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Opioid-Free pain block may be better for kids after surgery

NCT ID NCT06862271

Symptom relief Sponsor: Miray Gözde Özdemir 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 120 boys aged 4 months to 12 years having urogenital surgery. It compared an opioid-free caudal block (using bupivacaine) with an opioid-supplemented penile nerve block (using fentanyl) to see which provides better pain control and less post-surgery delirium. Researchers measured pain, agitation, and recovery times like walking and urination.

What this could mean

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

Active substance
bupivacaine (caudal block) and fentanyl (penile block)
What this could lead to
If successful, this could show that an opioid-free approach works as well or better for pain and delirium after pediatric urogenital surgery, potentially reducing opioid use in children.
What could go wrong
This is a small, completed study (120 children) comparing two existing techniques. Results may not apply to all hospitals or surgeries, and neither method is new—so no breakthrough is expected.

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.

Participants

120 people

The number who actually took part.

Started

Apr 2025

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

4 months to 12 years old male pediatric population

Ages

4 months to 12 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 4 months - 12 years old male patient * Acceptance of participation in the study * Patients Planned for Urogenital Surgery * ASA I-II Patients Exclusion Criteria: * \<4 months, \>12 years male patient * Female patient * Not accepted to be included in the study * ASA status III-IV * History of bleeding disorder * Spinal cord disease * Obstructive sleep apnea * Developmental delay * Behavioral disorder * Allergy to any drug in the protocol

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Conditions

The condition(s) this trial relates to.

agnosia delirium pain agnosia

As listed by the trial registrant

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

Analgesia Caudal block Fentanyl Pediatric delirium Pediatric urologic surgeries

Contacts and locations

Locations

  • Ankara Etlik City Hospital

    Yenimahalle, Ankara, 06100, Turkey (Türkiye)

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