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NCT Number: NCT07385352

Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery

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.

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Key information

Conditions

Developmental Dysplasia of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location contact

Abdelmonem, MCs

CONTACT

[email protected]

+201116251563

Esraa Abdelmonem, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.

ketamine

Drug

Ketamine 0.5 mg/kg added to caudal Bupivacaine.

Bupivacaine

Drug

Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.

Primary outcomes

  1. Postoperative Pain Score (FLACC)

    Time frame: First 24 hours post-surgery

    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

  1. Hemodynamic Stability

    Time frame: Intraoperative and first 24 hours post-surgery

    Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants.

  2. Duration of Analgesia

    Time frame: From caudal block to first request for rescue 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.

  3. Adverse Effects

    Time frame: First 24 hours post-surgery

    Recording any side effects related to caudal adjuvants, including bradycardia, hypotension, nausea, vomiting, and sedation, during the first 24 hours.

  4. Rescue Analgesia Requirement

    Time frame: First 24 hours post-surgery

    Number of patients requiring additional analgesia within the first 24 hours post-surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelmon

CONTACT

[email protected]

+201116251563

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: CDK-DDH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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