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

Last updated: October 23, 2023
Sponsor: University Children's Hospital Basel
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT05894057
2023-00302; ks22Pfister2
  • Ages 2-10
  • All Genders

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.

Eligibility Criteria

Inclusion

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 requiringanxiolysis 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 orODMT
  • Parent or legal guardian has been informed about the study and has signed the InformedConsent Form

Exclusion

Exclusion Criteria:

  • Children qualifying as ASA 3 and above patients
  • Children arriving at the emergency ward in a critically ill condition which needsimmediate intervention (i.e. American Thoracic Society (ATS) Score 1 and 2) and notolerance 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)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB
Phase:
Study Start date:
June 06, 2023
Estimated Completion Date:
December 31, 2023

Study 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. .

Connect with a study center

  • University of Basel Children's Hospital (UKBB)

    Basel, 4056
    Switzerland

    Active - Recruiting

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