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Emergency Medical Services and Epilepsy in Switzerland

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ClinicalTrials.gov Identifier: NCT03346382
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Epilepsy

Study Design

Study Type : Observational
Actual Enrollment : 584 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment of Epilepsy in Children and Adults in the Emergency Medical Services of the City of Zurich, Switzerland - Midazolam Versus Diazepam - A Retrospective Analysis
Actual Study Start Date : March 1, 2015
Primary Completion Date : December 31, 2015
Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting [ Time Frame: follow up up to 1 year ]

    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.



Secondary Outcome Measures :
  1. Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome [ Time Frame: follow up up to 1 year ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
retrospective collected data from the emergency medical system "Schutz & Rettung Zürich", Zurich, Switzerland, over an 18 months period from 01. June 2013 till 31. December 2014 - all calls for epileptic seizures
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346382


Sponsors and Collaborators
Theusinger Oliver M.
Investigators
Study Chair: Oliver M Theusinger, MD University Hospital Balgrist
More Information

Responsible Party: Theusinger Oliver M., Principal Investigator, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03346382     History of Changes
Other Study ID Numbers: OMT 01012015 SRZ
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theusinger Oliver M., Balgrist University Hospital:
Epilepsy
Emergency medical services

Additional relevant MeSH terms:
Emergencies
Epilepsy
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases