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Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

This study has been completed.
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
Maija Holsti, University of Utah
ClinicalTrials.gov Identifier:
NCT00326612
First received: May 15, 2006
Last updated: September 19, 2011
Last verified: September 2011
Results First Received: March 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Seizures
Interventions: Drug: Midazolam
Drug: Diazepam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from a pediatric Neurology clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intranasal Midazolam 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
Rectal Diazepam 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes

Participant Flow:   Overall Study
    Intranasal Midazolam     Rectal Diazepam  
STARTED     179     179  
COMPLETED     50     42  
NOT COMPLETED     129     137  
They did not have a seizure requiring tx                 129                 137  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intranasal Midazolam 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
Rectal Diazepam 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
Total Total of all reporting groups

Baseline Measures
    Intranasal Midazolam     Rectal Diazepam     Total  
Number of Participants  
[units: participants]
  50     42     92  
Age  
[units: participants]
     
<=18 years     50     42     92  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  6.8  ± 5.0     7.3  ± 4.5     7.0  ± 4.8  
Gender  
[units: participants]
     
Female     26     20     46  
Male     24     22     46  
Region of Enrollment  
[units: participants]
     
United States     50     42     92  



  Outcome Measures
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1.  Primary:   Length of Seizure After Study Medication Administration   [ Time Frame: 24 hours ]

2.  Secondary:   Respiratory Depression Requiring Intubation   [ Time Frame: 24 hours ]

3.  Secondary:   Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours   [ Time Frame: 24 hours ]

4.  Secondary:   Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.   [ Time Frame: 24 hours ]

5.  Secondary:   Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.   [ Time Frame: 24 hours ]

6.  Secondary:   Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication   [ Time Frame: 12 hours ]

7.  Secondary:   Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maija Holsti, MD, MPH
Organization: DIvision of Pediatric Emergency Medicine
phone: 801-587-7450
e-mail: maija.holsti@hsc.utah.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: Maija Holsti, University of Utah
ClinicalTrials.gov Identifier: NCT00326612     History of Changes
Other Study ID Numbers: 15275
Study First Received: May 15, 2006
Results First Received: March 10, 2011
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration