A randomized, controlled trial of aprotinin in neonates undergoing open-heart surgery.

BACKGROUND: Neonates undergoing open-heart surgery are especially at risk for massive bleeding and pronounced inflammation. The efficacy of aprotinin, a serine protease inhibitor, at ameliorating these adverse effects of cardiopulmonary bypass has not been clearly demonstrated in neonates. METHODS: Term neonates were enrolled and randomly assigned in a blinded fashion to receive saline (group P, placebo) or high-dose aprotinin (group A). Intraoperative management was standardized: surgeon, anesthesia, cardiopulmonary bypass and hemostasis therapy. Patients were admitted postoperatively to a pediatric cardiac intensive care unit. Primary outcome measure of efficacy was duration of the postoperative mechanical ventilation. Secondary outcome measures were total volume and units of blood products transfused intraoperatively and for 24 h after surgery, duration of chest tube in situ, and intensive care and hospital stays after surgery. RESULTS: Twenty-six neonates were enrolled; 13 received aprotinin and 13 received placebo. The study was halted prematurely because of US Food and Drug Administration's concerns about aprotinin's safety. Baseline patient, surgery and cardiopulmonary bypass characteristics were similar between groups. No outcome variables differed between groups (P > 0.05). Duration of postoperative ventilation was 115 +/- 139 h (group A); 126 +/- 82 h (group P); P = 0.29, and total blood product exposure was 8.2 +/- 2.6 U (group A); 8.8 +/- 1.4 U (group P); P = 0.1. Postoperative blood creatinine values did not differ between groups. In-hospital mortality rate was 4%. CONCLUSIONS: Aprotinin was not shown to be efficacious in neonates undergoing open-heart surgery. It is unclear whether adult aprotinin safety data are relevant to neonates undergoing open-heart surgery.

An analysis of factors influencing postanesthesia recovery after pediatric ambulatory tonsillectomy and adenoidectomy.

BACKGROUND: Many factors contribute to prolonged length of stay (LOS) for pediatric patients in the postanesthesia care unit (PACU). We designed this prospective study to identify the pre- and postoperative factors that prolong LOS. METHODS: We studied 166 children, aged 1-18 yr, who underwent tonsillectomy and adenoidectomy or tonsillectomy and adenoidectomy, and bilateral myringotomy with tube insertion under general anesthesia. The primary outcome measure was the time spent in the PACU until predetermined discharge criteria were met. RESULTS: The number of episodes of postoperative nausea and vomiting, patient age, and number of oxygen desaturations contributed significantly (P < 0.05) to prolonged LOS. Each episode of postoperative nausea and vomiting (P < 0.05) or oxygen desaturation to <95% (P < 0.05) increased the patient's LOS by 0.5 h. History of upper respiratory tract infection, emergence agitation, and parental anxiety did not significantly predict increased LOS. CONCLUSION: This investigation is the first composite view of LOS in pediatric patients. The significance of identifying patients at risk of prolonged LOS prior to anesthesia is of use not only in allocating PACU resource and staffing needs, but also for improving quality of care and ensuring a minimally traumatic anesthetic experience for our pediatric patients and their families.

Modified and conventional ultrafiltration during pediatric cardiac surgery: clinical outcomes compared.

OBJECTIVE: This prospective study compared clinical outcomes after heart surgery between three groups of infants with congenital heart disease. One group received dilutional conventional ultrafiltration (group D), another received modified ultrafiltration (group M), and a third group received both dilutional conventional and modified ultrafiltration (group B). We hypothesized that group B patients would have the best clinical outcome. METHODS: Children younger than 1 year undergoing heart surgery for biventricular repair by the same surgeon were randomly allocated to one of the three study groups. Patient management was standardized, and intensive care staff were blinded to group allocation. Primary outcome measure was duration of postoperative mechanical ventilation. Other outcome measures recorded included total blood products transfused, duration of chest tube in situ, chest tube output, and stays in intensive care and in the hospital. RESULTS: Sixty infants completed study protocol. Mean age and weight were as follows: group D (n = 19), 61 days, 4.3 kg; group M (n = 20), 64 days, 4.5 kg; and group B (n = 21), 86 days, 4.4 kg. Preoperative and intraoperative characteristics were similar between groups. Ultrafiltrate volumes obtained were 196 +/- 93 mL/kg in group D, 105 +/- 33 mL/kg in group M, and 261 +/- 113 mL/kg in group B. There were no significant differences between groups for any outcome variable. Technical difficulties prevented completion of modified ultrafiltration in 2 of 41 infants. CONCLUSION: There was no clinical advantage in combining conventional and modified ultrafiltration. Because clinical outcomes were similar across groups, relative risks of the ultrafiltration strategies may influence choice.