About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 1 to 6 years undergoing surgery for developmental dysplasia of the hip
ASA physical status I or II
Parental or guardian informed consent obtained
Disqualifiers
Known allergy to local anesthetics, Dexmedetomidine, or Ketamine
Coagulopathy or bleeding disorders
Infection at the site of caudal injection
Neurological disorders
Trial design
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugDexmedetomidine 1 µg/kg added to caudal Bupivacaine.
Ketamine
DrugKetamine 0.5 mg/kg added to caudal Bupivacaine.
Bupivacaine
DrugIsobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Hemodynamic Stability
Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants.
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.
Adverse Effects
Recording any side effects related to caudal adjuvants, including bradycardia, hypotension, nausea, vomiting, and sedation, during the first 24 hours.
Rescue Analgesia Requirement
Number of patients requiring additional analgesia within the first 24 hours post-surgery.
Sponsors and contacts
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