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Treatment of agitation in terminally ill patients with intranasal midazolam versus subcutaneous midazolam: study protocol for a randomised controlled open-label monocentric trial (MinTU Study)

Authors :
Hanna Hirschinger
Evelyn Jaeger
Stefanie Nittka
Svetlana Hetjens
Christine Lorenz
Constanze Remi
Susanne Saussele
Wolf-K. Hofmann
Deniz Gencer
Tobias Boch
Source :
BMC Palliative Care, Vol 23, Iss 1, Pp 1-7 (2024)
Publication Year :
2024
Publisher :
BMC, 2024.

Abstract

Abstract Background Intranasal (i.n.) drug application is a widely known and low-invasive route of administration that may be able to achieve rapid symptom control in terminally ill patients. According to the German S3 guideline “Palliative care for patients with incurable cancer”, benzodiazepines, such as midazolam, are recommended for the treatment of terminal agitation. To the best of our knowledge there is no evidence for i.n. midazolam in terminally ill patients. We aim to assess the use of i.n. midazolam as an alternative to subcutaneous administration of the drug. Methods In this monocentric, randomised, controlled, open-label investigator initiated trial, n = 60 patients treated at the palliative care unit of a University Hospital will be treated with 5 mg midazolam i.n. versus 5 mg subcutaneous (s.c.) midazolam in the control arm when terminal agitation occurs (randomly assigned 1:1). The estimated recruitment period is 18 months. Treatment efficacy is defined as an improvement on the Richmond Agitation Sedation Scale (Palliative Version) (RASS-PAL) and a study specific numeric rating scale (NRS) before and after drug administration. Furthermore, plasma concentration determinations of midazolam will be conducted at t1 = 0 min, t2 = 5 min, and t3 = 20 min using liquid chromatography/mass spectrometry (LC-MS). The primary objective is to demonstrate non-inferiority of midazolam i.n. in comparison to midazolam s.c. for the treatment of agitation in terminally ill patients. Discussion Midazolam i.n. is expected to achieve at least equivalent reduction of terminal agitation compared to s.c. administration. In addition, plasma concentrations of midazolam i.n. are not expected to be lower than those of midazolam s.c. and the dynamics of the plasma concentration with an earlier increase could be beneficial. Trial registration German Clinical Trials Registry DRKS00026775, registered 07.07.2022, Eudra CT No.: 2021-004789-36.

Details

Language :
English
ISSN :
1472684X
Volume :
23
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMC Palliative Care
Publication Type :
Academic Journal
Accession number :
edsdoj.3ac82afd2aeb4788b503d915f9d4402b
Document Type :
article
Full Text :
https://doi.org/10.1186/s12904-023-01330-1