Clinical Trial: Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures
Brief Summary:
The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo-inhalation.
Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility), the quality of life of the parents and children using the low pressure can with a breathing mask in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.
Detailed Summary:
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: number of patients which need Diazepam [ Time Frame: 3 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- number of severe adverse events [ Time Frame: 3 minutes ]safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting
- manageability of the application assessed by the parents [ Time Frame: 3 minutes ]manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility)
- changes in quality of life of the parents and children after use of study medication [ Time Frame: 3 minutes ]quality of life of the parents and children using the low pressure can with a breathing mask in a home-setting or on the way (mobility)
- contentment and anxiety of the parents [ Time Frame: 3 minutes ]
Original Secondary Outcome:
- number of severe adverse events [ Time Frame: 3 minutes ]safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting
- manageability of the application assessed by the parents [ Time Frame: 3 minutes ]manageability of the Carbogen inhalation via a lowpressure can with a breathing mask in a home-setting or on the way (mobility)
- changes in quality of life of the parents and children after use of studymedication [ Time Frame: 3 minutes ]quality of life of the parents and children using the lowpressure can with a breathing mask in a home-setting or on the way (mobility)
- contentment and anxiety of the parents [ Time Frame: 3 minutes ]
Information By: Charite University, Berlin, Germany
Dates:
Date Received: May 20, 2011
Date Started: August 2012
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015