A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries

Launched by CAIRO UNIVERSITY · Jun 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to give the medicine bupivacaine safely and effectively to children aged 1 to 6 years old who need planned surgeries below the belly button. Bupivacaine is used in spinal anesthesia, which numbs the lower part of the body during surgery. The study compares two ways of deciding the dose: one based on the child’s weight and the other based on their age. The goal is to see if dosing by age works as well as the usual weight-based method.

Children who are generally healthy (with no serious heart, nerve, or spine problems), are having surgeries expected to last 90 minutes or less, and whose parents agree to participate may be eligible. Once in the study, children will be randomly assigned to receive the medicine using one of the two dosing methods, and neither the doctors nor the families will know which method is used to keep the results fair. This study will help doctors find the safest and simplest way to give spinal anesthesia to young children during certain surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 1-6 years
• • Both genders.
• • American Society of Anesthesiologists (ASA) physical status I or II.
• • Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
• Exclusion Criteria:
• • Guardian refusal.
• • Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention)
• • Children with neuromuscular disorders or high intracranial pressure.
• • Children with spinal deformities or morbid obesity (body mass index (BMI) above the 99th percentile).
• • Children with a history or family history of coagulation disorders.
• • Children with local infection at the site of skin puncture for spinal anesthesia.
• • Children with known allergy to Bupivacaine.
• • Surgeries requiring Trendelenburg or prone position.
• • Unexpected prolongation of surgery \> 90 minutes