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

RECRUITINGPhase 3Sponsored by University Hospital, Montpellier
Actively Recruiting
PhasePhase 3
SponsorUniversity Hospital, Montpellier
Started2023-04-18
Est. completion2026-10-18
Eligibility
Age7 Years – 18 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05681572

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.

Eligibility

Age: 7 Years – 18 YearsHealthy volunteers accepted
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

Conditions2

AnesthesiaAnxiety

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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