| Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. | |
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MedLine Citation:
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PMID: 20679166 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy. DESIGN: Prospective randomized study. SETTING: Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states. PATIENTS: A total of 358 pediatric patients who visited a pediatric neurology clinic from July 2006 through September 2008 and were prescribed a home rescue medication for their next seizure. INTERVENTION: Caretakers were randomized to use either 0.2 mg/kg of IN-MMAD (maximum, 10 mg) or 0.3 to 0.5 mg/kg of RD (maximum, 20 mg) at home for their child's next seizure if it lasted more than 5 minutes. OUTCOME MEASURES: The primary outcome measure was total seizure time after medication administration. Our secondary outcome measures were total seizure time, time to medication administration, respiratory complications, emergency medical service support, emergency department visits, hospitalizations, and caretakers' ease of administration and satisfaction with the medication. RESULTS: A total of 92 caretakers gave the study medication during a child's seizure (50 IN-MMAD, 42 RD). The median time from medication administration to seizure cessation for IN-MMAD was 1.3 minutes less than for RD (95% confidence interval, 0.0-3.5 minutes; P=.09). The median time to medication administration was 5.0 minutes for each group. No differences in complications were found between treatment groups. Caretakers were more satisfied with IN-MMAD and report that it was easier to give than RD. CONCLUSIONS: There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD. Trial Registration clinicaltrials.gov Identifier: NCT00326612. |
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Authors:
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Maija Holsti; Nanette Dudley; Jeff Schunk; Kathleen Adelgais; Richard Greenberg; Cody Olsen; Aaron Healy; Sean Firth; Francis Filloux |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Archives of pediatrics & adolescent medicine Volume: 164 ISSN: 1538-3628 ISO Abbreviation: Arch Pediatr Adolesc Med Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-08-03 Completed Date: 2010-08-26 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9422751 Medline TA: Arch Pediatr Adolesc Med Country: United States |
Other Details:
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Languages: eng Pagination: 747-53 Citation Subset: AIM; IM |
Affiliation:
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Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, USA. maija.holsti@hsc.utah.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00326612 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Administration, Intranasal Administration, Rectal Anticonvulsants / administration & dosage* Child Child, Preschool Diazepam / administration & dosage* Double-Blind Method Epilepsy / drug therapy* Female Home Care Services Humans Male Midazolam / administration & dosage* Nebulizers and Vaporizers Prospective Studies |
| Chemical | |
Reg. No./Substance:
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0/Anticonvulsants; 439-14-5/Diazepam; 59467-70-8/Midazolam |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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