Fondazione Policlinico Agostino Gemelli IRCCS
Rome, 00135, Italy
NCT Number: NCT05946928
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.
Looking for future studies?
Notify Me1 year–10 year
All sexes
Observational
Rome, 00135, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 minutes within premedication administration
evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction evaluated on a four-point scale (Mask Acceptance Scale, MAS) indicating that child is cooperative and accept the mask readily (MAS=1), he is slight fearful and accepts the mask with mild resistance (MAS=2), with moderate struggle (MAS=3) or he resists strongly and must be restrained (MAS=4)
Time frame: procedure (at induction of general anesthesia)
the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia;
Time frame: procedure (at induction of general anesthesia)
time to eye closure at induction of anesthesia
Time frame: 30 minutes before induction of general anesthesia
degree of acceptance of the administered premedication
Time frame: 30 minutes after premedication administration
OZALIN® / OZASED® anxiolytic efficacy was evaluated 30 minutes after premedication administration with the Ramsay sedation scale
Time frame: baseline (before induction of general anesthesia)
Child's behavior at the moment of separation from the parent just before induction of anesthesia was evaluated with a four-point Parental Separation Anxiety scale (PSAS)
Time frame: at emergence of anesthesia procedure
The occurrence of emergence delirium at the end of the procedure was measured using the five items of the Pediatric Anesthesia Emergence Delirium scale (PAED)
Time frame: 7 days after the magnetic resonance Imaging
Maladaptive behavioural responses and developmental regression seven days after the procedure were evaluated by parents of children with the Post Hospitalization Behaviour Questionnaire for Ambulatory Surgery (PHBS-AS).
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
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
Acronym: premidazolam
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04322734
Autism Spectrum Disorder, Brain Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT06309251
Autism Spectrum Disorder, Brain Diseases
Milan, MI, Italy
View Trial DetailsNCT07277101
Autism Spectrum Disorder, Autistic Disorder
Shanghai, China
View Trial DetailsNCT06361147
Autism Spectrum Disorder, Child Development Disorders, Pervasive
Heraklion, Crete, Greece
View Trial Details