Cover Image

A randomized controlled clinical trial of intranasal versus subcutaneous midazolam for agitation in terminal illness (MinTU study)

Background: Terminally ill patients often have difficulty taking medications. Suitable, minimally invasive, fast-acting administration routes are particularly important. Trials on alternative drug administration routes in palliative care are essential to base therapy decisions on evidence rather tha...

Full description

Saved in:
Bibliographic Details
Main Authors: Hirschinger, Hanna (Author) , Rémi, Constanze (Author) , Jäger, Evelyn (Author) , Nittka, Stefanie (Author) , Hetjens, Svetlana (Author) , Saußele, Susanne (Author) , Merx, Kirsten (Author) , Koch, Jan (Author) , Abba, Mohammed L. (Author) , Ghazal, Mahmoud (Author) , Hofheinz, Ralf-Dieter (Author) , Michaeli, Christoph T. (Author) , Sperk, Elena (Author) , Kohlbrenner, Katharina (Author) , Hofmann, Wolf-Karsten (Author) , Gencer, Deniz (Author) , Boch, Tobias (Author)
Format: Article (Journal)
Language:English
Published: March 22, 2026
In: Palliative medicine
Year: 2026, Pages: 1-12
ISSN:1477-030X
DOI:10.1177/02692163261428947
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1177/02692163261428947
Get full text
Author Notes:Hanna Hirschinger, Constanze Rémi, Evelyn Jäger, Stefanie Nittka, Svetlana Hetjens, Susanne Saussele, Kirsten Merx, Jan Koch, Mohammed Abba, Mahmoud Ghazal, Ralf-D Hofheinz, Thomas Michaeli, Elena Sperk, Katharina Kohlbrenner, Wolf-K Hofmann, Deniz Gencer and Tobias Boch
Description
Summary:Background: Terminally ill patients often have difficulty taking medications. Suitable, minimally invasive, fast-acting administration routes are particularly important. Trials on alternative drug administration routes in palliative care are essential to base therapy decisions on evidence rather than experience. - Aim: To evaluate the effectiveness of intranasal compared with subcutaneous midazolam for the initial management of terminal agitation in palliative care patients. - Design: Randomized, investigator-initiated open-label phase-II trial, August 2022-July 2024. - Setting/Participants: Monocentric trial at the palliative care ward of a German University Hospital. 180 patients were assessed for suitability, 60 patients (median age, 68 years (SD 12.3), 26 female) were randomized 1:1 and analyzed. Patients with terminal agitation fulfilling all eligibility criteria were randomized to midazolam 5 mg administered either intranasal (n = 30) or subcutaneous (n = 30). Primary outcome: Improvement of terminal agitation by midazolam administration assessed by RASS-PAL-score. Secondary outcome: Midazolam plasma concentrations after administration. - Results: Median RASS-PAL-scores decreased significantly in both groups. Intranasal group: 2 at baseline, to -1 at 5 min and -2 at 20 min. Subcutaneous group: 1,-0 and -1. Within-group reductions exceeded the clinically relevant threshold of ⩾ 1 point at 5 and 20 min (all p < 0.0001). Median midazolam plasma concentrations were significantly higher intranasal (5 min: 90 ng/ml, 20 min: 83 ng/ml) than subcutaneous (5 min: 15 ng/ml, 20 min: 24 ng/ml). No patients withdrawn due to adverse effects. - Conclusion: Midazolam intranasal administration was effective in reducing terminal agitation and achieves higher plasma concentrations compared to subcutaneous administration. It is an alternative route of application to improve end-of-life care for terminally ill patients. - Trial Registration: MinTU Study 173-01, Eudra CT No.: 2021-004789-36, DRKS ID: 00026775 (07.07.2022, https://drks.de/search/de/trial/DRKS00026775).
Item Description:Gesehen am 14.04.2026
Physical Description:Online Resource
ISSN:1477-030X
DOI:10.1177/02692163261428947

Similar Items