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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.
At the University Children's Hospital Basel (UKBB) in Switzerland, ~ 2500 children are referred to the Pediatric Anesthesiology Unit per year receiving midazolam sedation before surgery. Further, ~2000 children are admitted to the Pediatric Emergency Unit for procedures requiring midazolam sedation per year. Medication palatability is a key element of treatment adherence and successful therapy outcome. In a previous cross-sectional acceptability study in 2- to 10-year-old pediatric patients at UKBB, it was demonstrated that an inorganic calcium carbonate/calcium phosphate carrier material as the main excipient in an oro- dispersible mini-tablet (ODMT) formulation is safe, palatable, and highly acceptable in children. To date, no data for acceptability in terms of palatability and anxiolysis in daily preoperative practice for midazolam oral syrup, rectal suppository or ODMT formulation is available. As such the goal of this observational study is to better understand acceptability of various midazolam formulations (oral syrup, rectal suppository, ODMT) in clinical practice in 2- to 10-year-old pediatric patients at UKBB. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (reference: midazolam oral syrup or rectal suppository formulations) | Oral syrup or rectal suppository formulation of midazolam prescribed in the Anesthesiology Unit or Emergency Unit of UKBB as current reference formulations in clinical routine. |
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| Group 2 (alternative: midazolam oro- dispersible mini-tablet (OMDT) formulation) | ODMT formulation of midazolam prescribed in the Anesthesiology or Emergency Unit at UKBB as a recently introduced alternative formulation in clinical routine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB | Other | On the day of entry to the Anesthesiology Unit for an elective surgery, or before an intervention at the Emergency Unit, all children, irrespective of their participation to the present study, will receive standard midazolam dose of 0.3-0.5 mg/kg as prescribed by the treating clinician at UKBB in line with clinical practice (as oral syrup, rectal suppository or ODMT). The children's spontaneous reactions after intake of midazolam (e.g., positive comments, spitting out of medication, crying) will be observed and recorded by the research staff. Children who are able to understand the 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's acceptance after intake of midazolam rated by research staff | 4-point acceptability scale (from "child liked the medication" to "child did not like the medication") rated by research staff | one time assessment at baseline |
| Children's acceptance after intake of midazolam rated by the pediatric patients | 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. | one time assessment at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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2- to 10-year-old pediatric patients in the Pediatric Anesthesiology Unit and Pediatric Emergency Unit at the UKBB. Pediatric patients undergoing elective surgical or emergency procedures requiring anxiolysis with midazolam during clinical routine will be enrolled in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Svetlana Beglinger, Dr. med. | Contact | +41 61 7042550 | svetlana.beglinger@ukbb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Svetlana Beglinger, Dr. med. | University of Basel Children's Hospital (UKBB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel Children's Hospital (UKBB) | Recruiting | Basel | 4056 | Switzerland |
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