Clinical Research Directory

Inclusion Criteria: * Adult palliative care patients (≥ 18 years) hospitalized at one of the study sites * Self-reported acute anxiety with clinical indication for intranasal midazolam administration according to attending physician * Patient willing and able to provide written informed consent * Informed consent as documented by signature * Patient willing and able to complete anxiety assessment * Additionally for nested pharmacokinetic analysis: Patients with available central or peripheral venous access, i.e., peripheral venous catheter (PVC), central venous catheter (CVC), peripherally inserted central venous catheter (PICC) line, midline catheter, or PORT-A-CATH® (PAC), and patient willing and able to provide blood samples Exclusion Criteria: * Intranasal midazolam prescribed for seizures * Midazolam (any route of administration) prescribed and administered 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., nasogastric tube, nasal obstruction, nasal polyps, etc.) * Intranasal midazolam within 24 h before study enrollment * Time between informed general consent for study participation through investigators and planned midazolam administration \< 24 h * Co-medication with strong CYP3A4 inducers or inhibitors according to pre-defined list (FDA) * Recently initiated therapy with strong opioids (i.e., within past 5 days) * Co-medication with other CNS depressants causing clinically relevant degree of sedation * Inability to follow the procedures of the study (i.e., provision of Informed Consent, completion of assessment tool, e.g., due to language problems or dementia)