Understanding how children accept different forms of midazolam medication

Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice

This study is trying to see which forms of midazolam medicine, like syrup or mini-tablets, kids aged 2 to 10 like best to help them feel comfortable before surgery.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 2 Years to 10 Years
• Sex: All
• Sponsor: University Children's Hospital Basel (other)
• Locations: 1 site (Basel)
• Trial ID: NCT05894057 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the acceptability of various midazolam formulations, including oral syrup, rectal suppository, and oro-dispersible mini-tablets, among pediatric patients aged 2 to 10 years at the University Children's Hospital Basel. The study aims to gather data on medication palatability, which is crucial for treatment adherence and successful outcomes. Approximately 2500 children are referred annually for midazolam sedation before surgery, and this study seeks to fill the gap in knowledge regarding the acceptability of these formulations in clinical practice. Non-invasive scoring methods will be used to assess how well these formulations are received by the children.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 9 years scheduled for elective or ambulatory surgery requiring midazolam sedation.

Not a fit: Patients who are critically ill or have neurological impairments that affect their ability to assess palatability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve medication adherence and overall treatment outcomes for pediatric patients requiring sedation.

How similar studies have performed: Previous studies have shown success in assessing medication acceptability in pediatric populations, but this specific approach to midazolam formulations is novel.

Eligibility criteria

Inclusion Criteria:

* Children from 2 years (meaning 2 years 0/12 months) to younger than 10 years (meaning 9 years 12/12 months) of age at the time of surgery
* Children scheduled for ambulatory or elective surgery or for procedures requiring anxiolysis at the UKBB
* Children qualifying as American Society of Anesthesiologists (ASA) 1 or ASA 2 patients
* Clinically indicated administration of midazolam oral syrup, rectal suppository or ODMT
* Parent or legal guardian has been informed about the study and has signed the Informed Consent Form

Exclusion Criteria:

* Children qualifying as ASA 3 and above patients
* Children arriving at the emergency ward in a critically ill condition which needs immediate intervention (i.e. American Thoracic Society (ATS) Score 1 and 2) and no tolerance for time delay due to informed consent.
* Difficulty in assessing palatability due to neurological impairments
* Hypersensitivity to midazolam, other benzodiazepines, or any formulation excipients
* Hypersensitivity to cherries (syrup)

Where this trial is running

Basel

• University of Basel Children's Hospital (UKBB) — Basel, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Svetlana Beglinger, Dr. med. — University of Basel Children's Hospital (UKBB)
• Study coordinator: Svetlana Beglinger, Dr. med.

Conditions: Medication Palatability, midazolam, midazolam oral syrup, midazolam rectal suppository, midazolam oro- dispersible mini-tablet, drug-adherence in pediatrics, pediatric sedation management, anxiolysis