NCT07385352

Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery

Comparative Evaluation of Caudal Dexmedetomidine and Caudal Ketamine as Adjuvants to Isobaric Bupivacaine for Postoperative Analgesia in Children Undergoing Surgery for Developmental Dysplasia of the Hip

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Developmental Dysplasia of the Hip

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.
DRUG	Ketamine	Ketamine 0.5 mg/kg added to caudal Bupivacaine.
DRUG	Bupivacaine	Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Egypt