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Pain-blocking shot for kids' cleft palate surgery never tested

NCT ID NCT04023825

Symptom relief Sponsor: Centre Hospitalier Universitaire, Amiens 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study planned to test whether a nerve block in the cheek area could reduce the need for morphine after cleft palate repair in children aged 5 months to 12 years. The experimental group would have received the nerve block, while the control group would not. However, the study was withdrawn before enrolling any participants, so no data were collected.

What this could mean

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

Active substance
suprazygomatic maxillary nerve block (local anesthetic)
What this could lead to
If it had worked, this could have pointed toward a way to reduce morphine use and improve pain control after cleft palate surgery in children.
What could go wrong
The study was withdrawn before any patients were enrolled, so no results are available. Even if it had been conducted, it was a small, early-stage trial, so the nerve block might not have proven better than standard care.

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.

Started

Jul 2019

Finished

Jul 2022

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

5 months 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 between 5 months and 12 years old * weight \>5kg * children undergoing cleft palate repair surgery with or without upper lip surgery Exclusion Criteria: * inappropriate age * weight \<5kg * abnormal blood coagulation * local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids) * local infection

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Conditions

The condition(s) this trial relates to.

cleft palate

As listed by the trial registrant

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

Cleft palate Surgery

More trials for these conditions

Other studies related to the condition(s) this trial covers.