Clinical trial NCT05894057: Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Minitablet) in Clinical Practice
Official title: Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medication Palatability
Keywords: midazolam
midazolam oral syrup
midazolam rectal suppository
midazolam oro- dispersible mini-tablet
drug-adherence in pediatrics
pediatric sedation management
anxiolysis
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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. .

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)

Primary outcomes:
measure: Children's acceptance after intake of midazolam rated by research staff
timeFrame: one time assessment at baseline
measure: Children's acceptance after intake of midazolam rated by the pediatric patients
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel Children's Hospital (UKBB)
Study officials:
affiliation: University of Basel Children's Hospital (UKBB)
name: Svetlana Beglinger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: