gms | German Medical Science

Amiodarone is a potent substance to successfully suppress episodes of tachycardia, syncope or sudden cardiac death. In the treatment of dysrhythmias in the elderly amiodarone is used for decades and is increasingly prescribed for patients with ventricular and supraventricular tachyarrhythmias. However, amiodarone treatment carries a risk of potentially serious pulmonary, cardiac, hepatic, thyroid, ocular, peripheral neurological and cutaneous (photosensitivity) adverse effects. The average plasma elimination half-life of amiodarone is about 50 days. Life threatening dysrhythmias do also occur in the peadiatric age group. A possible treatment is amiodarone medication as a last choice option. Meanwhile cardiologists, pharmacologists and others expect similar potential adverse effects in children during the course of the treatment with amiodarone, pediatric cardiologist’s viewpoint is that adverse effects in children are rare within the typical precription doses in successful treatment. However, there is no study available proving a different behavior of amiodarone in children. A multi centre serial observation study on amiodarone in children is planed using the networking facilities of the Cologne Centre for Clinical Studies, which is actually performing the first randomized double blind multi centre study on pharmacologic treatment in children, the clonidine study. Study design is a prospective observation of amiodarone treatment in a subset of more than 20 centres caring for dysrhythmias in childhood. Indication for amiodarone as a last choice drug is irresponsiveness to treatment with common antiarrhythmic drugs in the care of patients with life threatening tachycardias. Inclusion criteria, effect of treatment as well as potential adverse effects will be documented in a data base. After a five year interval the hypothesis of whether or not side effects occur less in children will be evaluated.