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

January 27, 2026 updated by: Esraa Abdelmonem Ahmed Mahmoud, Assiut University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515
        • Assiut University Hospital
        • Contact:
        • Principal Investigator:
          • Esraa Abdelmonem, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dexmedetomidine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia.
Drug: Dexmedetomidine
Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.
Drug: Bupivacaine
Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
Experimental: Ketamine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia.
Drug: Bupivacaine
Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
Drug: Ketamine
Ketamine 0.5 mg/kg added to caudal Bupivacaine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
First 24 hours post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Intraoperative and first 24 hours post-surgery
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.
From caudal block to first request for rescue analgesia
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.
First 24 hours post-surgery
Rescue Analgesia Requirement
Time Frame: First 24 hours post-surgery
Number of patients requiring additional analgesia within the first 24 hours post-surgery.
First 24 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Esraa Abdelmonem, MSc, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-2026-201643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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