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Could a common Anti-Nausea drug help kids sleep better after surgery?

NCT ID NCT07777276

Symptom relief Sponsor: Telethon Kids Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial asks whether two standard anti-nausea medications given during anesthesia—dexamethasone and ondansetron—affect children's sleep, behavior, and recovery after surgery. About 500 children aged 2-15 having minor procedures will be randomly assigned to receive one of the two drugs, without knowing which. Parents will report on sleep quality and recovery for a week after surgery, and some children will also wear monitors to track sleep before and after.

What this could mean

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

Active substance
Dexamethasone (IV) or Ondansetron (IV), given during anesthesia to prevent postoperative nausea and vomiting
What this could lead to
If one drug is found to disturb sleep less, it could become the preferred choice for children undergoing surgery, improving their recovery and comfort.
What could go wrong
This is a phase 4 trial, but the effects on sleep are not yet proven. Results may vary by child, and the study only looks at short-term recovery, not long-term outcomes.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 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

Aug 2029

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

2 to 15 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 2 - 15 years, * Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively * ASA I or III Exclusion Criteria: * Currently taking regular dexamethasone or ondansetron * Currently taking regular steroids, including inhaled corticosteroids * Anaesthetic plan to give dual PONV prophylaxis * Known hypersensitivity to the active substance or to any of the excipients listed * Language barriers impeding data collection * Department for Child Protection and Family Support is involved in their care * Planned admissions to the Paediatric Intensive Care Unit (PICU) * Oncology patients * Severe developmental delay * ASA III or above * Significant cardiorespiratory conditions

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Conditions

The condition(s) this trial relates to.

insomnia Postoperative Nausea and Vomiting

As listed by the trial registrant

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

Anaesthesia Paediatric surgery Postoperative behaviour Postoperative nausea and vomiting (PONV) Postoperative recovery in children Postoperative sleep quality

How to take part

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

  1. The places running it

    3 sites in 2 countries. 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

  • Hospital das Clinicas

    São Paulo, São Paulo, Brazil

  • Perth Children's Hospital

    Perth, Western Australia, 6009, Australia

  • Santa Casa de Misericórdia de Ribeirão Preto

    São Paulo, São Paulo, Brazil

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