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Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Sponsor: University Hospital, Montpellier
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.
Official title: " Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.
Key Details
Gender
All
Age Range
7 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2023-04-18
Completion Date
2027-10-18
Last Updated
2024-12-16
Healthy Volunteers
No
Conditions
Interventions
Midazolam
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.
Dexmedetomidine
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.
Placebo
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.
Locations (1)
Uhmontpellier
Montpellier, France