New oral sedative studied in children to improve pre-surgery dosing
NCT ID NCT03639428
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a new oral form of midazolam (ADV6209) is processed in the body of children aged 6 months to 17 years before surgery. 37 children received a single dose based on their weight. Researchers measured drug levels in the blood to understand how age affects clearance and to support future dosing recommendations. The goal was not to test effectiveness but to gather pharmacokinetic data.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- midazolam (oral solution ADV6209)
- What this could lead to
- If successful, this could lead to better dosing guidelines for midazolam in children, making pre-surgery sedation safer and more predictable.
- What could go wrong
- This is a small, early-phase study (37 children) focused on drug levels, not on proving effectiveness or safety. Results may not apply to all children or clinical settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
37 people
The number who actually took part.
- Started
-
Jun 2011
- Finished
-
Nov 2017
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The planned enrollment is 36 children, stratified in two groups: 24 children between 6 months and 11 years, and 12 children between 12 and 17 years. Age is considered in years past by the date of inclusion. Children aged between 6 months and 11 years old should be homogenous in both age groups 6-23 months and 2-11 years. For example, at least 4 children in the 6-23 month age group will be recruited. Children likely to be included will be hospitalized in the pediatric surgery department at Amiens University Hospital. Children who will be included in this study will not be able to participate in another study within 3 months of their inclusion in this study.
- Ages
-
6 months to 18 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Child (boy or girl) for whom surgery under general anesthesia is scheduled. * Child aged 6 months to 17 years old. * Child with a body mass index between the 3rd and 97th percentile. * Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test. * Child whose parents / legal representative (s) agree to sign a consent form. * Child whose opinion / agreement was / tried to be collected. * Child and parents / legal representative (s) being ready and able to participate in the study, understanding and undertaking to respect the study procedures throughout the duration of the study. * Child enrolled in a social security scheme. Exclusion Criteria: * Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study. * Child with respiratory disease (severe respiratory failure, acute respiratory depression). * Child with heart disease. * Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux. * Child with growth disorders or abnormal weight-of-weight. * Child taking Cytochrome P450 Interactions Within 60 Days of Inclusion in the study. * Child with kidney failure, liver failure, history of myasthenia gravis, or neurological disease. * Pregnant or lactating girl. * Child who has a known human immunodeficiency virus (HIV) infection, or active hepatitis B, or active hepatitis C. * A child who could present any condition that may prevent his participation in the study, according to the judgment of the investigator.
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