Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery (CDK-DDH)

Assiut University

Status: Begins enrollment this month

Conditions: Developmental Dysplasia of the Hip

Treatments: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07385352

04-2026-201643

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia.

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine

Ketamine Group

Experimental group

Description:

Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia.

Treatment:

Drug: Ketamine

Drug: Bupivacaine