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PEDIATRIC ANESTHESIA

Adverse Events After Protamine Administration Following Cardiopulmonary Bypass in Infants and Children

Harry A. Seifert, MD MSCE^*,, David R. Jobes, MD, Thomas Ten Have, PhD MPH^*, Stephen E. Kimmel, MD MSCE, FACC^*, Lisa M. Montenegro, MD, James M. Steven, MD SM, FAAP, Susan C. Nicolson, MD, and Brian L. Strom, MD MPH, FACP, FACE

*Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania 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, Pennsylvania

Address correspondence to Harry A. Seifert, MD, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, MC-4340, 1250 S. Collegeville Rd., Collegeville, PA 19426. Address e-mail to harryaseifert{at}comcast.net Reprints will not be available from the author.

We performed this study to determine the incidence of and risk factors for adverse events (AEs) in infants and children after the IV administration of protamine after cardiopulmonary bypass. In a retrospective cohort study, all relevant anesthesia records from a 3-yr period were examined to identify AEs after protamine. The AEs were then grouped into three categories by applying increasingly strict criteria. Among 1249 anesthesia records, there were no documented episodes of isolated or hypotension-associated right-sided cardiac failure or acute pulmonary dysfunction. The incidence of systemic 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 of case definition. To identify risk factors, we performed a nested case-control study in which unmatched controls were randomly selected from the parent cohort at a 4:1 ratio to cases. Cases of hypotension after protamine were more likely during operations on girls (odds ratio [OR], 6.47; 95% CI, 1.66–32.8), after larger doses of protamine (OR, 1.88; 95% CI, 1.03–3.63), or after smaller doses of heparin (OR, 0.49; 95% CI, 0.17–0.67).

IMPLICATIONS: Systemic hypotension after protamine administration occurred in 1.76%–2.88% of pediatric patients having cardiac surgery. Female sex, larger protamine dose, and smaller heparin dose were each associated with increased risk. The development of protamine alternatives or prophylactic therapies may be useful for reducing the frequency of these events.

Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999