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Can a nerve block Add-On calm pain and agitation after cleft palate repair?

NCT ID NCT06100315

Symptom relief Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether adding nalbuphine to a standard numbing medicine improves pain control and reduces agitation in children aged 1 to 7 after cleft palate repair. Half of the 60 participants receive the standard nerve block with bupivacaine alone, while the other half receive bupivacaine plus nalbuphine. Researchers measure pain using a standard scale during the first day after surgery and also track how calm or agitated the children become as they wake up from anesthesia.

What this could mean

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

Active substance
nalbuphine added to bupivacaine, given as a nerve block
What this could lead to
If it works, this could point toward a safer, more effective way to manage pain and reduce agitation in young children after cleft palate surgery.
What could go wrong
This is a small, early-stage trial, and the results may not apply to all children. Adding nalbuphine could also carry risks such as extra sedation or allergic reactions.

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

60 people

The number who actually took part.

Started

Jul 2023

Finished

Jan 2026

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

12 months to 7 years

Sex

Anyone

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: 1. Age 1 to 7 years. 2. Both genders. 3. American society of anesthesiologists (ASA) physical state I-II. 4. Children undergoing palate surgeries. Exclusion Criteria: 1. Guardians' refusal 2. History of developmental delay or mental retardation. 3. Children with any co-morbidities. 4. Skin infection at the site of injection. 5. Bleeding diathesis. 6. Known allergy to any drugs used in this study.

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Conditions

The condition(s) this trial relates to.

cleft lip/palate

As listed by the trial registrant

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

Complication following peripheral nerve block

Contacts and locations

Locations

  • Mohamed Fathy Mostafa

    Asyut, Egypt

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