Pilot study to investigate the pharmacokinetics and tolerability of midazolam nose spray
Not Applicable
Completed
- Conditions
- Epileptic seizuresNervous System Diseases
- Registration Number
- ISRCTN79059168
- Lead Sponsor
- Maastricht University Medical Centre (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
1. Age more than or equal to 18 years, either sex
2. American Society of Anesthesiology patient classification status (ASA) I and II
Exclusion Criteria
1. Allergy to benzodiazepines
2. Acute or chronic nasal problems like rhinitis or sinusits
3. Use of benzodiazepines or grapefruit was prohibitied for a week prior to the research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of midazolam nose spray (5 mg, 50 mg/mL formulation) compared with intravenous administration (2.5 mg) - Blood samples for pharmacokinetic analysis were collected from an intravenous (IV) cannula at baseline and at 3.5,15, 20, 30, 40, 60, 90,120,180 and 240 minutes post-dose. Pharmacokinetic data [maximum concentration (Cmax), time to maximum plasma concentration (Tmax), biological half life (t1/2), area under the Curve (AUC)] are analysed using two-compartment analysis.
- Secondary Outcome Measures
Name Time Method Tolerability of midazolam nose spray (50 mg/mL formulation) - Subjects are instructed to inform the investigator of any untoward effects occuring during the study, including both local adverse events and systemic adverse events. Major expected side effects, like drowsiness and local burning feeling, were registered by a Visual Analogue Scale (VAS) form 0 = no complaint at all to 100 = worst complaint possible, others were described.