NCT04928352 Nebulized Bupivacaine Analgesia for Cleft Palate Repair
| NCT ID | NCT04928352 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assiut University |
| Condition | Cleft Palate |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-06-14 |
| Primary Completion | 2026-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2021-06-14 with a primary completion date of 2026-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study we introduce a potent local anesthetic; bupivacaine 0.5% in 0.5 mg/kg dose by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.
Eligibility 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
Contact & Investigator
Omar Soliman, MD
STUDY DIRECTOR
Assiut University
Frequently Asked Questions
Who can join the NCT04928352 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 7 Years, studying Cleft Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04928352 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT04928352 currently recruiting?
Yes, NCT04928352 is actively recruiting participants. Contact the research team at omarmakram347@yahoo.com for enrollment information.
Where is the NCT04928352 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT04928352 clinical trial?
NCT04928352 is sponsored by Assiut University. The principal investigator is Omar Soliman, MD at Assiut University. The trial plans to enroll 60 participants.