This study compares two medicines, Dexmedetomidine and Ketamine, added to caudal Bupivacaine to control pain after hip surgery in children. We will check how well each medicine reduces pain, how long the pain relief lasts, and if children need extra pain medicine. The goal is to find the safest and most effective option for postoperative pain relief in children undergoing hip surgery.
Background: Postoperative pain control is a major concern in pediatric patients undergoing surgery for developmental dysplasia of the hip (DDH). Caudal epidural block with Isobaric Bupivacaine is a common technique, but its duration of analgesia is limited. Adjuvants such as Dexmedetomidine and Ketamine may prolong analgesia and improve postoperative comfort. Objective: To compare the efficacy and safety of caudal Dexmedetomidine versus caudal Ketamine as adjuvants to Isobaric Bupivacaine for postoperative analgesia in children undergoing DDH surgery. Study Design: Randomized, double-blind, parallel-group clinical trial Participants: Pediatric patients scheduled for DDH corrective surgery Interventions: Group A: Caudal Bupivacaine + Dexmedetomidine Group B: Caudal Bupivacaine + Ketamine Outcomes: Primary: Postoperative pain scores using FLACC scale Secondary: Duration of analgesia, need for rescue analgesia, hemodynamic stability, and adverse effects Significance: This study aims to provide evidence for the most effective and safe adjuvant for pediatric caudal analgesia, reducing opioid use and improving postoperative comfort and recovery in children undergoing hip surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.
Ketamine 0.5 mg/kg added to caudal Bupivacaine.
Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
Assiut University Hospital
Asyut, Asyut Governorate, Egypt
Postoperative Pain Score (FLACC)
Pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at regular intervals (every 2-4 hours) during the first 24 hours after surgery to evaluate the effectiveness of caudal analgesia in children receiving Dexmedetomidine or Ketamine as adjuvants to Bupivacaine.
Time frame: First 24 hours post-surgery
Hemodynamic Stability
Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants.
Time frame: Intraoperative and first 24 hours post-surgery
Duration of Analgesia
Time from caudal block administration to first request for rescue analgesia, measured in hours, to compare the prolongation of analgesia between Dexmedetomidine and Ketamine groups.
Time frame: From caudal block to first request for rescue analgesia
Adverse Effects
Recording any side effects related to caudal adjuvants, including bradycardia, hypotension, nausea, vomiting, and sedation, during the first 24 hours.
Time frame: First 24 hours post-surgery
Rescue Analgesia Requirement
Number of patients requiring additional analgesia within the first 24 hours post-surgery.
Time frame: First 24 hours post-surgery
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