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New treatment option for Anesthesia
Official title Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
ClinicalTrials.gov ID: NCT05681572
What this study is testing
What is Midazolam?
Midazolam is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old. The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 18
You may be able to join if
- Subject over 7 and under 18 years of age
- people who are scheduled for surgery
- Subject who will be under general anesthesia
- Subject able to complete a self-questionnaire in French
You likely can't join if
- Subject who has already participated in the pediaPREM study
- Subject with a treated anxiety disorder
- Subject with cognitive disorders
- Subject suffering from chronic pain (outside the operated area)
- Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment
- Subject suffering from mental retardation
See the full eligibility criteria
- Subject over 7 and under 18 years of age
- people who are scheduled for surgery
- Subject who will be under general anesthesia
- Subject able to complete a self-questionnaire in French
- Subject who has already participated in the pediaPREM study
- Subject with a treated anxiety disorder
- Subject with cognitive disorders
- Subject suffering from chronic pain (outside the operated area)
- Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment
- Subject suffering from mental retardation
- people receiving psychotropic treatment
- Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)
- Subject with a contra-indication to midazolam and its excipients
- Subject with a contra-indication to dexmedetomidine and its excipients
- people who need to receive intravenous alpha agonist in perioperative
- people requiring emergency intervention
- people requiring preoperative hypnosis
- Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)
- Subject having had a surgical intervention in the month preceding the inclusion.
- Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)
- people who are scheduled for surgery as part of oncology management
- Pregnant or breastfeeding woman
- Subject whose two parents have not signed a written informed consent
- people who are not affiliated with or benefiting from a social security plan
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.