Emergency Medical Services and Epilepsy in Switzerland

Treatment of Epilepsy in Children and Adults in the Emergency Medical Services of the City of Zurich, Switzerland - Midazolam Versus Diazepam - A Retrospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy

• Study Type: Observational
• Enrollment (Actual): 584

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Theusinger Oliver M.
• Investigators: Study Chair: Oliver M Theusinger, MD, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; Emergency medical services
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Epilepsy; Emergencies
• Other Study ID Numbers: OMT 01012015 SRZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No