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

NCT05681572 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Anesthesia

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Christophe DADURE, PHD · Hospital of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2026-10-18
Completion
2027-10-18

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681572 on ClinicalTrials.gov