Evidence map›Paper›PMID 41866851›Full record

Trial reportPalliative medicine2026

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

Hanna Hirschinger, Constanze Rémi, Evelyn Jäger, Stefanie Nittka, Svetlana Hetjens, Susanne Saussele, Kirsten Merx, Jan Koch, Mohammed Abba, Mahmoud Ghazal and 7 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Palliative medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Hanna Hirschinger3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.ORCID 0009-0007-6384-9801
Constanze RémiHospital Pharmacy and Department of Palliative Medicine, LMU University Hospital, LMU Munich, Munich, Germany.ORCID 0000-0001-7655-0306
Evelyn JägerInstitute for Clinical Chemistry, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Stefanie NittkaInstitute for Clinical Chemistry, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Svetlana HetjensDepartment of Medical Statistics, Biomathematics and Information Processing, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Susanne Saussele3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Kirsten Merx3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Jan Koch3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Mohammed Abba3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Mahmoud Ghazal3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Ralf-D Hofheinz3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Thomas Michaeli3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Elena Sperk3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Katharina Kohlbrenner3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Wolf-K Hofmann3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.
Deniz GencerOeschelbronn Clinic, Centre for Integrative Oncology, Pain and Palliative Medicine, Oeschelbronn, Germany.
Tobias Boch3rd Department of Medicine, Medical Faculty Mannheim, University of Heidelberg, University Medical Center Mannheim, Mannheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTerminally 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.

aimTo evaluate the effectiveness of intranasal compared with subcutaneous midazolam for the initial management of terminal agitation in palliative care patients.

designRandomized, investigator-initiated open-label phase-II trial, August 2022-July 2024. SETTING/

participantsMonocentric 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 ( PRIMARY OUTCOME: Improvement of terminal agitation by midazolam administration assessed by RASS-PAL-score. SECONDARY OUTCOME: Midazolam plasma concentrations after administration.

resultsMedian 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

conclusionMidazolam 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 registrationMinTU Study 173-01, Eudra CT No.: 2021-004789-36, DRKS ID: 00026775 (07.07.2022, https://drks.de/search/de/trial/DRKS00026775).

Indexed as

Hypnotics and SedativesMidazolamPalliative CarePsychomotor AgitationTerminal CareTerminally IllAdministration, IntranasalAgedAged, 80 and overFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeHypnotics and SedativesMidazolamagitationend-of-lifeintranasalmidazolampalliative care

Identifiers

PMID41866851
PMCPMC13221569

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.