Plain-English translation of NCT05681572 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether two different calming medications— or —given before surgery can help children ages 7 to 17 feel less anxious and have a better overall experience. Some children get one of these medications, while others receive a placebo (a harmless syrup with no medicine). Researchers want to understand if treating anxiety before surgery actually makes children feel better afterward, since sometimes the medications can cause drowsiness or memory gaps.
Surgery is naturally scary for children, and anxiety before and after an operation is very common. While doctors often use calming medications to reduce this anxiety, there isn't strong evidence that this actually improves how children feel, especially for kids older than 7. This trial will help doctors figure out whether this medication is truly helpful or if it causes more problems than it solves.
You likely qualify if…
You likely don't qualify if…
About 45 minutes before your surgery, you will drink either a calming medication or a harmless placebo syrup. You'll then proceed with your normal surgery as planned. After surgery, you'll answer questions about how you felt before, during, and after the operation—about your anxiety, any scary thoughts, and how you're feeling overall. There are no extra visits or procedures beyond your regular surgical care.
AI-generated summary from trial data · Jul 17, 2026 · Not medical advice
France
Phase
Large-scale testing
Sponsor
University Hospital, Montpellier
Enrollment target
~1,000 participants
Started
April 2023
Primary completion
October 2027
Age range
7 Years – 18 Years
Last updated on clinicaltrials.gov in July 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Sophie BRINGUIER, PHD
Hospital of Montpellier
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.