Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...
Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...
Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...
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7. Project III: <strong>Transmucosal</strong> nasal delivery <strong>of</strong> low-dose midazolam – evaluation <strong>of</strong> two preparations for procedural anxiolysis<br />
Patients and study design<br />
Enrollment<br />
Medication<br />
and MRI proceedings<br />
Evaluation<br />
Patients scheduled for MRI<br />
desiring anxiolysis because<br />
<strong>of</strong> general anxiety and/or claustrophobia<br />
Information<br />
Written consent<br />
Inclusion and exclusion criteria<br />
Treatment (MD)<br />
1mg midazolam nasal<br />
+ 1mg<br />
Randomization<br />
VAS before<br />
MRI examination<br />
VAS after<br />
comparator (UD)<br />
1mg midazolam nasal<br />
Interview after MRI examination<br />
Assessment <strong>of</strong> radiologic technician<br />
Image quality<br />
+ 1mg<br />
Figure 7-1: Study design <strong>of</strong> multicenter trial with<br />
nasal low-dose midazolam. Anxious and/or<br />
claustrophobic patients, scheduled for MRI<br />
examinations at the study centers (A, B, C, and<br />
D), were invited to participate in this multicenter<br />
trial with nasal low-dose midazolam. MD:<br />
multidose nasal spray (treatment), UD: unit dose<br />
nasal spray (comparator).<br />
Patients, scheduled for MRI examinations at<br />
the study centers and desiring anxiolysis,<br />
because <strong>of</strong> general anxiety and/or<br />
claustrophobia, were invited to participate in<br />
this clinical trial with nasal low-dose<br />
midazolam. Radiologists conclusively informed<br />
the interested patients and handed out written<br />
information about the clinical study protocol.<br />
Before enrollment, patients gave written<br />
consent. Figure 7-1 displays the study design<br />
<strong>of</strong> the multicenter study with nasal low-dose<br />
midazolam.<br />
Exclusion criteria were age