Universität zu Köln

Huenseler, Christoph, Balling, Gunter, Roehlig, Christoph, Blickheuser, Rainer, Trieschmann, Uwe ORCID: 0000-0003-2529-9005, Lieser, Ulla, Dohna-Schwake, Christian ORCID: 0000-0001-8973-5406, Gebauer, Corinna, Moeller, Oliver, Hering, Fritz, Hoehn, Thomas, Schubert, Stephan, Hentschel, Roland, Huth, Ralf G., Mueller, Andreas, Mueller, Carsten, Wassmer, Gernot, Hahn, Moritz, Harnischmacher, Urs, Behr, Julie and Roth, Bernhard (2014). Continuous Infusion of Clonidine in Ventilated Newborns and Infants: A Randomized Controlled Trial. Pediatr. Crit. Care Med., 15 (6). S. 511 - 523. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1947-3893

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Abstract

Objectives: To assess the influence of an infusion of clonidine 1 mu g/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 mu g/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 mu g/kg/hr, placebo: 3.2 +/- 3.1 mu g/kg/hr; p = 0.032) and midazolam (clonidine: 113.0 +/- 100.1 mu g/kg/hr, placebo: 180.2 +/- 204.0 mu g/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 mu g/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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Huenseler, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Balling, Gunter UNSPECIFIED UNSPECIFIED UNSPECIFIED Roehlig, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Blickheuser, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Trieschmann, Uwe UNSPECIFIED orcid.org/0000-0003-2529-9005 UNSPECIFIED Lieser, Ulla UNSPECIFIED UNSPECIFIED UNSPECIFIED Dohna-Schwake, Christian UNSPECIFIED orcid.org/0000-0001-8973-5406 UNSPECIFIED Gebauer, Corinna UNSPECIFIED UNSPECIFIED UNSPECIFIED Moeller, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Hering, Fritz UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoehn, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Schubert, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hentschel, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Huth, Ralf G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Wassmer, Gernot UNSPECIFIED UNSPECIFIED UNSPECIFIED Hahn, Moritz UNSPECIFIED UNSPECIFIED UNSPECIFIED Harnischmacher, Urs UNSPECIFIED UNSPECIFIED UNSPECIFIED Behr, Julie UNSPECIFIED UNSPECIFIED UNSPECIFIED Roth, Bernhard UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-434633
DOI:	10.1097/PCC.0000000000000151
Journal or Publication Title:	Pediatr. Crit. Care Med.
Volume:	15
Number:	6
Page Range:	S. 511 - 523
Date:	2014
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1947-3893
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NEONATAL ABSTINENCE SYNDROME; CRITICALLY-ILL CHILDREN; INTENSIVE-CARE-UNIT; ORAL CLONIDINE; INTRAVENOUS CLONIDINE; PEDIATRIC-PATIENTS; MECHANICAL VENTILATION; POSTOPERATIVE PAIN; NORWOOD PROCEDURE; SEDATION Multiple languages Critical Care Medicine; Pediatrics Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43463