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

Full text not available from this repository.

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:
CreatorsEmailORCIDORCID Put Code
Huenseler, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balling, GunterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roehlig, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blickheuser, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trieschmann, UweUNSPECIFIEDorcid.org/0000-0003-2529-9005UNSPECIFIED
Lieser, UllaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dohna-Schwake, ChristianUNSPECIFIEDorcid.org/0000-0001-8973-5406UNSPECIFIED
Gebauer, CorinnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moeller, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hering, FritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoehn, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schubert, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hentschel, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huth, Ralf G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wassmer, GernotUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahn, MoritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harnischmacher, UrsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Behr, JulieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roth, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
NEONATAL ABSTINENCE SYNDROME; CRITICALLY-ILL CHILDREN; INTENSIVE-CARE-UNIT; ORAL CLONIDINE; INTRAVENOUS CLONIDINE; PEDIATRIC-PATIENTS; MECHANICAL VENTILATION; POSTOPERATIVE PAIN; NORWOOD PROCEDURE; SEDATIONMultiple languages
Critical Care Medicine; PediatricsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/43463

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item