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Can a single injection calm infants waking from anesthesia?

NCT ID NCT05091242

Symptom relief Sponsor: Rigshospitalet, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a single dose of clonidine, given during surgery, can reduce emergence agitation—crying, thrashing, and confusion—when infants wake from anesthesia. The study includes infants aged 3 to 12 months undergoing general anesthesia with sevoflurane. Half receive clonidine, half receive a placebo, and researchers monitor agitation, pain, and side effects during recovery.

What this could mean

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

Active substance
Clonidine injection (3 mcg/kg) given once during surgery
What this could lead to
If effective, a single dose of clonidine could become a standard way to prevent distressing post-anesthesia agitation in infants, improving recovery comfort.
What could go wrong
This is a mid-stage trial, and clonidine may not reduce agitation in all infants. Possible side effects include low blood pressure or slow heart rate, and results may not apply to all surgeries.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 336 people

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

Started

Oct 2021

Expected to finish

Jan 2028

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 12 months

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: * Paediatric patients (male and female), aged 3- ≤ 12 months * Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional * The legally acceptable representative for the study participant provides written informed consent/assent for the trial Exclusion Criteria: * ASA \>2 * Cardiac, neuro and trauma surgery * Ex-premature (\<37 weeks) • Premedication with clonidine * Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure * Critical illness incl. hemodynamic instability (inotropic drugs needed) * Bleeding requiring transfusion prior to scheduled anaesthesia * Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid * Malignant disease * Cardiac disease incl. arrhythmia * Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient * Mental retardation * Neurological disease including symptoms similar to emergence agitation * Has or is suspected of having a family or personal history of malignant hyperthermia * Has or is suspected of having an allergy to study treatment or its excipients * Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data * Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium Pain, Postoperative Postoperative Nausea and Vomiting

As listed by the trial registrant

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

Emergence delirium

How to take part

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

  1. The places running it

    2 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

  • Copenhagen University Hospital, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Perth Children's Hospital, Department of Anaesthesia and Pain Medicine

    RECRUITING

    Perth, Nedlands, WA 6009, Australia

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