Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

NCT00326612 | Completed Phase 2 Results

• 1 other identifier: 15275
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis is that nasal midazolam will be more effective and have shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses are that patients treated with nasal midazolam will have fewer respiratory complications, emergency department visits, and admissions.

Conditions

Seizures

Keywords

Seizures

Outcome Measures

Primary Outcomes (1)

• Length of Seizure After Study Medication Administration

  Length of seizure.

  24 hours

Secondary Outcomes (6)

• Respiratory Depression Requiring Intubation

  24 hours

• Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours

  24 hours

• Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.

  24 hours

• Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.

  24 hours

• Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication

  12 hours

Study Arms (2)

Intranasal Midazolam 0.2mg/kg

ACTIVE COMPARATOR

GIve once for seizure longer than 5 minutes

Drug: Midazolam

Rectal Diazepam 0.3-0.5 mg/kg

ACTIVE COMPARATOR

Given once for seizure longer than 5 minutes

Drug: Diazepam

Interventions

Midazolam DRUG

Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.

Also known as: Diastat

Intranasal Midazolam 0.2mg/kg

Diazepam DRUG

Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.

Also known as: Versed

Rectal Diazepam 0.3-0.5 mg/kg

Eligibility Criteria

• Age: 1 Week - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children seventeen years and under will be identified through a Pediatric Neurology clinic at Primary Children's Medical Center,
• Known seizure disorder, AND
• Either have or will be prescribed a rescue anti-epileptic (rectal diazepam, or Diastat) for home use by their neurologist.

You may not qualify if:

• The neurologist does not prescribe a rescue medication for home use,
• years of age or older,
• They have absence seizures, OR
• They have been prescribed lorazepam for home use for seizure activity.

Sponsors & Collaborators

• University of Utah: lead
• Primary Children's Hospital: collaborator

Study Sites (1)

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Related Publications (25)

• 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. doi: 10.1111/j.1440-1754.2004.00463.x.

  PMID: 15367152 BACKGROUND

• Starreveld E, Starreveld AA. Status epilepticus. Current concepts and management. Can Fam Physician. 2000 Sep;46:1817-23.

  PMID: 11013800 BACKGROUND

• 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. doi: 10.1053/seiz.2000.0425.

  PMID: 10985999 BACKGROUND

• 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. doi: 10.1053/ejpn.1999.0185.

  PMID: 10700542 BACKGROUND

• 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.

  PMID: 8340986 BACKGROUND

• 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. doi: 10.1097/00006565-199704000-00002.

  PMID: 9127414 BACKGROUND

• 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. doi: 10.1177/088307380001501219.

  PMID: 11198507 BACKGROUND

• 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. doi: 10.1177/088307380201700206.

  PMID: 11952072 BACKGROUND

• Kutlu NO, Yakinci C, Dogrul M, Durmaz Y. Intranasal midazolam for prolonged convulsive seizures. Brain Dev. 2000 Sep;22(6):359-61. doi: 10.1016/s0387-7604(00)00155-8.

  PMID: 11042416 BACKGROUND

• 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. doi: 10.1136/bmj.321.7253.83.

  PMID: 10884257 BACKGROUND

• 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. doi: 10.1016/s0887-8994(99)00109-5.

  PMID: 10669200 BACKGROUND

• Lahat E, Goldman M, Barr J, Eshel G, Berkovitch M. Intranasal midazolam for childhood seizures. Lancet. 1998 Aug 22;352(9128):620. doi: 10.1016/S0140-6736(05)79574-X. No abstract available.

  PMID: 9746026 BACKGROUND

• 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.

  PMID: 9435015 BACKGROUND

• McGlone R, Smith M. Intranasal midazolam. An alternative in childhood seizures. Emerg Med J. 2001 May;18(3):234. doi: 10.1136/emj.18.3.234. No abstract available.

  PMID: 11354231 BACKGROUND

• 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. doi: 10.1046/j.1440-1754.2002.00046.x.

  PMID: 12410871 BACKGROUND

• 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. doi: 10.1016/S0140-6736(98)06425-3.

  PMID: 10030327 BACKGROUND

• Wallace SJ. Nasal benzodiazepines for management of acute childhood seizures? Lancet. 1997 Jan 25;349(9047):222. doi: 10.1016/S0140-6736(05)64856-8. No abstract available.

  PMID: 9014904 BACKGROUND

• 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. doi: 10.1097/00002826-199202000-00006.

  PMID: 1576597 BACKGROUND

• Pellock JM. Status epilepticus in children: update and review. J Child Neurol. 1994 Oct;9 Suppl 2:27-35.

  PMID: 7806783 BACKGROUND

• Verity CM. Do seizures damage the brain? The epidemiological evidence. Arch Dis Child. 1998 Jan;78(1):78-84. doi: 10.1136/adc.78.1.78. No abstract available.

  PMID: 9534684 BACKGROUND

• 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. doi: 10.1016/0887-8994(95)00044-g.

  PMID: 7619187 BACKGROUND

• 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. doi: 10.1046/j.1365-2125.2002.01588.x.

  PMID: 11994056 BACKGROUND

• 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. doi: 10.1016/j.yebeh.2004.01.003.

  PMID: 15123028 BACKGROUND

• 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. doi: 10.1080/10903120290938571.

  PMID: 11962570 BACKGROUND

• Holsti M, Dudley N, Schunk J, Adelgais K, Greenberg R, Olsen C, Healy A, Firth S, Filloux F. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010 Aug;164(8):747-53. doi: 10.1001/archpediatrics.2010.130.

  PMID: 20679166 DERIVED

MeSH Terms

Conditions

Seizures

Interventions

Midazolam; Diazepam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepinones

Results Point of Contact

• Title: Maija Holsti, MD, MPH
• Organization: DIvision of Pediatric Emergency Medicine

maija.holsti@hsc.utah.edu

801-587-7450

Study Officials

• Maija Holsti, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

• Francis Filloux, MD

  University of Utah

  STUDY CHAIR

• Jeff Schunk, MD

  University of Utah

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Division of Pediatric Emergency Medicine

Study Record Dates

• First Submitted: May 15, 2006
• First Posted: May 17, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 26, 2011
• Results First Posted: October 26, 2011

Record last verified: 2011-09

Locations

US (1)