Safety profile during initiation of propranolol for treatment of infantile haemangiomas in an ambulatory day-care hospitalization setting

Background: Propranolol is the mainstay of treatment for infantile haemangioma. Despite its good safety profile, it is not risk-free. Guidelines for propranolol initiation and monitoring have been suggested, but protocols vary among practitioners. Objective: This study sought to assess the prevalence of adverse events and clinically significant fluctuations in haemodynamic parameters in children with infantile haemangioma during initiation of treatment with propranolol in a day-hospitalization setting. Methods: Children with infantile haemangioma treated with propranolol in a day-hospitalization department of a tertiary paediatric medical centre in 2008–2014 were identified retrospectively. The pretreatment evaluation included clinical examination by a paediatric dermatologist and electrocardiography, echocardiography and clinical examination by a paediatric cardiologist. The propranolol dosage was escalated from 0.5 mg/kg/day to 2 mg/kg/day, divided into three doses/day, over 3 days. Heart rate, blood pressure and blood glucose level were measured before treatment onset and 60 min after the first two doses each day. The third dose was given at home. Results: The cohort included 220 children aged 1 month to 5 years. No severe treatment-related adverse events were documented; 27 patients had minor side-effects. There was a significant decrease in heart rate each day after the first two doses (P < 0.001), and in systolic blood pressure, on day 2 (1 mg/kg/day) after the first dose (P = 0.01). Blood glucose level remained stable. The haemodynamic changes were clinically asymptomatic and did not require intervention. Conclusions: Propranolol treatment (2 mg/kg/day in three doses) for infantile haemangioma is well tolerated and safe and may be administered and monitored in an ambulatory setting.