Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 1 Year to 7

Nebulized bupivacaine for pain relief in children undergoing cleft palate repair

Official title: Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial

Run by Assiut University · NCT04928352 · Data updated 2026-11-12

This study is testing if a new way of giving pain relief with a mist of bupivacaine can help children feel less pain during and after cleft palate surgery.

More Cleft Lip and Palate trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages1 Year to 7 Years
SexAll
Enrollment60 (estimated)
SponsorAssiut University
Academic / other
Locations1 site (Asyut, Assuit)
StatusRecruiting
StartedJune 14, 2021
Main results expectedNovember 10, 2026
Study endsNovember 20, 2026
Registry record updatedSeptember 9, 2026
Trial IDNCT04928352 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 1-7 years with ASA physical status I-II scheduled for elective cleft palate repair.

Probably not a fit

Patients with coronary artery disease, hypertension, developmental delay, or allergies to the study drug may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of nebulized bupivacaine as a preemptive analgesic in children undergoing cleft palate repair. Participants will be randomly assigned to receive either two different doses of bupivacaine or a saline placebo. The study aims to determine the optimal dosage for pain management during and after the surgical procedure. Written informed consent will be obtained from the guardians of the children involved in the trial.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management for children undergoing cleft palate repair.

How similar studies have gone: Other studies have shown promising results with local anesthetics for similar surgical procedures, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
* Elective cleft palate repair ± cleft lip surgery under general anesthesia .

Exclusion Criteria:

* Coronary artery disease
* Hypertension
* Developmental delay
* Allergy to study drug

Where it's running

  • Assiut university hospital
    Asyut, Assuit, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.