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Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
This study has been completed.
Study NCT00326612   Information provided by University of Utah

First Received on May 15, 2006.   Last Updated on September 19, 2011   History of Changes
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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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

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


Limitations and Caveats
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.  


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:
Harbord MG, Kyrkou NE, Kyrkou MR, Kay D, Coulthard KP. Use of intranasal midazolam to treat acute seizures in paediatric community settings. J Paediatr Child Health. 2004 Sep-Oct;40(9-10):556-8.
Starreveld E, Starreveld AA. Status epilepticus. Current concepts and management. Can Fam Physician. 2000 Sep;46:1817-23. Review.
Scheepers M, Scheepers B, Clarke M, Comish S, Ibitoye M. Is intranasal midazolam an effective rescue medication in adolescents and adults with severe epilepsy? Seizure. 2000 Sep;9(6):417-22.
Jeannet PY, Roulet E, Maeder-Ingvar M, Gehri M, Jutzi A, Deonna T. Home and hospital treatment of acute seizures in children with nasal midazolam. Eur J Paediatr Neurol. 1999;3(2):73-7.
[No authors listed] Treatment of convulsive status epilepticus. Recommendations of the Epilepsy Foundation of America's Working Group on Status Epilepticus. JAMA. 1993 Aug 18;270(7):854-9. Review.
Chamberlain JM, Altieri MA, Futterman C, Young GM, Ochsenschlager DW, Waisman Y. A prospective, randomized study comparing intramuscular midazolam with intravenous diazepam for the treatment of seizures in children. Pediatr Emerg Care. 1997 Apr;13(2):92-4.
Fisgin T, Gurer Y, Senbil N, Tezic T, Zorlu P, Okuyaz C, Akgun D. Nasal midazolam effects on childhood acute seizures. J Child Neurol. 2000 Dec;15(12):833-5.
Fisgin T, Gurer Y, Tezic T, Senbil N, Zorlu P, Okuyaz C, Akgun D. Effects of intranasal midazolam and rectal diazepam on acute convulsions in children: prospective randomized study. J Child Neurol. 2002 Feb;17(2):123-6.
Kutlu NO, Yakinci C, Dogrul M, Durmaz Y. Intranasal midazolam for prolonged convulsive seizures. Brain Dev. 2000 Sep;22(6):359-61.
Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6.
Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Intranasal midazolam as a treatment of autonomic crisis in patients with familial dysautonomia. Pediatr Neurol. 2000 Jan;22(1):19-22.
Lahat E, Goldman M, Barr J, Eshel G, Berkovitch M. Intranasal midazolam for childhood seizures. Lancet. 1998 Aug 22;352(9128):620. No abstract available.
Lahat E. A prospective, randomized study comparing intramuscular midazolam with intravenous diazepam for the treatment of seizures in children. Pediatr Emerg Care. 1997 Dec;13(6):449. No abstract available.
McGlone R, Smith M. Intranasal midazolam. An alternative in childhood seizures. Emerg Med J. 2001 May;18(3):234. No abstract available.
Rainbow J, Browne GJ, Lam LT. Controlling seizures in the prehospital setting: diazepam or midazolam? J Paediatr Child Health. 2002 Dec;38(6):582-6.
Scott RC, Besag FM, Neville BG. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomised trial. Lancet. 1999 Feb 20;353(9153):623-6.
Wallace SJ. Nasal benzodiazepines for management of acute childhood seizures? Lancet. 1997 Jan 25;349(9047):222. No abstract available.
Wroblewski BA, Joseph AB. The use of intramuscular midazolam for acute seizure cessation or behavioral emergencies in patients with traumatic brain injury. Clin Neuropharmacol. 1992 Feb;15(1):44-9.
Pellock JM. Status epilepticus in children: update and review. J Child Neurol. 1994 Oct;9 Suppl 2:27-35. Review.
Verity CM. Do seizures damage the brain? The epidemiological evidence. Arch Dis Child. 1998 Jan;78(1):78-84. Review. No abstract available.
Alldredge BK, Wall DB, Ferriero DM. Effect of prehospital treatment on the outcome of status epilepticus in children. Pediatr Neurol. 1995 Apr;12(3):213-6.
Knoester PD, Jonker DM, Van Der Hoeven RT, Vermeij TA, Edelbroek PM, Brekelmans GJ, de Haan GJ. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol. 2002 May;53(5):501-7.
Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5.
Vilke GM, Sharieff GQ, Marino A, Gerhart AE, Chan TC. Midazolam for the treatment of out-of-hospital pediatric seizures. Prehosp Emerg Care. 2002 Apr-Jun;6(2):215-7.

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