ABSTRACT
<p><b>BACKGROUND</b>Amiodarone is a useful antiarrhythmic drug. Phlebitis, caused by intravenous amiodarone, is common in patients in coronary care units (CCUs).</p><p><b>OBJECTIVE</b>The aim of this study was to evaluate the effect of topical chamomile on the incidence of phlebitis due to the administration of an amiodarone infusion into the peripheral vein.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>This was a randomized, double-blind clinical trial, conducted on 40 patients (n = 20 per group) in two groups-an intervention group (chamomile ointment) and a control group (lanoline, as a placebo), hospitalized in the CCUs and undergoing an amiodarone infusion into the peripheral vein over 24 h. Following the cannulation and commencement of the infusion, placebo or chamomile ointment was rubbed in, up to 10 cm superior to the catheter and repeated every eight hours for three days. The cannula site was then assessed based on the phlebitis checklist.</p><p><b>MAIN OUTCOME MEASURES</b>The incidence and time of occurrence of phlebitis, relative risk, severity of phlebitis were the main outcome measures.</p><p><b>RESULTS</b>Nineteen patients (19/20) in the control group had phlebitis on the first day of the study and one patient (20/20) on the second day. In the intervention group, phlebitis occurred in 13 cases (13/20) on the first day and another two (2/7) was found on the second day. The incidence of phlebitis was significantly different between two groups (P = 0.023). The cumulative incidence of phlebitis in the intervention group (15/20) is significantly later and lower than that in the control group (20/20) during two days (P = 0.008). Two patients in the intervention group did not develop phlebitis at all during the 3-day study. Also, the relative risk of phlebitis in the two groups was 0.68 (P = 0.008 5). A significant difference was not observed with regard to phlebitis severity in both groups.</p><p><b>CONCLUSION</b>It seems that phlebitis occurred to a lesser extent and at a later time frame in the intervention group compared to control group. Topical chamomile may be effective in decreasing the incidence of phlebitis due to an amiodarone infusion.</p><p><b>TRIAL REGISTRATION</b>This protocol was registered in the Iranian Registry of Clinical Trials (IRCT2014042017361N1).</p>