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Clinical Evaluation of Oral Midazolam Containing Cyclodextrin in Pediatric Magnetic Resonance: A Retrospective Cohort
Rossella Garra1, Alessandra Piersanti1, Miryam Del Vicario1
1Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
Insights
Midazolam/γ-cyclodextrin oral formulation effectively reduced anxiety in children undergoing MRI scans, improving cooperation and decreasing anesthetic needs. This study highlights its potential for better pediatric procedural experiences.
Area of Science:
- Pediatric Anesthesiology
- Radiology
- Pharmacology
Background:
- Pediatric anxiety before MRI impacts behavioral outcomes.
- Midazolam/γ-cyclodextrin is a potential anxiolytic agent.
Purpose of the Study:
- Evaluate the anxiolytic efficacy of midazolam/γ-cyclodextrin in children undergoing MRI.
- Assess its impact on behavior, drug acceptance, and anesthetic requirements.
Main Methods:
- Retrospective review of 100 pediatric MRI cases (Feb-Jul 2022).
- Comparison between midazolam/γ-cyclodextrin premedication and control groups.
- Evaluation of facemask acceptance, separation anxiety, and anesthetic use.
Main Results:
- 58% vs 22% facemask acceptance in premedicated vs control groups.
- No restraints needed for separation in premedicated group vs 18% in control.
- Reduced sevoflurane requirement and lower emergence agitation (46% vs 66%).
Conclusions:
- Midazolam/γ-cyclodextrin demonstrates good acceptance and anxiolytic effects.
- It reduces anesthetic needs in pediatric MRI.
- This formulation offers a promising approach for managing pre-procedural anxiety in children.
Background:
Reducing a child's level of anxiety before magnetic resonance imaging (MRI) procedures allows for better behavioral outcomes. The aim of this retrospective study was to evaluate anxiolytic efficacy of Midazolam/γ-cyclodextrin oral formulation.
Methods:
We retrospectively reviewed 100 medical charts of children who, between 1 February and 31 July 2022, underwent MRI under general anesthesia with or without premedication with midazolam/γ-cyclodextrin. Primary outcome was comparison of behavior to facemask positioning, while secondary endpoints were degree of drugs acceptance, anxiolytic effect evaluation, child's behavior on separation, and sevoflurane need.
Results:
Facemask positioning was accepted by 58% of the midazolam/γ-cyclodextrin group compared to 22% of children in the control group. The rate of acceptance was >90%. At the moment of separation from parent, none of the premedicated children needed to be restrained compared to 18% in the control group. A lower percentage of sevoflurane was needed for eye-closure at induction of anesthesia and for anesthesia maintenance. At emergence from anesthesia, 46% of children in the premedicated group compared to 66% of children in the control group showed transient agitation.
Conclusions:
Midazolam/γ-cyclodextrin showed a good profile of acceptance, satisfactory anxiolytic properties, and reduced need for anesthetics when administered to children before MRI under general anesthesia.
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