Low-dose intranasal versus oral midazolam for routine body MRI of claustrophobic patients

Abstract

The purpose of this study was to assess prospectively the potential of low-dose intranasal midazolam compared to oral midazolam in claustrophobic patients undergoing routine body magnetic resonance imaging (MRI). Seventytwo adult claustrophobic patients referred for body MRI were randomly assigned to one of two treatment groups (TG1 and TG2). The 36 patients of TG1 received 7.5 mg midazolam orally 15 min before MRI, whereas the 36 patients of TG2 received one (or, if necessary, two) pumps of a midazolam nasal spray into each nostril immediately prior to MRI (in total, 1 or 2 mg). Patients' tolerance, anxiety and sedation were assessed using a questionnaire and a visual analogue scale immediately before and after MRI. Image quality was evaluated using a five-point-scale. In TG1, 18/36 MRI examinations (50%) had to be cancelled, the reduction of anxiety was insufficient in 12/18 remaining patients (67%). In TG2, 35/36 MRI examinations (97%) were completed successfully, without relevant adverse effects. MRI image quality was rated higher among patients of TG2 compared to TG1 (p<0.001). Low-dose intranasal midazolam is an effective and patientfriendly solution to overcome anxiety in claustrophobic patients in a broad spectrum of body MRI. Its anxiolytic effect is superior to that of the orally administrated form.

Multicenter trial: Comparison of two different formulations and application systems of low‐dose nasal midazolam for routine magnetic resonance imaging of claustrophobic patients

“…In our multicenter trial one of the formulations of the used midazolam sprays (ie, the multidose nasal spray) was similar to that used in the recent study of Tschirch et al (5). Two possible limitations of this multidose spray are, first, that administration of the spray has to be performed with the patient in an upright position, and second, this formulation is associated with a relatively high frequency of a temporary burning sensation after application.…”

“…We only used a VAS to quantify the severity of claustrophobia before and after MRI, and no psychometric test was made such as the Spielberger State-Trait Anxiety Inventory (STAI). However, other investigators also worked successfully using only the VAS (5,10). On the other hand, Hollenhorst et al (2) found similar results using both STAI and VAS, whereas Dantendorfer et al (11) could not find a correlation between values of STAI and the presence of motion artifacts.…”

“…A limited number of studies (2,4,5) have shown the potential of nasally administrated midazolam for reduction of anxiety-related claustrophobia in patients undergoing MR imaging. However, all these studies were single-center studies with a limited number of patients.…”

“…However, all these studies were single-center studies with a limited number of patients. In addition, the formulation recently described by Tschirch et al (5) had some limitations, including the fact that the spray had to be administered with the patient in an upright position and the relatively high frequency of a temporary burning sensation after application of the nasal spray. The purpose of this study was to prospectively assess the potential of the nasal application of midazolam in a multicenter Phase III trial and to compare two formulations and application forms of a low-dose (1 mg) midazolam nasal spray in claustrophobic patients undergoing routine MRI.…”

Scientific Exhibits

“…Our institution's current protocol is adequate and may be recommended to other MR examination centres and institutions. Future studies may investigate the route of midazolam administered (Tschirch FT, 2007) and may also consider a standard dose to assist inpatient studies where anxiety is anticipated.…”