RecruitingPhase 3

Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia

France1,000 participantsStarted 2023-04-18

Plain-language summary

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.

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject over 7 and under 18 years of age * Subjects who are scheduled for surgery * Subject who will be under general anesthesia * Subject able to complete a self-questionnaire in French Exclusion Criteria: * 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 * Subjects 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 * Subjects who need to receive intravenous alpha agonist in perioperative * Subjects requiring emergency intervention * Subjects 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...) * Subjects 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 * Subjects w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EVANpedia Score

Timeframe: from the day of surgery up to the day one after surgery

Trial details

NCT IDNCT05681572

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-18

Contact for this trial

Sophie BRINGUIER, PHD

0467338661 s-bringuierbranchereau@chu-montpellier.fr

View on ClinicalTrials.gov More Anesthesia trials