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Timing of anxiety drug may ease stress in Kids' surgery

NCT ID NCT07622641

Symptom relief Sponsor: Erzurum City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving midazolam before surgery or during anesthesia works better for children having their tonsils removed. One hundred kids aged 3-10 will be randomly assigned to receive the drug either as a drink 30 minutes before surgery or through an IV during anesthesia. The researchers will measure stress hormones, anxiety, pain, and parent satisfaction to find the best approach.

What this could mean

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

Active substance
Midazolam
What this could lead to
If it works, this could help doctors choose the best time to give midazolam to reduce stress and improve recovery in children having tonsil surgery.
What could go wrong
This is a small, early-stage trial with only 100 children. The results may not apply to all kids or surgeries, and midazolam can cause drowsiness or breathing issues.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

3 to 10 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: * Children aged 3-10 years, * Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy, * American Society of Anesthesiologists (ASA) physical status I-II, * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * Children younger than 3 years or older than 10 years, * American Society of Anesthesiologists (ASA) physical status greater than II, * Known allergy to apple or apple-derived products, * Known allergy or hypersensitivity to benzodiazepines, * Presence of developmental delay, * History of neuropsychiatric disorders, * Current or recent use of corticosteroids, * Expected or actual surgical duration longer than 90 minutes, * Refusal of participation by parents or legal guardians

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Adenotonsillectomy Postoperative pain Preoperative anxiety Surgical stress response

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erzurum City Hospital

    Erzurum, Yakutiye, 25240, Turkey (Türkiye)

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