PILOT STUDY COMPARING INTRANASALLY ADMINISTERED DIAZEPAM AND MIDAZOLAM
Abstract number :
3.105
Submission category :
Year :
2002
Submission ID :
3426
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Jennifer R. Riss, Robert L. Kriel, James C. Cloyd. Experimental & Clinical Pharmacology, University of Minnesota, Minneapolis, MN; Pediatric Neurology, Hennepin County Medical Center, Minneapolis, MN
RATIONALE: Intranasal administration offers a potentially valuable means of treating seizure emergencies outside of the hospital. The ideal drug for this indication would be highly concentrated, rapidly and consistently absorbed with an extended duration of effect. The purpose of this study was to compare the pharmacokinetics and tolerability of intranasal diazepam (DZP) and midazolam (MDZ).
METHODS: Two healthy volunteers completed a single-blind, four way cross over study involving intravenous (IV) and intranasal (IN) administration of 5 mg of DZP and MDZ. Serial blood samples were collected over 48 hours and a questionnaire about nasal discomfort and level of alertness (sedation) was completed by the subjects.
RESULTS: The duration of nasal discomfort was brief with subjects returning to baseline in 60 minutes. Sedation was more prolonged, paralleling the time course of plasma concentrations, and was greater following midazolam administration. Please refer to the table for results.
CONCLUSIONS: Based on these preliminary results, DZP appears to have high bioavailability and an extended elimination half life with a T[sub]max[/sub] comparable to MDZ. These properties indicate that IN DZP may be preferable to IN MDZ in treating seizure emergencies.[table1]
[Supported by: University of Minnesota Seed Grant]