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« Effect of sedative and anxiolytic sedation on children experience after general anesthesia » PEDIA_prem study.
EU CTIS ID: 2022-501124-23-00
What this study is testing
The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children older than 7 years old and younger than 18 years old
- Subject to undergo surgery under general anesthesia
- Subject able to complete a self-questionnaire
- Subject requiring intervention under general anesthesia
You likely can't join if
- Subject suffering from anxiety disorders
- Subject who is not affiliated with or benefiting from a social security plan
- Subject suffering from cognitive disorders
- Subject suffering from chronic pain
- Subject with ADD (Attention Deficit Disorder) with or without hyperactivity; with or without treatment
- Subjects suffering from mental retardation
See the full eligibility criteria
- Children older than 7 years old and younger than 18 years old
- Subject to undergo surgery under general anesthesia
- Subject able to complete a self-questionnaire
- Subject requiring intervention under general anesthesia
- Subject suffering from anxiety disorders
- Subject who is not affiliated with or benefiting from a social security plan
- Subject suffering from cognitive disorders
- Subject suffering from chronic pain
- Subject with ADD (Attention Deficit Disorder) with or without hyperactivity; with or without treatment
- Subjects suffering from mental retardation
- Subjects receiving psychotropic treatment
- Subjects whose ability to complete a self-administered questionnaire may be impaired by the intervention
- Subject with a contraindication to midazolam or to dexmedetomidine
- Subjects requiring peri-operative alpha agonist
- Subject who has already participated in the pediaPREM study
- Subject who needs to undergo an emergency procedure
- Subjects who need preoperative hypnosis
- Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)
- Subjects who need a neurosurgical intervention or had a surgical intervention in the month preceding inclusion.
- Subject who will have an iterative surgical intervention within 15 days (removal of material, burns, etc.)
- Subjects who are scheduled for surgery as part of oncology management
- Pregnant or breastfeeding woman
- Subject whose parent has not signed a written informed consent
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.