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Continuous infusion of clonidine in ventilated newborns and infants: a randomized controlled trial
Christoph Hünseler1, Gunter Balling, Christoph Röhlig
11Department of Neonatology and Pediatric Intensive Care, University of Cologne, Children's Hospital, Köln, Germany. 2Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, TUM, München, Germany. 3Department of Pediatric Anesthesia, DRK Children's Hospital, Siegen, Germany. 4Department of Anaesthesiology and Postoperative Intensive Care Medicine, University of Cologne, Köln, Germany. 5Department of Neonatology, University Hospital Halle, Halle, Germany. 6Department of Pediatric Intensive Care, Children's Hospital of the University of Essen, Essen, Germany. 7Department of Pediatrics, Hospital of the University of Leipzig, Leipzig, Germany. 8Department of Pediatrics III, University of Göttingen, Göttingen, Germany. 9Department of Pediatric Anaesthesia, Children's Hospital of the City of Cologne, Köln, Germany. 10Department of Pediatrics, Neonatology and Intensive Care, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany. 11Department of Pediatric Cardiology, German Heart Center of Berlin, Berlin, Germany. 12Department of Pediatrics, Hospital of the University of Freiburg, Freiburg, Germany. 13Department of Pediatrics, Intensive Care, University of Mainz, Mainz, Germany. 14Department of Neonatology, University Hospital of Bonn, Bonn, Germany. 15Department of Therapeutic Drug Monitoring, Institute of Pharmacology, University of Cologne, Köln, Germany. 16Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Köln, Germany. 17Center of Clinical Studies, University of Cologne, Köln, Germany.
Objectives:
To assess the influence of an infusion of clonidine 1 μg/kg/hr on fentanyl and midazolam requirement in ventilated newborns and infants.
Design:
Prospective, double-blind, randomized controlled multicenter trial. Controlled trials.com/ISRCTN77772144.
Setting:
Twenty-eight level 3 German PICUs/neonatal ICUs.
Patients:
Ventilated newborns and infants: stratum I (1-28 d), stratum II, (29-120 d), and stratum III (121 d to 2 yr).
Interventions:
Patients received clonidine 1 μg/kg/hr or placebo on day 4 after intubation. Fentanyl and midazolam were adjusted to achieve a defined level of analgesia and sedation according to Hartwig score.
Measurements And Main Results:
Two hundred nineteen infants were randomized; 212 received study medication, 69.7% were ventilated in the postoperative care and 30.3% for other reasons. Primary endpoint: consumption of fentanyl and midazolam in the 72 hours following the onset of study medication (main observation period) in the overall study population. The confirmatory analysis of the overall population showed no difference in the consumption of fentanyl and midazolam. Explorative age-stratified analysis demonstrated that in stratum I (n = 112) the clonidine group had a significantly lower consumption of fentanyl (clonidine: 2.1 ± 1.8 μg/kg/hr, placebo: 3.2 ± 3.1 μg/kg/hr; p = 0.032) and midazolam (clonidine: 113.0 ± 100.1 μg/kg/hr, placebo: 180.2 ± 204.0 μg/kg/hr; p = 0.030). Strata II (n = 43) and III (n = 46) showed no statistical difference. Sedation and withdrawal-scores were significantly lower in the clonidine group of stratum I (p < 0.001). Frequency of severe adverse events did not differ between groups.
Conclusions:
Clonidine 1 μg/kg/hr in ventilated newborns reduced fentanyl and midazolam demand with deeper levels of analgesia and sedation without substantial side effects. This was not demonstrated in older infants, possibly due to lower clonidine serum levels.
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