PURPOSE: The aim of this prospective study was to evaluate and compare acute adverse reactions between contrast medium containing moderate and high concentrations of iodine in patients undergoing computed tomography (CT). MATERIALS AND METHODS: A total of 945 patients undergoing enhanced CT were randomly assigned to receive one of two doses of contrast medium. We then prospectively investigated the incidence of adverse reactions. Iopamidol was used as the contrast medium, with a high concentration of 370 mg I/ml and a moderate concentration of 300 mg I/ml. The frequency of adverse reactions, such as pain at the injection site and heat sensation, were determined. RESULTS:Acute adverse reactions were observed in 2.4% (11/458) of the moderate-concentration group compared to 3.11% (15/482) of the high-concentration group; there was no significant difference in incidence between the two groups. Most adverse reactions were mild, and there was no significant difference in severity. One patient in the high-concentration group was seen to have a moderate adverse reaction. No correlation existed between the incidence of adverse reactions and patient characteristics such as sex, age, weight, flow amount, and flow rate. The incidence of pain was not significantly different between the two groups. In contrast, the incidence of heat sensation was significantly higher in the high-concentration group. CONCLUSIONS: The incidence and severity of acute adverse reactions were not significantly different between the two groups, and there were no severe adverse reactions in either group.
RCT Entities:
PURPOSE: The aim of this prospective study was to evaluate and compare acute adverse reactions between contrast medium containing moderate and high concentrations of iodine in patients undergoing computed tomography (CT). MATERIALS AND METHODS: A total of 945 patients undergoing enhanced CT were randomly assigned to receive one of two doses of contrast medium. We then prospectively investigated the incidence of adverse reactions. Iopamidol was used as the contrast medium, with a high concentration of 370 mg I/ml and a moderate concentration of 300 mg I/ml. The frequency of adverse reactions, such as pain at the injection site and heat sensation, were determined. RESULTS: Acute adverse reactions were observed in 2.4% (11/458) of the moderate-concentration group compared to 3.11% (15/482) of the high-concentration group; there was no significant difference in incidence between the two groups. Most adverse reactions were mild, and there was no significant difference in severity. One patient in the high-concentration group was seen to have a moderate adverse reaction. No correlation existed between the incidence of adverse reactions and patient characteristics such as sex, age, weight, flow amount, and flow rate. The incidence of pain was not significantly different between the two groups. In contrast, the incidence of heat sensation was significantly higher in the high-concentration group. CONCLUSIONS: The incidence and severity of acute adverse reactions were not significantly different between the two groups, and there were no severe adverse reactions in either group.