Actively Recruiting
Administration of Intranasal Midazolam for Anxiety in Palliative Care
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-09-10
36
Participants Needed
5
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Administration of Intranasal Midazolam for Anxiety in Palliative Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult palliative care patients aged 18 years or older hospitalized at one of the study sites
- Self-reported acute anxiety with clinical indication for intranasal midazolam prescribed by attending physician
- Patient willing and able to provide written informed consent
- Signed informed consent documented
- Patient willing and able to complete anxiety assessments
- For nested pharmacokinetic analysis: patients with available central or peripheral venous access and willing to provide blood samples
You will not qualify if you...
- Intranasal midazolam prescribed for seizures
- Midazolam used continuously for sedation by any route
- History of allergy or hypersensitivity to midazolam
- History of benzodiazepine-related paradoxical reaction to midazolam
- Acute narrow-angle glaucoma
- Impaired nasal absorption (e.g., nasogastric tube, nasal obstruction, nasal polyps)
- Intranasal midazolam administered within 24 hours before study enrollment
- Less than 24 hours between general consent and planned midazolam administration
- Use of strong CYP3A4 inducers or inhibitors
- Started strong opioid therapy within past 5 days
- Use of other CNS depressants causing significant sedation
- Inability to follow study procedures due to language issues, dementia, or other reasons
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Palliativzentrum Bethesda Spital
Basel, Canton of Basel-City, Switzerland, 4052
Actively Recruiting
2
Inselspital, Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
3
Universitäres Zentrum für Palliative Care (UZP)
Bern, Switzerland
Actively Recruiting
4
Zentrum für Palliative Care, Stadtspital Zürich
Zurich, Switzerland, 8037
Actively Recruiting
5
Kompetenzzentrum Palliative Care, Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
M
Manuel Haschke, MD
CONTACT
U
Ursina Wernli, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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