Intranasal Midazolam Compared with Intravenous Diazepam in Patients Suffering from Acute Seizure: A Randomized Clinical Trial

Hedyeh Saneifard; Mozhgan Hashemieh; Mohsen Javadzadeh; Koroush Sheibani

IJ Pediatrics

The Scientific Journal of Growth & Development Research Center

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Intranasal Midazolam Compared with Intravenous Diazepam in Patients Suffering from Acute Seizure: A Randomized Clinical Trial

Author(s):

Hedyeh Saneifard¹,

Mozhgan Hashemieh¹,

Mohsen Javadzadeh¹,

Koroush Sheibani^2,*

1Department of Pediatrics, Shahid Beheshti University of Medical Sciences, Tehran, Iran

2Clinical Research and Development Center, Imam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

IJ Pediatrics:Vol. 22, issue 1; 1-8

Published online:Mar 31, 2012

Article type:Research Article

Received:Jan 17, 2011

Accepted:Oct 02, 2011

How to Cite:Hedyeh SaneifardMozhgan HashemiehMohsen JavadzadehKoroush SheibaniIntranasal Midazolam Compared with Intravenous Diazepam in Patients Suffering from Acute Seizure: A Randomized Clinical Trial.Iran J Pediatr.22(1):1-8.

Abstract

Objective: Acute seizure attack is a stressful experience both for health care personnel and parents. These attacks might cause morbidity and mortality among patients, so reliable methods to control the seizure preferably at home should be developed. This study was performed to measure the time needed to control seizure attacks using intranasal midazolam compared to the common treatment (intravenous diazepam) and to evaluate its probable side effects.
Methods: This study was conducted as a not blind randomized clinical trial among 60 patients coming to Imam Ali Hospital, Zahedan, Iran. The patients were 2 months to 15 years old children coming to our emergency department suffering from an acute seizure episode. Intranasal midazolam was administered 0.2 mg/kg equally dropped in both nostrils for case group and intravenous diazepam was administered 0.3mg/kg via IV line for control group. After both treatments the time needed to control the seizure was registered by the practitioner. Pulse rate and O2 saturation were recorded at patients’ entrance and in minutes 5 and 10 after drug administration.
Findings: The time needed to control seizure using intranasal midazolam (3.16±1.24) was statistically shorter than intravenous diazepam (6.42±2.59) if the time needed to establish IV line in patients treated by intravenous diazepam is taken into account (P<0.001). The readings for O2 saturation or heart rate did not indicate a statistically significant difference between two groups of patients either at entrance or 5 and 10 minutes after drug administration.
Conclusion: Considering the shorter time needed to control acute seizure episodes compared to intravenous diazepam and its safety record, intranasal midazolam seems to be a good candidate to replace diazepam, as the drug of choice, in controlling this condition.

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