Impact of Sedative and Anxiolytic Medication on Children's Experience After Anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of sedative and anxiolytic premedication on the perioperative experiences of children aged 7 to 18 undergoing general anesthesia for surgery. It aims to determine whether pharmacologic premedication, specifically midazolam or dexmedetomidine, can reduce anxiety and improve postoperative outcomes compared to a placebo. Participants will be randomly assigned to receive either the medication or placebo, and their experiences will be assessed using self-report questionnaires. The study addresses a gap in existing research regarding older children and the efficacy of premedication.

Why it matters

Who can join: the full rules

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 who are not affiliated with or benefiting from a social security plan

Where it's running

• Uhmontpellier
  Montpellier, Montpellier, France Recruiting

Study contacts

• Study coordinator: Sophie BRINGUIER, PHD
• Email: s-bringuierbranchereau@chu-montpellier.fr
• Phone: 0467338661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.