title: Remifentanil/midazolam versus fentanyl/midazolam for analgesia and sedation of mechanically ventilated neonates and young infants: a randomized controlled trial.
abstract: OBJECTIVE
  Common opioids for analgesia and sedation of mechanically ventilated infants may tend to accumulate and cause prolonged sedation with an unpredictable extubation time. Remifentanil is a promising option due to its unique pharmacokinetic properties, which seem to be valid in adults as well as in infants.
  
  
  METHODS
  In this double-blind, randomized, controlled trial mechanically ventilated neonates and young infants (<60 days) received either a remifentanil or fentanyl-based analgesia and sedation regimen with low dose midazolam. The primary endpoint of the trial was the extubation time following discontinuation of the opioid infusion. Secondary endpoints included efficacy and safety aspects.
  
  
  RESULTS
  Between November 2006 and March 2010, we screened 431 mechanically ventilated infants for eligibility. The intention to treat group included 23 infants who were assigned to receive either remifentanil (n = 11) or fentanyl (n = 12). Although this was designed as a pilot study, median extubation time was significantly shorter in the remifentanil group (80.0 min, IQR = 15.0-165.0) compared to the fentanyl group (782.5 min, IQR = 250.8-1,875.0) (p = 0.005). Remifentanil and fentanyl provided comparable efficacy with more than two-thirds of the measurements indicating optimal analgesia and sedation (66.4 and 70.2 %, respectively; p = 0.743). Overall, both groups had good hemodynamic stability and a comparably low incidence of adverse events.
  
  
  CONCLUSIONS
  As neonates and young infants have a decreased metabolism of common opioids like fentanyl and are more prone to respiratory depression, remifentanil could be the ideal opioid for analgesia and sedation of mechanically ventilated infants.
authors.affiliation: Department of Neonatology and Paediatric Intensive Care, Childrens Hospital, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany. lars.welzing@uk-koeln.de
authors.forename: Lars
authors.initials: L
authors.lastname: Welzing
authors.forename: Andre
authors.initials: A
authors.lastname: Oberthuer
authors.forename: Shino
authors.initials: S
authors.lastname: Junghaenel
authors.forename: Urs
authors.initials: U
authors.lastname: Harnischmacher
authors.forename: Hartmut
authors.initials: H
authors.lastname: Stützer
authors.forename: Bernhard
authors.initials: B
authors.lastname: Roth
mesh_terms: D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use*; D006776:Hospitals, Pediatric; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008874:Midazolam / Q000008:administration & dosage / Q000627:therapeutic use*; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D000077208:Remifentanil; D012121:Respiration, Artificial; D016896:Treatment Outcome
chemical_list: D018686:Anesthetics, Intravenous; D010880:Piperidines; D000077208:Remifentanil; D008874:Midazolam; D005283:Fentanyl