Journal of magnetic resonance imaging : JMRI · 2008
Multicenter trial: comparison of two different formulations and application systems of low-dose nasal midazolam for routine magnetic resonance imaging of claustrophobic patients.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Tschirch Frank T C, Suter Katja, Froehlich Johannes M, Studler Ueli, Nidecker Andreas, Eckhardt Boris, Beranek-Chiu Jan, Surber Christian, Weishaupt Dominik
Аннотация
PURPOSE: To prospectively assess and compare two formulations and methods of administration of low-dose nasal midazolam for the treatment of claustrophobic patients undergoing magnetic resonance imaging (MRI) as part of a multicenter Phase III trial.
MATERIALS AND METHODS: In all, 108 consecutive adult claustrophobic patients were randomly assigned to one of two treatment groups (multidose group: MDG, unit-dose group: UDG). MDG encompassed 55 patients who received intranasally a 0.5% midazolam formulation into each nostril (total dose, 1.0 mg), whereas the 53 patients in UDG received a 1% midazolam formulation into only one nostril (total dose, 1.0 mg). This initial dose could be repeated once. Patient tolerance and anxiety were assessed using a questionnaire and a visual analog scale immediately before and after MRI. Image quality was evaluated using a five-point scale.
RESULTS: In all, 53/55 MR examinations (96%) with MDG and 52/53 (98%) with UDG were completed successfully. The dose of 1 mg had to be repeated significantly less often in UDG compared to MDG (4/53, 8% vs. 13/55, 24%; P = 0.003). The image quality of all MR examinations was rated good to excellent, and slightly better in UDG (P = 0.045).
CONCLUSION: Nasally applied low-dose midazolam is a patient-friendly solution to facilitate MRI of claustrophobic patients. The nasal spray of UDG is superior to that of MDG with a necessity of additional dosing.
MATERIALS AND METHODS: In all, 108 consecutive adult claustrophobic patients were randomly assigned to one of two treatment groups (multidose group: MDG, unit-dose group: UDG). MDG encompassed 55 patients who received intranasally a 0.5% midazolam formulation into each nostril (total dose, 1.0 mg), whereas the 53 patients in UDG received a 1% midazolam formulation into only one nostril (total dose, 1.0 mg). This initial dose could be repeated once. Patient tolerance and anxiety were assessed using a questionnaire and a visual analog scale immediately before and after MRI. Image quality was evaluated using a five-point scale.
RESULTS: In all, 53/55 MR examinations (96%) with MDG and 52/53 (98%) with UDG were completed successfully. The dose of 1 mg had to be repeated significantly less often in UDG compared to MDG (4/53, 8% vs. 13/55, 24%; P = 0.003). The image quality of all MR examinations was rated good to excellent, and slightly better in UDG (P = 0.045).
CONCLUSION: Nasally applied low-dose midazolam is a patient-friendly solution to facilitate MRI of claustrophobic patients. The nasal spray of UDG is superior to that of MDG with a necessity of additional dosing.