NCT04928352

Nebulized Bupivacaine Analgesia for Cleft Palate Repair

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive; Nebulized plain Bupivacaine 0.50% 0.50 mg.kg-1 (Group B) or same volume of saline placebo (Group C).

Conditions

• Cleft Palate

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
OTHER	0.9% saline	Preoperative nebulized same volume of saline placebo

Timeline

• Start date: 2021-06-14
• Primary completion: 2026-08-10
• Completion: 2026-09-20
• First posted: 2021-06-16
• Last updated: 2026-01-02

Locations

1 site across 1 country: Egypt