: RP
authors.lastname: Góis
authors.forename: Fernando Antônio Barbosa
authors.initials: FA
authors.lastname: Benevides
authors.forename: Ruth
authors.initials: R
authors.lastname: Guinsburg
mesh_terms: D000698:Analgesia / Q000379:methods; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D001724:Birth Weight; D020878:Device Removal; D004750:Enteral Nutrition; D004812:Epidemiologic Methods; D005260:Female; D005283:Fentanyl / Q000009:adverse effects / Q000627:therapeutic use*; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007442:Intubation, Intratracheal; D008297:Male; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000517:prevention & control*; D011182:Postoperative Care / Q000379:methods; D011184:Postoperative Period; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000701:Analgesics, Opioid; D014147:Tramadol; D005283:Fentanyl