“A Comparative Evaluation of two doses of Dexmedetomidine as an Adjuvant to Ropivacaine for Caudal Analgesia in Pediatric Infraumbilical Surgeries: A Randomized Controlled Trial”

This randomized, double-blind, controlled study will be conducted to evaluate the efficacy and safety of two different doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) when added to ropivacaine for caudal analgesia in pediatric patients undergoing elective infraumbilical surgeries. The primary objective will be to assess and compare the duration of postoperative analgesia, while secondary objectives will include To determine the requirement for rescue analgesia in the postoperative period, To evaluate and compare the hemodynamic stability (HR, BP) intraoperatively and postoperatively between the groups, To assess and compare the sedation level using a standardized sedation scale, To assess the incidence of adverse effects such as bradycardia, hypotension, respiratory depression, nausea, and vomiting, To evaluate and compare the incidence and severity of emergence agitation using a validated agitation scale, To assess parental satisfaction regarding postoperative pain management and recovery. The study will be carried out in the Department of Anesthesiology, BPS GMC Khanpur Kalan, over a 12-month period, enrolling a total of 90 children aged 1–8 years undergoing infra-umbilical surgeries. Patients who meet the inclusion criteria (ASA physical status I or II) will be randomly allocated into three equal groups of 30 each. Group C (Control) will receive 0.25% ropivacaine (1 ml/kg) with 0.5 ml of normal saline. Group LD (Low Dose) will receive ropivacaine with 0.5 µg/kg dexmedetomidine, and Group HD (High Dose) will receive ropivacaine with 1.0 µg/kg dexmedetomidine. Randomization will be performed using computer-generated numbers, and drug solutions will be prepared by an independent anesthesiologist to ensure blinding. After Pre-anesthetic evaluation patients will be counselled about the anesthetic procedure and received in pre-operative room on the morning of surgery after confirming NPO status, recording of vitals parameters and IV line will be established and Isolyte-P will be started using Holiday-Segar’s formula. Syrup Pedicloryl (Triclorfos) will be administered orally in a dose 50 mg/kg as pre-medication at least 45 min prior to surgery. On arrival in the operating theatre, baseline parameters such as heart rate, blood pressure, oxygen saturation, and respiratory rate will be recorded. Standard monitors will be applied, premedication will be administered with injection glycopyrrolate and injection fentanyl. Anesthesia will be induced using intravenous propofol, O2 and sevoflurane, maintained with a combination of oxygen, nitrous oxide, and sevoflurane. Atracurium may be used for muscle relaxation, if necessary. Airway will be secured with an appropriate-sized supraglottic airway device. The caudal block will be performed under all aseptic precautions using a 25G needle under ultrasound guidance. After administration of the block, the patient will be repositioned supine, and surgery will commence. Intraoperative monitoring will include ECG, pulse oximetry, capnography, and non-invasive blood pressure at 5-minute intervals. Any intraoperative events, including the need for additional analgesia, will be documented. In the postoperative period, patients will be monitored in the PACU (Post anesthesia care unit). Pain assessment will be conducted using the age appropriate FLACC scale (1-5 years age) and Wong Baker Faces scale (6-8 years age) at intervals of 30-minutes, 1, 2, 4, 6, 12, and 24-hours postoperatively. Sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Additional data including time to first rescue analgesia, total analgesic consumption within 1st 24-hours post-operatively and the presence of any side effects will be recorded.