Intranasal Midazolam to Treat Acute Anxiety in Hospitalized Adult Palliative Care Patients A Double-Blind, Randomized, Placebo-Controlled Pilot Study with Pharmacokinetic Analysis

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.

Administration of Intranasal Midazolam for Anxiety in Palliative Care