Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 8:53 AM
Study NCT ID:
NCT05894057
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Minitablet) in Clinical Practice
Sponsor:
University Children's Hospital Basel
Organization:
Study Overview
Official Title:
Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study aims to gain knowledge on how the different midazolam formulations (oral syrup, rectal suppository, ODMT) are accepted by 2- to 10-year-old pediatric inpatients and outpatients at the University Children's Hospital Basel (UKBB) in Switzerland. The present study will use non-invasive scoring to assess acceptability of the different midazolam formulations.
Detailed Description:
At the University Children's Hospital Basel (UKBB) in Switzerland, \~ 2500 children are referred to the Pediatric Anesthesiology Unit per year receiving midazolam sedation before surgery. Further, \~2000 children are admitted to the Pediatric Emergency Unit for procedures requiring midazolam sedation per year. Medication palatability is a key element of treatment adherence and successful therapy outcome. In a previous cross-sectional acceptability study in 2- to 10-year-old pediatric patients at UKBB, it was demonstrated that an inorganic calcium carbonate/calcium phosphate carrier material as the main excipient in an oro- dispersible mini-tablet (ODMT) formulation is safe, palatable, and highly acceptable in children. To date, no data for acceptability in terms of palatability and anxiolysis in daily preoperative practice for midazolam oral syrup, rectal suppository or ODMT formulation is available. As such the goal of this observational study is to better understand acceptability of various midazolam formulations (oral syrup, rectal suppository, ODMT) in clinical practice in 2- to 10-year-old pediatric patients at UKBB. .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: