Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Launched by ASSIUT UNIVERSITY · Jun 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help manage pain in children undergoing surgery to repair a cleft palate. Researchers are testing a medication called bupivacaine, which is a strong local anesthetic, given through a nebulizer (a device that turns liquid medicine into a mist) in two different doses. The goal is to see which dose works better to reduce pain before and after the surgery.

To be eligible for this study, children between the ages of 1 and 7 who are healthy enough for surgery (classified as ASA I-II) can participate. This includes those who are having elective surgery for cleft palate repair, with or without cleft lip surgery, under general anesthesia. Children with certain health issues, like heart disease or allergies to the study medication, cannot join. Participants can expect to receive the nebulized bupivacaine before their surgery, and the study will monitor their pain levels and any side effects to ensure safety. This trial is important because it may lead to better pain management options for young children undergoing these common procedures.

Gender

ALL

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