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 ]

efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo inhalation


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