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Could a drug combo make Kids' foot surgery less painful?

NCT ID NCT07289620

Symptom relief Sponsor: Poznan University of Medical Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding dexamethasone, dexmedetomidine, or both to a standard numbing shot can make pain relief last longer after foot or ankle surgery in children aged 3 to 12. About 120 kids will get one of three combinations, and neither they nor their doctors will know which. The goal is to see if the combo reduces the need for extra pain medicine and improves comfort.

What this could mean

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

Active substance
dexamethasone and dexmedetomidine
What this could lead to
If it works, this could point toward a better way to manage pain after foot surgery in children, reducing the need for strong painkillers.
What could go wrong
This is a small, early-stage study (120 children) comparing existing drugs, so results may not apply to all patients. The combination might not work better than either drug alone.

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 120 people

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

Started

Jan 2026

Expected to finish

Jan 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 12 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 to 12 years. * Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia. * ASA physical status I-III. * Ability of parents or legal guardians to understand the study procedures and provide written informed consent. * Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery. Exclusion Criteria: * Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures. * Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications. * Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory). * Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia. * Local infection, inflammation, or skin lesions at the planned block site. * Severe cardiac, hepatic, renal, or respiratory disease that, in the investigator's opinion, increases the risk of study participation. * History of clinically significant arrhythmias, severe bradycardia, or second/third degree atrioventricular block not treated with a pacemaker. * Developmental delay or severe cognitive impairment that precludes reliable pain assessment or follow-up. * Chronic use of opioid analgesics or sedatives (≥ 2 weeks of daily use before surgery). * Participation in another interventional clinical trial within the last 30 days. * Any other condition considered by the investigator to interfere with protocol adherence, safety monitoring, or reliable outcome assessment.

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Conditions

The condition(s) this trial relates to.

Foot Diseases

As listed by the trial registrant

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

Ankle disease Foot diseases

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

  • Poznan University of Medical Sciences

    RECRUITING

    Poznan, 62-701, Poland

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