Pain Control Using Nebulized Bupivacaine After Cleft Palate Repair in Children Aged 1 to 7 Years A Randomized Double-Blind Study

What this Trial Is About

Researchers are evaluating the use of nebulized bupivacaine, a local anesthetic, as a preemptive pain relief method for children undergoing cleft palate repair. This Phase 3 randomized, double-blind controlled trial aims to compare the safety and effectiveness of this treatment with a saline placebo in children aged 1 to 7 years. The study is sponsored by Assiut University and focuses on improving postoperative pain management in pediatric patients undergoing this surgery. Participants will be randomly assigned to one of two groups, each with 30 children. One group will receive nebulized bupivacaine at a concentration of 0.5% and a dose of 0.5 mgkg before surgery, while the other group will receive a similar volume of nebulized saline as a placebo. Both treatments are delivered preoperatively in opaque bags labeled as study drug to maintain blinding. The trial is designed to carefully monitor and compare the effects of the active drug versus the placebo. Childrens guardians will provide informed consent before participation. During the study, researchers will monitor the total amount of rescue pain medication used during the 24 hours following surgery, the childrens pain levels using the FLACC scale, and the time until the first request for rescue analgesics. The study includes thorough safety monitoring and aims to complete follow-up assessments within the first day after surgery, providing detailed information on pain control and medication needs.

Nebulized Bupivacaine Analgesia for Cleft Palate Repair