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Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice
This observational study aims to gain knowledge on how the different midazolam formulations (oral syrup, rectal suppository, ODMT) are accepted by 2- to 10-year-old pediatric inpatients and outpatients at the University Children's Hospital Basel (UKBB) in Switzerland. The present study will use non-invasive scoring to assess acceptability of the different midazolam formulations.
Details
| Lead sponsor | University Children's Hospital Basel |
|---|---|
| Status | UNKNOWN |
| Enrolment | 100 |
| Start date | 2023-06-06 |
| Completion | 2023-12 |
Conditions
- Medication Palatability
Interventions
- Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB
Primary outcomes
- Children's acceptance after intake of midazolam rated by research staff — one time assessment at baseline
4-point acceptability scale (from "child liked the medication" to "child did not like the medication") rated by research staff - Children's acceptance after intake of midazolam rated by the pediatric patients — one time assessment at baseline
Children who are able to understand the Facial Hedonic Scale (FHS) will be questioned on how they liked the medication by pointing to the appropriate face of a Facial Hedonic Scale (FHS) at the time of midazolam intake. Each face will be associated to a number from a scale to 1 (very bad) to 6 (very good). The spontaneous reactions of the patient will be recorded to identify acceptability.
Countries
Switzerland