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

Recruiting

• Conditions: Medication Palatability
• Interventions: Other: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB

• Registration Number: NCT05894057
• Lead Sponsor: University Children's Hospital Basel

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. .

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study Start: 2023-06-06
• Study First Posted: 2023-06-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (alternative: midazolam oro- dispersible mini-tablet (OMDT) formulation)	Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB	ODMT formulation of midazolam prescribed in the Anesthesiology or Emergency Unit at UKBB as a recently introduced alternative formulation in clinical routine.
Group 1 (reference: midazolam oral syrup or rectal suppository formulations)	Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB	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.

Primary Outcome Measures

Name	Time	Method
Children's acceptance after intake of midazolam rated by research staff	one time assessment at baseline	4-point acceptability scale (from "child liked the medication" to "child did not like the medication") rated by research staff
Children's acceptance after intake of midazolam rated by the pediatric patients	one time assessment at baseline	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.

Trial Locations

Locations (1)

University of Basel Children's Hospital (UKBB); 🇨🇭 Basel, Switzerland