Medication Palatability
Conditions
Keywords
midazolam, midazolam oral syrup, midazolam rectal suppository, midazolam oro- dispersible mini-tablet, drug-adherence in pediatrics, pediatric sedation management, anxiolysis
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. .
Interventions
OTHERData 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.
Sponsors
University Children's Hospital Basel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Contacts
Primary ContactSvetlana Beglinger, Dr. med.
Outcome results
None listed