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Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Minitablet) in Clinical Practice

NCT05894057 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-10-24

No results posted yet for this study

Summary

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.

Conditions

  • Medication Palatability

Interventions

OTHER

Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB

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.

Sponsors & Collaborators

  • University Children's Hospital Basel

    lead OTHER

Principal Investigators

  • Svetlana Beglinger, Dr. med. · University of Basel Children's Hospital (UKBB)

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894057 on ClinicalTrials.gov