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Completed

NCT Number: NCT05946928

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction.

    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)

Secondary outcomes

  1. the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia

    Time frame: procedure (at induction of general anesthesia)

    the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia;

  2. time to eye closure at induction of anesthesia;

    Time frame: procedure (at induction of general anesthesia)

    time to eye closure at induction of anesthesia

  3. patient degree of acceptance of the administered premedication

    Time frame: 30 minutes before induction of general anesthesia

    degree of acceptance of the administered premedication

  4. evaluation of OZALIN® / OZASED® anxiolytic efficacy

    Time frame: 30 minutes after premedication administration

    OZALIN® / OZASED® anxiolytic efficacy was evaluated 30 minutes after premedication administration with the Ramsay sedation scale

  5. child's behavior on separation from the parent

    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)

  6. occurrence of delirium at the emergence from anesthesia

    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)

  7. evaluation of behavioural changes seven days after the procedure, between the two groups.

    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).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Acronym: premidazolam

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2023
Registry last updated
Jul 17, 2023

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.

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