Medication PalatabilityNCT05894057
Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Minitablet) in Clinical Practice
An observational study of Medication Palatability, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Medication Palatability
- What is being tested?
- Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jun 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel Children's Hospital (UKBB)
Basel, 4056
Svetlana Beglinger, Dr. med., +41 61 7042550, svetlana.beglinger@ukbb.ch
Svetlana Beglinger, Dr. med.
About this study
Official title: Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice
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.
Read the 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
- Being tested
- Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB
- Keywords
- midazolam, midazolam oral syrup, midazolam rectal suppository, midazolam oro- dispersible mini-tablet, drug-adherence in pediatrics, pediatric sedation management, anxiolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBBOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB | |
| 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. Receives: Other: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's acceptance after intake of midazolam rated by research staff
4-point acceptability scale (from "child liked the medication" to "child did not like the medication") rated by research staff
Measured: one time assessment at baseline
Children's acceptance after intake of midazolam rated by the pediatric patients
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.
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start6 Jun 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication PalatabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana Beglinger, Dr. med., Principal investigator, University of Basel Children's Hospital (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894057
- Sponsor's protocol ID
- 2023-00302; ks22Pfister2
- Other IDs
- 2023
- Status last verified
- Oct 2023
- First submitted
- 30 May 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Understand Acceptability of Various Available Midazolam Formulations (Syrup, Rectal Suppository, Oro-dispersible Tablet) in Clinical Practice
- ClinicalTrials.gov ID
- NCT05894057
- Acronym / sponsor ID
- 2023-00302; ks22Pfister2
- Conditions
- Medication Palatability
- Keywords
- midazolam, midazolam oral syrup, midazolam rectal suppository, midazolam oro- dispersible mini-tablet, drug-adherence in pediatrics, pediatric sedation management, anxiolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (reference: midazolam oral syrup or rectal suppository formulations) | – | Other: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBBOral syrup or rectal suppository formulation of midazolam prescribed in the Anesthesiology Unit or Emergency Unit of UKBB as current reference formulations in clinical routine. |
| Group 2 (alternative: midazolam oro- dispersible mini-tablet (OMDT) formulation) | – | Other: Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBBODMT formulation of midazolam prescribed in the Anesthesiology or Emergency Unit at UKBB as a recently introduced alternative formulation in clinical routine. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection on acceptability of midazolam administration by 2- to 10-year-old pediatric patients at UKBBOn 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. | Other | Group 1 (reference: midazolam oral syrup or rectal suppository formulations), Group 2 (alternative: midazolam oro- dispersible mini-tablet (OMDT) formulation) |
Primary outcome
Children's acceptance after intake of midazolam rated by research staff
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Beglinger, Dr. med. principal investigator
University of Basel Children's Hospital (UKBB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Palatability, run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Beglinger, Dr. med. (+41 61 7042550, svetlana.beglinger@ukbb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's acceptance after intake of midazolam rated by research staff (time frame: one time assessment at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.