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J Thorac Cardiovasc Surg 2008;136:321-328
© 2008 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

The safety, efficacy, and pharmacokinetics of esmolol for blood pressure control immediately after repair of coarctation of the aorta in infants and children: A multicenter, double-blind, randomized trial

^a Children's Hospital of Philadelphia, Philadelphia, Pa
^b Los Angeles Children's Hospital, Los Angeles, Calif
^c Children's Memorial Hospital, Chicago, Ill
^d Children's Hospital of Boston, Boston, Mass
^e Wisconsin Children's Hospital, Milwaukee, Wis
^f Cleveland Clinic Foundation, Cleveland, Ohio
^g Baxter Healthcare, New Providence, NJ

Received for publication August 16, 2007; revisions received September 5, 2007; ^_* Address for reprints: Sarah Tabbutt, MD, PhD, Cardiac Intensive Care Unit, the Children's Hospital of Philadelphia, 34th Street and Civic Center Blvd, Philadelphia, PA 19104. (Email: tabbutt{at}email.chop.edu).

Objectives: Blood pressure control is important after repair of coarctation of the aorta. We report the first prospective multi-institutional trial addressing the safety and efficacy of esmolol after repair of coarctation of the aorta in infants and children.

Methods: The primary objective of this phase IIIb, multicenter, double-blind, randomized, dose-ranging trial was the efficacy of esmolol to control hypertension. Candidates included subjects younger than 6 years and weighing 2.5 kg or more who underwent surgical intervention for coarctation of the aorta and required therapy for systemic hypertension. One hundred sixteen subjects received esmolol: 36 received a low dose (125 µg/kg), 43 received a medium dose (250 µg/kg), and 37 received a high dose (500 µg/kg). The primary outcomes were the change in systolic blood pressure and the need for additional antihypertensive rescue medication 5 minutes after the initiation of esmolol.

Results: All dose groups showed a significant decrease from baseline in systolic blood pressure (–9.6 ± 16.3 mm Hg, P < .001). There were no differences in systolic blood pressure response at 5 minutes between dose groups (high, medium, or low) or age groups. The need for rescue medication at 5 minutes was not different between dose groups. All dose groups showed similar incidences of adverse events. There were no serious adverse events.

Discussion: Esmolol can be administered safely to patients younger than 6 years after repair of coarctation of the aorta. In the dose range of 125 to 500 µg/kg, esmolol significantly decreased systolic blood pressure.

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				S. Tabbutt, S. C. Nicolson, T. E. Dominguez, W. Wells, C. L. Backer, J. S. Tweddell, P. Bokesch, and M. Schreiner Perioperative course in 118 infants and children undergoing coarctation repair via a thoracotomy: A prospective, multicenter experience. J. Thorac. Cardiovasc. Surg., November 1, 2008; 136(5): 1229 - 1236. [Abstract] [Full Text] [PDF]