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Clinical Trial 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.


Clinical Trial Description

Surgery is a stressful experience in children with preoperative and postoperative anxiety. For preschooler undergoing surgery, anxiety is the highest in the preoperative period. Most of studies have been conducted on young children (< 7yrs old) to show the relationship between preoperative anxiety and emergence of delirium and postoperative maladaptive behavioral changes. Sedative and anxiolytic medication is frequently used in children to reduce anxiety and postoperative maladaptive experiences. Nevertheless, little clinical evidence supports is benefit for children older than 7 years. Treating anxiety is not necessarily associated with better experience in all children because premedication causes postoperative sedation, amnesia and cognitive impairment. The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience using self-report questionnaire. Patients are randomized to 2 groups to received pharmacologic premedication or placebo. For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05681572
Study type Interventional
Source University Hospital, Montpellier
Contact Sophie BRINGUIER, PHD
Phone 0467338661
Email s-bringuierbranchereau@chu-montpellier.fr
Status Recruiting
Phase Phase 3
Start date April 18, 2023
Completion date March 1, 2026

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