Actively Recruiting
Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind, Randomized, Placebo-controlled Multicenter Exploratory Pilot Study with Nested Pharmacokinetic Analysis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-09-10
36
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of different doses of intranasal midazolam to treat acute anxiety in adult palliative care patients. This double-blind, randomized, placebo-controlled exploratory pilot study aims to provide pharmacokinetic and pharmacodynamic data to better understand how midazolam works in this setting. The study enrolls hospitalized patients who are prescribed intranasal midazolam as needed and meet specific inclusion criteria. The study includes three groups: a placebo group receiving no active midazolam, a group receiving 0.9 mg total dose, and a group receiving 1.8 mg total dose of midazolam through a nasal spray. Each participant receives one spray in each nostril. A nested analysis will examine pharmacokinetic parameters in patients with venous access by collecting blood samples at multiple time points up to 240 minutes after administration. Participants will be assessed before treatment and 30 minutes after for anxiety levels, sedation, oxygen saturation, heart rate, and cortisol in oral fluid. Additional measures such as time to first additional dose, cumulative doses over 24 hours, and adverse events will be tracked up to 24 hours post-treatment. Patients in the pharmacokinetic subgroup will have blood samples collected for detailed drug concentration analysis. The study plans to enroll 36 patients, with 12 in each group, and will monitor safety and response throughout the study period.
CONDITIONS
Brief 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 a clinical indication for intranasal midazolam by the attending physician
- Patient willing and able to provide written informed consent
- Patient willing and able to complete anxiety assessments
- For nested pharmacokinetic analysis: patients with available venous access and willing to provide blood samples
You will not qualify if you...
- Intranasal midazolam prescribed for seizures
- Midazolam prescribed for continuous sedation
- History of allergy or hypersensitivity to midazolam
- History of benzodiazepine-related paradoxical reaction to midazolam
- Acute narrow-angle glaucoma
- Impaired nasal absorption (e.g., nasal obstruction, polyps)
- Intranasal midazolam use within 24 hours before enrollment
- Less than 24 hours between informed consent and planned midazolam administration
- Use of strong CYP3A4 inducers or inhibitors
- Recently started strong opioid therapy within past 5 days
- Use of other CNS depressants causing significant sedation
- Inability to follow study procedures due to language barriers or dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment at the time of midazolam prescription
Duration - Single day
Participants receive a single dose of intranasal midazolam or placebo as prescribed and randomized.
1 baseline visit including administration and assessment immediately before and 30 minutes after intervention
Duration - Up to 24 hours after intervention
Participants are monitored for up to 24 hours after the intervention to assess additional dose requests, adverse events, and cumulative dose usage.
Assessments starting 30 minutes after intervention and continuing up to 24 hours
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
U
Ursina Wernli, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here