Protocol for a prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India

Abstract

Background Pediatric caudal anesthesia is a well-established technique for providing intraoperative and postoperative pain relief in children undergoing infraumbilical surgeries. Dexmedetomidine, an α2-adrenergic agonist, has shown promise as an adjuvant to local anesthetics in caudal blocks, potentially improving the quality and duration of pain relief. This study aims to compare two doses of dexmedetomidine with bupivacaine to assess their efficacy in pediatric caudal anesthesia. Methods A prospective comparative randomized clinical study will be conducted over two years in the Department of Anaesthesiology at Jawaharlal Nehru Medical College (JNMC) and Acharya Vinoba Bhave Rural Hospital (AVBRH) in Central India. Patients aged six months to six years, with American Society of Anesthesiologists (ASA) Class 1 or 2, scheduled for infraumbilical surgeries, will be included. They will be randomly allocated to receive either Group A (1 ml/kg of 0.25% bupivacaine with 1 μ/kg dexmedetomidine) or Group B (1 ml/kg of 0.25% bupivacaine with 0.5 μ/kg dexmedetomidine) in a double-masked fashion. The primary outcome is the duration of postoperative pain relief. Secondary outcomes include intraoperative hemodynamic stability, time first to rescue analgesia, incidence of adverse effects, and patient and parent satisfaction. A cost-effectiveness analysis will also be conducted. Conclusions The study will provide insights into the efficacy and safety of different doses of dexmedetomidine in pediatric caudal anesthesia for infraumbilical surgeries. The results will guide clinical practice and inform anesthesia protocols for pediatric patients in the study setting. Registration CTRI (CTRI/2023/05/057050; 29 August 2023).