Actively Recruiting
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Led by University Hospital, Montpellier · Updated on 2024-12-16
1000
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject over 7 and under 18 years of age
- Scheduled for surgery
- Will be under general anesthesia
- Able to complete a self-questionnaire in French
You will not qualify if you...
- Previously participated in the pediaPREM study
- Treated anxiety disorder
- Cognitive disorders
- Chronic pain outside the operated area
- Attention Deficit Disorder with or without hyperactivity or treatment
- Mental retardation
- Receiving psychotropic treatment
- Intervention reducing ability to complete self-questionnaire (e.g., neurosurgery)
- Contraindication to midazolam or its excipients
- Contraindication to dexmedetomidine or its excipients
- Need for intravenous alpha agonist perioperatively
- Emergency intervention required
- Require preoperative hypnosis
- General anesthesia for diagnostic purposes (e.g., biopsy)
- Surgery within one month before inclusion
- Iterative surgical intervention within 15 days (e.g., removal of material, burns)
- Surgery as part of oncology management
- Pregnant or breastfeeding woman
- Parents have not signed written informed consent
- Not affiliated with or benefiting from a social security plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Uhmontpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
S
Sophie BRINGUIER, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here