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Could a Pre-Surgery sedative improve Kids' hospital experience?

NCT ID NCT05681572

Symptom relief Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial investigates whether giving children aged 7 to 17 a sedative before general anesthesia improves their surgical experience. Participants receive either midazolam, dexmedetomidine, or a placebo before surgery. The study measures anxiety, pain, and overall satisfaction to see if premedication is beneficial for older children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a sedative drug (midazolam or dexmedetomidine) given before anesthesia
What this could lead to
If successful, this could show that giving a sedative before surgery improves children's overall experience and reduces anxiety.
What could go wrong
This is a single trial, and results may not apply to all children or settings. The sedatives can cause side effects like drowsiness or delayed waking.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject over 7 and under 18 years of age * Subjects who are scheduled for surgery * Subject who will be under general anesthesia * Subject able to complete a self-questionnaire in French Exclusion Criteria: * Subject who has already participated in the pediaPREM study * Subject with a treated anxiety disorder * Subject with cognitive disorders * Subject suffering from chronic pain (outside the operated area) * Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment * Subject suffering from mental retardation * Subjects receiving psychotropic treatment * Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.) * Subject with a contra-indication to midazolam and its excipients * Subject with a contra-indication to dexmedetomidine and its excipients * Subjects who need to receive intravenous alpha agonist in perioperative * Subjects requiring emergency intervention * Subjects requiring preoperative hypnosis * Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...) * Subject having had a surgical intervention in the month preceding the inclusion. * Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...) * Subjects who are scheduled for surgery as part of oncology management * Pregnant or breastfeeding woman * Subject whose two parents have not signed a written informed consent * Subjects who are not affiliated with or benefiting from a social security plan

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Conditions

The condition(s) this trial relates to.

anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Uhmontpellier

    RECRUITING

    Montpellier, Montpellier, 34295, France

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