Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Anesthesia
In brief
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.
Key facts
- Study ID
- NCT05681572
- Run by
- University Hospital, Montpellier
- People needed
- 1000
- Starts
- 2023-04-18
- Expected to finish
- 2027-10-18
- Last updated by the study team
- 2026-07-17
Who can join
Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify 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
- 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 is running
- Uhmontpellier — Montpellier, Montpellier, France (enrolling)
Full record on ClinicalTrials.gov
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