---
title: "EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY"
nct_id: NCT05946928
overall_status: COMPLETED
sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
study_type: OBSERVATIONAL
primary_condition: Autism Spectrum Disorder
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05946928.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05946928"
ct_last_update_post_date: 2023-07-17
last_seen_at: "2026-05-12T06:31:32.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05946928](https://clinicaltrials.gov/study/NCT05946928)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- **Conditions:** Autism Spectrum Disorder, Premedication, Brain Neoplasms, Brain Pathology, Growth Retardation
- **Start Date:** 2022-03-01
- **Completion Date:** 2022-12-15
- **CT.gov Last Update:** 2023-07-17

## 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

- **Minimum age:** 1 Year
- **Maximum age:** 10 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Ozased group** — 50 patients premedicated with OZALIN® / OZASED®
- **Control group** — 50 patients who did not receive any premedication

## Primary Outcomes

- **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

- **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: procedure (at induction of general anesthesia))_
- **patient degree of acceptance of the administered premedication** _(time frame: 30 minutes before induction of general anesthesia)_
- **evaluation of OZALIN® / OZASED® anxiolytic efficacy** _(time frame: 30 minutes after premedication administration)_
- **child's behavior on separation from the parent** _(time frame: baseline (before induction of general anesthesia))_
- **occurrence of delirium at the emergence from anesthesia** _(time frame: at emergence of anesthesia procedure)_
- **evaluation of behavioural changes seven days after the procedure, between the two groups.** _(time frame: 7 days after the magnetic resonance Imaging)_

## Locations (1)

- Fondazione Policlinico Agostino Gemelli IRCCS, Rome, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fondazione policlinico agostino gemelli irccs|rome||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05946928.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05946928*  
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