Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study
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OBJECTIVE: To compare the safety and efficacy of midazolam given intranasally with diazepam given intravenously in the treatment of children with prolonged febrile seizures. DESIGN: Prospective randomised study. SETTING: Paediatric emergency department in a general hospital. SUBJECTS: 47 children aged six months to five years with prolonged febrile seizure (at least 10 minutes) during a 12 month period. INTERVENTIONS: Intranasal midazolam (0.2 mg/kg) and intravenous diazepam (0.3 mg/kg). MAIN OUTCOME MEASURES: Time from arrival at hospital to starting treatment and cessation of seizures. RESULTS: Intranasal midazolam and intravenous diazepam were equally effective. Overall, 23 of 26 seizures were controlled with midazolam and 24 out of 26 with diazepam. The mean time from arrival at hospital to starting treatment was significantly shorter in the midazolam group (3.5 (SD 1.8) minutes, 95% confidence interval 3.3 to 3.7) than the diazepam group (5.5 (2.0), 5.3 to 5.7). The mean time to control of seizures was significantly sooner (6.1 (3.6), 6.3 to 6.7) in the midazolam group than the diazepam group (8.0 (0.5), 7. 9 to 8.3). No significant side effects were observed in either group. CONCLUSION: Seizures were controlled more quickly with intravenous diazepam than with intranasal midazolam, although midazolam was as safe and effective as diazepam. The overall time to cessation of seizures after arrival at hospital was faster with intranasal midazolam than with intravenous diazepam. The intranasal route can possibly be used not only in medical centres but in general practice and, with appropriate instructions, by families of children with recurrent febrile seizures at home.
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For children with acute seizures, intranasal midazolam is both safe and effective.
“studies have suggested that intranasal midazolam is safe and effective for acute seizure management in children (124, 127, 128, 135, 136).”
From Benzodiazepines in epilepsy: Pharmacology and pharmacokinetics (2008) · cites this paper as [124]
Open-label studies suggest that intranasal midazolam is safe and effective for acute seizure management in children.
“Open-label studies have suggested that intranasal midazolam is safe and effective for acute seizure management in children (124, 127, 128, 135, 136).”
From Benzodiazepines in epilepsy: Pharmacology and pharmacokinetics (2008) · cites this paper as [124]
Initial treatment response occurred in 23 of 26 seizures (88%) with intranasal midazolam and 24 of 26 (92%) with intravenous diazepam.
“with 88% of seizures (23 of 26) responding to initial treatment with midazolam and 92% (24 of 26) responding to diazepam (124).”
From Benzodiazepines in epilepsy: Pharmacology and pharmacokinetics (2008) · cites this paper as [124]
In three controlled clinical trials, intranasal midazolam had efficacy similar to or better than intravenous or rectal diazepam.
“In three controlled clinical trials, the efficacy of intranasal midazolam was similar to or better than that of i.v. or rectal diazepam (124, 127, 128).”
From Benzodiazepines in epilepsy: Pharmacology and pharmacokinetics (2008) · cites this paper as [124]
A prospective randomized open-label trial found intranasal midazolam comparable to intravenous diazepam in safety and efficacy for febrile seizure management.
“In a prospective, randomized, open-label study, intranasal midazolam was as safe and effective as i.v.diazepam was for managing febrile seizures”
From Benzodiazepines in epilepsy: Pharmacology and pharmacokinetics (2008) · cites this paper as [124]
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- Authors
- Lahat, E.
- Affiliations
- Assaf Harofeh Medical Center (IL)
- Corresponding author
- Lahat, E.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2000-07-08
- Volume
- 321
- Issue
- 7253
- Pages
- 83-86
- ISSN
- 0959-8138 (ISSN-L)
- PMC
- PMC27427
- OpenAlex
- W2059085344
- Cited by
- 294
- References
- 46
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 6 · 2023: 8 · 2022: 13 · 2021: 11 · 2020: 15 · 2019: 9 · 2018: 8 · 2017: 14 · 2016: 12 · 2015: 25 · 2014: 21 · 2013: 13 · 2012: 11
- FWCI
- 4.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Epilepsy research and treatment
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Anesthesia and Sedative Agents
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- febrile seizures, prolonged febrile seizures, intranasal midazolam, intravenous diazepam, benzodiazepines, seizure control, pediatric emergency care, time to treatment, children
- MeSH terms
- Administration, Intranasal, Anticonvulsants, Child, Child, Preschool, Seizures, Febrile, Diazepam, Female, Humans, Infant, Infusions, Intravenous, Male, Midazolam, Prospective Studies, Treatment Outcome
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