Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Recruiting · NCT05681572 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
7 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Uhmontpellier - Montpellier, Montpellier, France