Administration of Intranasal Midazolam for Anxiety in Palliative Care

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a medication called midazolam, given through the nose, to help relieve acute anxiety in patients receiving palliative care. Palliative care is specialized medical care for people with serious illnesses, focusing on providing relief from symptoms and improving quality of life. The study will look at how well different doses of midazolam work to reduce anxiety and whether it is safe for patients. It is a double-blind study, meaning that neither the patients nor the doctors know who is receiving the actual medication or a placebo (a treatment that has no active ingredients).

To participate in the trial, patients must be adults aged 18 or older, currently in palliative care, and experiencing acute anxiety that their doctor believes could be treated with midazolam. They also need to be able to give consent to participate and complete anxiety assessments. However, some patients may not qualify, such as those who have specific allergies, certain eye conditions, or those currently taking other medications that could interfere with the study. Participants can expect to receive either midazolam or a placebo during the trial, and their progress will be closely monitored to assess the effects of the treatment. This trial aims to gather important information that could help improve anxiety management for patients in palliative care.

Gender

ALL

Eligibility criteria

• 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)