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BACKGROUND Recent upper respiratory tract infection (URI) is a risk factor for the occurrence of peri-operative respiratory adverse events (PRAE). This risk may be higher in children with congenital heart disease (CHD), particularly in those undergoing interventional cardiac catheterisation. It is therefore essential to adapt the anaesthetic strategy in these children to prevent from the occurrence of PRAE. OBJECTIVE To determine whether intranasal dexmedetomidine (DEX) premedication can reduce the incidence of PRAE in children with recent URI undergoing interventional cardiac catheterisation. DESIGN Randomised controlled trial. SETTING Single-centre study based at a tertiary care centre in Shanghai, China. PATIENTS A total of 134 children with CHD aged 0 to 16 years with recent URI undergoing interventional cardiac catheterisation. INTERVENTIONS Children were randomised to receive either intranasal DEX 1.5 μg kg (DEX group) or intranasal saline (Placebo group) 30 to 45 min before anaesthesia induction. MAIN OUTCOME MEASURES The incidence of PRAE. RESULTS Intranasal DEX significantly reduced the incidence of PRAE (P = 0.001), particularly oxygen desaturation (P = 0.012). Most PRAE were observed during the emergence phase. The incidence of PRAE was comparable among the three types of left-right shunt CHD children in both groups. In children aged less than 3 years, the incidence of PRAE was significantly lower in the DEX group (P = 0.003). In contrast, the incidence of PRAE was comparable between the two groups in children aged at least 3 years. No differences in the incidence of emergence agitation, fever and vomiting between the two groups were noted. CONCLUSION Administration of intranasal DEX 1.5 μg kg 30 to 45 min before induction led to a reduction in the incidence of PRAE in children aged less than 3 years with recent URI undergoing interventional cardiac catheterisation. TRIAL REGISTRATION chictr.org.cn identifier: ChiCTR-RRC-17012519.