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

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.

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).

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