Clinical trial NCT05946928: EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Premedication
Brain Neoplasms
Brain Pathology
Growth Retardation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the IRCCS Agostino Gemelli Foundation of Catholic University of Rome

Brief 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.

Eligibility criteria: Inclusion Criteria:

- We included in the study 100 children (either gender), aged 1-10 years, American Society of Anaesthesiologists (ASA) physical status 1 and 3 who, between March and December 2022, received inhalation anesthesia for brain and spinal cord MRI for diagnostic investigations or postoperative and oncological follow-up

Exclusion Criteria:

* 1) a history of hypersensitivity to midazolam; 2) chronic therapy with benzodiazepines; 3) acute respiratory tract infections; 4) psychiatric and behavioural disorders; 5) ASA physical status \>3.

Primary outcomes:
measure: evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction.
timeFrame: 30 minutes within premedication administration
Secondary outcomes:
measure: the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia
timeFrame: procedure (at induction of general anesthesia)
measure: time to eye closure at induction of anesthesia;
timeFrame: procedure (at induction of general anesthesia)
measure: patient degree of acceptance of the administered premedication
timeFrame: 30 minutes before induction of general anesthesia
measure: evaluation of OZALIN® / OZASED® anxiolytic efficacy
timeFrame: 30 minutes after premedication administration
measure: child's behavior on separation from the parent
timeFrame: baseline (before induction of general anesthesia)
measure: occurrence of delirium at the emergence from anesthesia
timeFrame: at emergence of anesthesia procedure
measure: evaluation of behavioural changes seven days after the procedure, between the two groups.
timeFrame: 7 days after the magnetic resonance Imaging
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. gemelli IRCCS
name: Rossella Garra
role: PRINCIPAL_INVESTIGATOR
References: