Adverse events after protamine administration following cardiopulmonary bypass in infants and children

FACE†*Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University ofPennsylvania School of Medicine, Philadelphia, Pennsylvania; and †Division of Cardiothoracic Anesthesiology,Department of Anesthesiology & Critical Care, The Children’s Hospital of Philadelphia, University of Pennsylvania,Philadelphia, PennsylvaniaWe performed this study to determine the incidence ofand risk factors for adverse events (AEs) in infants andchildren after the IV administration of protamine aftercardiopulmonary bypass. In a retrospective cohortstudy,allrelevantanesthesiarecordsfroma3-yrperiodwere examined to identify AEs after protamine. TheAEs were then grouped into three categories by apply-ing increasingly strict criteria. Among 1249 anesthesiarecords,therewerenodocumentedepisodesofisolatedorhypotension-associatedright-sidedcardiacfailureoracute pulmonary dysfunction. The incidence of sys-temic hypotension after protamine was between 1.76%(95% confidence interval [CI], 1.11%–2.65%) and 2.88%(95% CI, 2.03%–3.97%), depending on the strictness ofcase definition. To identify risk factors, we performed anestedcase-controlstudyinwhichunmatchedcontrolswere randomly selected from the parent cohort at a 4:1ratio to cases. Cases of hypotension after protaminewere more likely during operations on girls (odds ratio[OR], 6.47; 95% CI, 1.66–32.8), after larger doses of pro-tamine (OR, 1.88; 95% CI, 1.03–3.63), or after smallerdoses of heparin (OR, 0.49; 95% CI, 0.17–0.67).(Anesth Analg 2003;97:383–9)