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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03346382
Other study ID # OMT 01012015 SRZ
Secondary ID
Status Completed
Phase N/A
First received November 2, 2017
Last updated November 14, 2017
Start date March 1, 2015
Est. completion date June 30, 2016

Study information

Verified date November 2017
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Furthermore, children versus adults were compared. Continuous variables were summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups were compared using the independent samples t-test. P-values < 0.05 are considered significant.


Recruitment information / eligibility

Status Completed
Enrollment 584
Est. completion date June 30, 2016
Est. primary completion date December 31, 2015
Accepts healthy volunteers
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria:

- emergency calls for epileptic seizures received by the emergency medical system of Zurich,Switzerland,

- the use of midazolam or diazepam or no drug used.

Exclusion Criteria:

- the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Theusinger Oliver M.

Outcome

Type Measure Description Time frame Safety issue
Primary Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient.
Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups are compared using the independent samples t-test. P-values < 0.05 are considered significant.
follow up up to 1 year
Secondary Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient.
Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups are compared using the independent samples t-test. P-values < 0.05 are considered significant.
follow up up to 1 year
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