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

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Dexmedetomidine; Midazolam

Criteria

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

Exclusion Criteria:

• Subject with a treated anxiety disorder

• Subject suffering from 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 alpha agonist in perioperative (clonidine, dexmedetomidine...)

• 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