NCT05946928

EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to assess the anxiolytic and sedative effect of OZALIN® / OZASED® (ADV6209) 0,25mg/Kg 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 0,25mg/Kg 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.

Conditions

• Autism Spectrum Disorder
• Premedication
• Brain Neoplasms
• Brain Pathology
• Growth Retardation

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2023-07-14
• Last updated: 2023-07-17

Locations

1 site across 1 country: Italy