Nebulized bupivacaine for pain relief in children undergoing cleft palate repair
Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
PHASE3 · Assiut University · NCT04928352
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT04928352 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-7 years with ASA physical status I-II scheduled for elective cleft palate repair.
Not a fit: Patients with coronary artery disease, hypertension, developmental delay, or allergies to the study drug may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for children undergoing cleft palate repair.
How similar studies have performed: Other studies have shown promising results with local anesthetics for similar surgical procedures, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Asyut, Assuit
- Assiut university hospital — Asyut, Assuit, Egypt (RECRUITING)
Study contacts
- Study coordinator: Omar Soliman, MD
- Email: omarmakram347@yahoo.com
- Phone: 01101266040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cleft Palate