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

Autism Spectrum Disorder Clinical Trial

— premidazolam  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946928
• Other study ID #: 0032517/22
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction.	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)	30 minutes within premedication administration
Secondary	the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia	the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia;	procedure (at induction of general anesthesia)
Secondary	time to eye closure at induction of anesthesia;	time to eye closure at induction of anesthesia	procedure (at induction of general anesthesia)
Secondary	patient degree of acceptance of the administered premedication	degree of acceptance of the administered premedication	30 minutes before induction of general anesthesia
Secondary	evaluation of OZALIN® / OZASED® anxiolytic efficacy	OZALIN® / OZASED® anxiolytic efficacy was evaluated 30 minutes after premedication administration with the Ramsay sedation scale	30 minutes after premedication administration
Secondary	child's behavior on separation from the parent	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)	baseline (before induction of general anesthesia)
Secondary	occurrence of delirium at the emergence from anesthesia	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)	at emergence of anesthesia procedure
Secondary	evaluation of behavioural changes seven days after the procedure, between the two groups.	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).	7 days after the magnetic resonance Imaging