RecruitingPhase 3NCT05681572

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

" Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.

Sponsor

University Hospital, Montpellier

Enrollment

1,000 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

Anesthesia

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.

Eligibility

Min Age: 7 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how pre-surgery sedative or anxiety-reducing medications (premedication) affect children's emotional experiences and recovery after going under general anesthesia. The goal is to improve how children are prepared for surgery and reduce anxiety and distress. **You may be eligible if...** - Your child is between 7 and 18 years old - Your child is scheduled for surgery requiring general anesthesia - Your child can complete a self-questionnaire in French **You may NOT be eligible if...** - Your child has already participated in the related pediaPREM study - Your child has a treated anxiety disorder, cognitive disorder, or mental disability - Your child takes psychotropic medications or has ADD/ADHD with treatment - Your child needs emergency surgery or surgery for cancer - Your child had surgery in the past month or will have repeat surgery within 15 days - Your child has a contraindication to midazolam or dexmedetomidine (specific pre-medications) - Both parents have not signed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMidazolam

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

DRUGDexmedetomidine

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

DRUGPlacebo

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