Palliative medicine · 2026
A randomized controlled clinical trial of intranasal versus subcutaneous midazolam for agitation in terminal illness (MinTU study).
СтатьяРандомизированное исследованиеКлиническое исследование II фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Hirschinger Hanna, Rémi Constanze, Jäger Evelyn, Nittka Stefanie, Hetjens Svetlana, Saussele Susanne, Merx Kirsten, Koch Jan, Abba Mohammed, Ghazal Mahmoud, Hofheinz Ralf-D, Michaeli Thomas, Sperk Elena, Kohlbrenner Katharina, Hofmann Wolf-K, Gencer Deniz, Boch Tobias
Аннотация
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 No patients withdrawn due to adverse effects.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).
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).