Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946928
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-07-07
Brief Title:
EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING A RETROSPECTIVE COHORT STUDY
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
CLINICAL EVALUATION AND IMPACT ON EMERGENCE AGITATION OF AN ORAL SOLUTION OF MIDAZOLAM CONTAINING g-CICLODEXSTRIN IN PAEDIATRIC MAGNETIC RESONANCE IMAGING A RETROSPECTIVE COHORT STUDY
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
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:
premidazolam
Brief Summary:
The aim of this study was to assess the anxiolytic and sedative effect of OZALIN OZASED ADV6209 025mgKg in children undergoing magnetic resonance imaging MRI under inhalational anesthesia Our hypothesis is that compared to children who do not receive any premedication palatability of OZALIN OZASED by allowing an easier acceptance of the drug improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes including emergence agitation
Detailed Description:
Magnetic resonance imaging is considered the primary investigative tool for evaluating a wide range of paediatric medical conditions Sedatives are often needed in this population to ensure immobilization during the acquisition of the images
Midazolam has always been the most used anxiolytic-sedative drug in the pediatric population Over time the intravenous formulation of midazolam has been used also for oral nasal or rectal administration but those alternative routes of administration represent an off-label use Recently in Europe was licensed ADV6209 a midazolam solution for oral use containing gamma-cyclodextrin OZALIN OZASED
The aim of this study was to assess its anxiolytic and sedative effect at a dosage of 025mgKg in children undergoing magnetic resonance imaging MRI under inhalational anesthesia Our hypothesis is that compared to children who do not receive any premedication palatability of OZALIN OZASED by allowing an easier acceptance of the drug improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes including emergence agitation
Midazolam has always been the most used anxiolytic-sedative drug in the pediatric population Over time the intravenous formulation of midazolam has been used also for oral nasal or rectal administration but those alternative routes of administration represent an off-label use Recently in Europe was licensed ADV6209 a midazolam solution for oral use containing gamma-cyclodextrin OZALIN OZASED
The aim of this study was to assess its anxiolytic and sedative effect at a dosage of 025mgKg in children undergoing magnetic resonance imaging MRI under inhalational anesthesia Our hypothesis is that compared to children who do not receive any premedication palatability of OZALIN OZASED by allowing an easier acceptance of the drug improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes including emergence agitation
Study Oversight
Has Oversight DMC:
None
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?:
None