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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Status | Recruiting |
| Started | June 14, 2021 |
| Main results expected | November 10, 2026 |
| Study ends | November 20, 2026 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT04928352 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
- Study coordinator: Omar Soliman, MD
- Email: omarmakram347@yahoo.com
- Phone: 01101266040
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effect of a cleft-adapted bottle with a unidirectional valve on milk intake in infants with cleft palate
This study tests whether using a cleft-adapted bottle with a unidirectional valve helps infants with cleft palate take in more milk than a standard bottle.
-
Palatoplasty techniques using PRF and antibiotic-loaded PRF in cleft palate
This trial tests whether adding autologous PRF or gentamicin-loaded PRF to primary palatoplasty helps kids with unilateral or bilateral cleft palate heal better and have fewer fistulas than standard surgery.
-
Comparing pain relief methods after cleft palate surgery in children
This study is testing whether short-acting or long-acting pain medications work better for managing pain in young children after cleft palate surgery.
-
Furlow palatoplasty with buccal flap for speech in children with cleft palate
This project compares two palate repair methods to see if Furlow palatoplasty with a buccal myomucosal flap leads to better speech than two-flap palatoplasty in children aged 3–5 with nonsyndromic cleft palate.
-
Comparing two pain management techniques for children undergoing palate surgery
This study is testing two different pain management techniques for kids aged 6-18 who are having palate surgery to see which one helps them feel less pain after the operation.
-
Analyzing Velopharyngeal Motor Skills in Children with Cleft Palate Using MRI
This study is trying to see how well the muscles in the throat work in children with cleft palate to help understand why some still have trouble speaking after surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.