Administration of Intranasal Midazolam for Anxiety in Palliative Care — AIM Care  

Anxiety Clinical Trial

Official title: Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind, Randomized, Placebo-controlled Multicenter Exploratory Pilot Study With a Nested Pharmacokinetic Analysis

Status Not yet recruiting

Clinical Trial Summary

The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data.

Clinical Trial Description

30 patients (10 patients per study arm) will be enrolled. All patients hospitalized at the three study sites, which are prescribed intranasal midazolam in their as-needed drug regimen and who meet inclusion criteria, are eligible. Patients will be asked for consent at the time of prescription of midazolam by the attending physician. Patients who have provided consent and have been randomized to one of the arms will be included (block randomization). In a nested analysis, pharmacokinetic properties of all three doses will be analyzed in participants with available venous access. The primary outcome is the change in patient-reported levels of anxiety. Secondary outcomes include time until first requested additional dose, cumulative number of doses including time points of administration after the first application, oxygen saturation, heart rate, cortisol levels in oral fluid, levels of sedation on the Richmond Agitation Sedation Scale Palliative Version (RASS-PAL), and occurrence of adverse drug events. The primary and secondary outcomes will be assessed at baseline, i.e., immediately before the intervention (0 minutes) and 30 minutes after the intervention. Two of the secondary outcomes ('Time to first requested additional dose' and 'Cumulative number of doses over 24 hours') will be assessed starting 30 minutes after the intervention up to 24 hours after the intervention. In patients included in the nested pharmacokinetic analysis, basic pharmacokinetic parameters will additionally be assessed at 10 time points, starting at baseline (0 minutes) up to 240 minutes after the intervention. ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT06330584
• Study type: Interventional
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Manuel Haschke, MD
• Phone: +41 (0)31 632 67 93
• Email: manuel.haschke@insel.ch
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Completion date: October 31, 2024