Randomized controlled trial of the use of intranasal midazolam for the treatment of terminal agitation in palliative care patients

Phase 2

Recruiting

Conditions: according to ICD 10: Z51.5PALLIATIVE TREATMENTTreatment of terminal agitation in the final phase
Z51
Other medical care

Registration Number: DRKS00026775

Lead Sponsor: niversität Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient in a palliative stage of disease.
-Age = 18 years
-Personal information of the patient by one of the investigators.
-Ability of the participant to understand the nature and scope of the clinical trial
-Written informed consent of the patient
-Diagnosis final phase
-Diagnosis of terminal agitation
-RASS-PAL Score > 0

Exclusion Criteria

-Diseases affecting nasal absorption.
-Hypersensitivity to midazolam or to any other component/excipient of the study medication
-Parallel use of strong CYP 3A4 inducers or CYP 3A4 inhibitors
-Other causes are responsible for the observed agitation symptomatology and can be treated causally
-A non-drug therapy is effective and leads to improvement of the restlessness symptoms
-Pregnant and breastfeeding women

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
By improving the RASS-PAL score by at least one point between two observation times after i. n. application, we will determine whether intranasal application of midazolam reduces the symptomatology of terminal agitation.<br>To compare the severity of agitation symptomatology before and after drug application (5 and 20 minutes) using RASS-PAL score.

Secondary Outcome Measures

Name	Time	Method
By improvement in the RASS-PAL score by at least one point between two observation time points after s. c. application, it will be determined whether the standard therapy according to the recommendation of the S3 guideline palliative care for patients with a non-curable cancer, by subcutaneous application of midazolam, reduces the symptomatology of terminal agitation.<br>-<br>By demonstrating a midazolam drug concentration in the blood of c = 30 ng/ml after t3=20 min, it should be established that twenty minutes after the first midazolam application, regardless of the mode of application (i. n. or s. c.), therapeutic drug levels in a concentration range c = 30 ng/ml are achieved.<br>-<br>Quantitative analysis of blood samples at t2=5 min after drug application will be used to determine whether midazolam flushes faster or at least as fast after intranasal application as after subcutaneous injection.