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

NCT ID: NCT05894057

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2023-12-31

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. .

Conditions

Medication Palatability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (reference: midazolam oral syrup or rectal suppository formulations)

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.

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

Intervention Type: OTHER

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.

Group 2 (alternative: midazolam oro- dispersible mini-tablet (OMDT) formulation)

ODMT formulation of midazolam prescribed in the Anesthesiology or Emergency Unit at UKBB as a recently introduced alternative formulation in clinical routine.

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital Basel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetlana Beglinger, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Basel Children's Hospital (UKBB)

Locations

University of Basel Children's Hospital (UKBB)

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Svetlana Beglinger, Dr. med.

Role: CONTACT

svetlana.beglinger@ukbb.ch

+41 61 7042550

Facility Contacts

Svetlana Beglinger, Dr. med.

Role: primary

svetlana.beglinger@ukbb.ch

+41 61 7042550

Other Identifiers

2023-00302; ks22Pfister2

Identifier Type: -

Identifier Source: org_study_id