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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known allergy to local anesthetics, Dexmedetomidine, or Ketamine
• Coagulopathy or bleeding disorders
• Infection at the site of caudal injection
• Neurological disorders
• Severe systemic disease
• Refusal of parental consent

De-identified individual participant data (IPD) that underlie the results reported in this study will be shared upon reasonable request from qualified researchers. Data will include demographic data, intraoperative and postoperative analgesic parameters, pain scores, and adverse events, after removal of all personal identifiers.

Beginning 6 months following publication and ending 5 years after publication.

Access will be provided to researchers with a methodologically sound proposal, after approval by the principal investigator and institutional ethics committee. Data will be shared for purposes of achieving the aims of the approved proposal. A data access agreement will be required.

Double-blind study: neither the patient, the anesthesiologist administering the block, nor the assessor recording pain scores will be aware of group allocation.