[Between wish and reality: more efficiency through increased outpatient procedures in paediatric urology]. / Zwischen Wunsch und Wirklichkeit: Mehr Effizienz durch Ambulantisierung von Eingriffen in der Kinderurologie.

The "outpatientisation" of procedures is gaining more and more interest. According to a report published by the German research institute IGES, more than 2000 procedures will be included in the catalogue for outpatient surgery in the future. This also means a significant increase in the number of procedures that can be performed on an outpatient basis in the field of (paediatric) urology. However, the feasibility, especially in paediatric urology, depends on many specific personnel, organisational and structural conditions.

Delayed primary closure of bladder exstrophy without osteotomy: 12 year experience in a safe and gentle alternative to neonatal surgery.

BACKGROUND: Successful primary closure of bladder exstrophy is of utmost importance for bladder capacity and urinary continence. We evaluated our concept of delayed primary closure that challenges the role of neonatal surgery, pelvic osteotomy, and perioperative pain management. MATERIAL AND METHODS: We reviewed the medical records of patients with classic bladder exstrophy (CBE) who had undergone delayed primary closure without osteotomy at our institution between January 2008 and May 2020. Data to be analyzed included patient demographics, intraoperative pelvic laxity, blood transfusion, postoperative ventilation time, requirement of pain medication, time to full feeds, length of ICU stay, postoperative complications, and total hospital stay. RESULTS: 66 patients (44 boys) met the inclusion criteria. Mean age at surgery was 64.8 days (SD±24.7). Pelvic approximation < 5 mm was possible in 66 (100%) patients. Blood transfusion was required by 31 (47%) patients. 14 (21.2%) patients needed postoperative ventilation for a mean time of 2.7 h. 45 (68.2%) children required intravenous opioids in addition to an epidural catheter. Oral feeding started on average 17.6 h after surgery. Mean ICU stay was 1.3 day. The initial success rate of delayed closure was 93.9%. None of the patients had bladder dehiscence. Girls developed more often minor postoperative complications than boys (m/f: 12 [27.3%] vs. 8 [36.4%]. Mean overall time of hospitalization was 19 days (13-34 d). CONCLUSION: Delayed primary closure of CBE without osteotomy but with continuous epidural blockage is a safe and promising procedure that has crucial advantages in the pre- and postoperative management of CBE. LEVEL OF EVIDENCE: Level III.

Impact of clear fluid fasting on pulmonary aspiration in children undergoing general anesthesia: Results of the German prospective multicenter observational (NiKs) study.

BACKGROUND: A preliminary national audit of real fasting times including 3324 children showed that the fasting times for clear fluids and light meals were frequently shorter than recommended in current guidelines, but the sample size was too small for subgroup analyses. AIMS: Therefore, the primary aim of this extended study with more participating centers and a larger sample size was to determine whether shortened fasting times for clear fluids or light meals have an impact on the incidence of regurgitation or pulmonary aspiration during general anesthesia in children. The secondary aim was to evaluate the impact of age, emergent status, ASA classification, induction method, airway management or surgical procedure. METHODS: After the Ethics Committee's approval, at least more than 10 000 children in total were planned to be enrolled for this analysis. Patient demographics, real fasting times, anesthetic and surgical procedures, and occurrence of target adverse events defined as regurgitation or pulmonary aspiration were documented using a standardized case report form. RESULTS: At fifteen pediatric centers, 12 093 children scheduled for surgery or interventional procedures were included between October 2018 and December 2019. Fasting times were shorter than recommended in current guidelines for large meals in 2.5%, for light meals in 22.4%, for formula milk in 5.3%, for breastmilk in 10.9%, and for clear fluids in 39.2%. Thirty-one cases (0.26%) of regurgitation, ten cases (0.08%) of suspected pulmonary aspiration, and four cases (0.03%) of confirmed pulmonary aspiration were reported, and all of them recovered quickly without any consequences. Fasting times for clear fluids shortened from 2 hours to 1 hour did not affect the incidence of adverse events (upper limit 95% CI 0.08%). The sample size of the cohort with fasting times for light meals shorter than 6 hours was too small for a subgroup analysis. An age between one and 3 years (odds ratio 2.7,95% CI 1.3 to 5.8%; P < .01) and emergent procedures (odds ratio 2.8,95% CI 1.4 to 5.7;P < .01) increased the incidence of adverse events, whereas ASA classification, induction method, or surgical procedure had no influence. The clear fluid fasting times were shortest under 6/4/0 as compared to 6/4/1 and 6/4/2 fasting regimens, all with an incidence of 0.3% for adverse events. CONCLUSION: This study shows that a clear fluid fasting time shortened from 2 hours to 1 hour does not affect the incidence of regurgitation or pulmonary aspiration, that an age between one and 3 years and emergent status increase the incidence of regurgitation or pulmonary aspiration, and that pulmonary aspiration followed by postoperative respiratory distress is rare and usually shows a quick recovery.

Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year.

Background Due to possible serious adverse drug reactions (ADRs), the use of metamizole for postoperative pain therapy in infants is a subject of debate. Safety studies with large sample sizes are missing. Aim This prospective multicenter observational study was conducted to evaluate the use of metamizole in infants younger than 1 year undergoing surgery with a particular focus on possible serious ADRs (e.g., hemodynamic, anaphylactic or respiratory reactions, and agranulocytosis). Methods Infants aged up to 1 year (American Society of Anesthesiologists [ASA] I-III) receiving a single dose of metamizole for postoperative pain therapy were enrolled. Patient demographics, main and secondary diagnosis, surgical procedures performed, metamizole dose, hemodynamic data, use of other analgesics and regional blocks, results of pain measurement, and incidence of ADRs were documented using a standardized case report form. Results A total of 316 infants observed at five pediatric centers were included for analysis (age 4.4 ± 3.7 [0.06-12] months). Mean metamizole dose was 17.8 ± 3.1 (9.2-29.8) mg·kg-1. Mean arterial pressure (MAP) remained stable during metamizole infusion (MAP before infusion 45 ± 9.5 [25-95] and after infusion 45 ± 9.2 [25-99] mm Hg). Erythema was observed in one patient (ADRs total: 0.3%, 95% confidence interval: 0.27-0.32). No respiratory adverse events directly related to the metamizole administration and no clinical signs of agranulocytosis were reported. Conclusion Single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 300 infants younger than 1 year. The statistical probability of serious ADRs (e.g., hemodynamic, anaphylactic or respiratory reactions) was lower than 1%. The sample size and follow-up were not sufficient to detect agranulocytosis.

Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study.

BACKGROUND: Due to possible serious adverse drug reactions (ADRs), the use of metamizole for postoperative pain therapy in children is a subject of debate. Safety studies with large sample sizes have not been published as yet. OBJECTIVE: The aim of this study was to evaluate the use of metamizole in children aged up to 6 years undergoing surgery with a particular focus on serious ADRs such as haemodynamic, anaphylactic or respiratory reactions and agranulocytosis. DESIGN: A multicentre, prospective, noninterventional, observational postauthorisation safety study (PASS). SETTING: The study was conducted in six different paediatric centres from September 2013 to September 2014. PATIENTS: One thousand one hundred and seventy-seven children aged up to six years (American Society of Anesthesiologists' physical status class I to III) receiving a single dose of metamizole for postoperative pain therapy were enrolled. MAIN OUTCOME MEASURES: Patient demographics, main and secondary diagnoses, surgical procedures performed, metamizole dose, haemodynamic data, use of other analgesics and regional blocks, results of pain measurement (Children and Infants Postoperative Pain Scale, ChIPPS) and ADR incidence were documented using a standardised case report form. RESULTS: Of the 1177 children observed at six paediatric centres, 1145 were included for analysis [age 35.8 ± 18.1 (0.1 to 72) months]. The mean metamizole dose was 17.3 ± 2.9 (8.3 to 29.4) mg kg(-1). Mean arterial pressure (MAP) remained stable during metamizole infusion [baseline 55.7 ± 1.3 (25 to 98) and after infusion 56.6 ± 11.3 (25 to 99) mmHg; P < 0.01]. Pruritus, swelling and exanthema were observed in one patient each (total 0.3%). No respiratory adverse events directly related to the metamizole administration and no clinical signs of agranulocytosis were reported. All data are mean ± SD (range). CONCLUSION: Single intravenous doses of metamizole used for the prevention or treatment of postoperative pain were well tolerated in more than 1000 children aged up to 6 years. The probability of serious ADRs (haemodynamic, anaphylactic or respiratory reactions) is lower than 0.3%. The sample size and follow-up was not sufficient to detect episodes of agranulocytosis.