To assess the influence of an infusion of clonidine 1 μg/kg/hr on fentanyl and midazolam requirement in ventilated newborns and infants. Prospective, double-blind, randomized controlled multicenter trial. Controlled trials.com/ISRCTN77772144. Twenty-eight level 3 German PICUs/neonatal ICUs. Ventilated newborns and infants: stratum I (1-28 d), stratum II, (29-120 d), and stratum III (121 d to 2 yr). 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. 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. 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.
Propofol is not licensed for sedation in pediatric intensive care medicine mainly due to the risk of propofol infusion syndrome. Nevertheless, it is applied by many pediatric intensive care units. The aim of this national survey was to asses the current use of propofol in pediatric intensive care units in Germany. We performed a nationwide survey. The questionnaire assessed the intensive care unit type, patient numbers, dosing, duration, age and time limits, indications, side effects, and institutional protocols for propofol usage. Pediatric intensive care units in Germany. Questionnaire about routine use of propofol sent to 214 pediatric departments. None. One hundred ninety-four questionnaires (90.7%) were returned, ten had to be censored. The final analysis comprised 184 questionnaires (134 pediatric/neonatal intensive care units, 28 pediatric intensive care units, 22 neonatal intensive care units). Seventy-nine percent of intensive care units (n = 145 of 184) used propofol in children under the age of 16 yrs. Of these, 98% were for bolus application (n = 142 of 145), 78% for infusion ≥3 hrs (n = 113 of 145), and 33% for infusion >3 hrs (n = 48 of 145). A lower age limit was applied by 52% (n = 75 of 145) and a dose limit by 51% (n = 74 of 145). The median dose limit was 4 mg/kg/hr; 48% (n = 70 of 145) used 3 mg/kg/hr or less. A time limit was applied by 98% (n = 46 of 47), 70% (n = 33 of 47) used it for ≤24 hrs, and 30% (n = 15 of 47) for >24 hrs. difficult sedation (44%), postoperative ventilation (43%), and difficult extubation (30%). Seven cases of propofol infusion syndrome were reported by seven centers. This study shows that propofol is used off-license by many pediatric intensive care units in Ge. The majority of users has adopted tightly controlled regimens for propofol sedation, and limits the dose to ≤3–4 mg/kg/hr and the maximum application time to 24–48 hrs.
Background and Objectives: Pediatric extracorporeal membrane oxygenation (ECMO) support is often the ultimate therapy for neonatal and pediatric patients with congenital heart defects after cardiac surgery. The impact of lactate clearance in pediatric patients during ECMO therapy on outcomes has been analyzed. Materials andMethods: We retrospectively analyzed data from 41 pediatric vaECMO patients between January 2006 and December 2016. Blood lactate and lactate clearance have been recorded prior to ECMO implantation and 3, 6, 9 and 12 h after ECMO start. Receiver operating characteristic (ROC) analysis was used to identify cut-off levels for lactate clearance. Results: Lactate levels prior to ECMO therapy (9.8 mmol/L vs. 13.5 mmol/L; p = 0.07) and peak lactate levels during ECMO support (10.4 mmol/L vs. 14.7 mmol/L; p = 0.07) were similar between survivors and nonsurvivors. Areas under the curve (AUC) of lactate clearance at 3, 9 h and 12 h after ECMO start were significantly predictive for mortality (p = 0.017, p = 0.049 and p = 0.006, respectively). Cut-off values of lactate clearance were 3.8%, 51% and 56%. Duration of ECMO support and respiratory ventilation was significantly longer in survivors than in nonsurvivors (p = 0.01 and p < 0.001, respectively). Conclusions: Dynamic recording of lactate clearance after ECMO start is a valuable tool to assess outcomes and effectiveness of ECMO application. Poor lactate clearance during ECMO therapy in pediatric patients is a significant marker for higher mortality.