Anxiety Clinical Trial - Administration of Intranasal Midazolam for

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms