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RECRUITING
NCT05681572
PHASE3

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

DRUG

Midazolam

45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.

DRUG

Dexmedetomidine

45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.

DRUG

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