Developmental Dysplasia of the HipCDK-DDHNCT07385352
Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery
A study testing Dexmedetomidine, Ketamine and Bupivacaine in people with Developmental Dysplasia of the Hip, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Dexmedetomidine, Ketamine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut, Asyut Governorate, 71515
Abdelmonem, MCs, +201116251563, Esraa.17289861@med.aun.edu.eg
Esraa Abdelmonem, MSc
About this study
Official 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
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.
Read the 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
- Being tested
- Dexmedetomidine, Ketamine, Bupivacaine
- Keywords
- Caudal block Dexmedetomidine Ketamine Pediatric analgesia Bupivacaine Postoperative pain Hip surgery DDH
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.
KetamineDrug
Ketamine 0.5 mg/kg added to caudal Bupivacaine.
BupivacaineDrug
Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia. Receives: Drug: Dexmedetomidine; Drug: Bupivacaine |
| Ketamine Group | Experimental | Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia. Receives: Drug: Ketamine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (FLACC)
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.
Measured: First 24 hours post-surgery
Secondary outcomes (4)
Hemodynamic Stability
Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants.
Measured: Intraoperative and first 24 hours post-surgery
Duration of 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.
Measured: From caudal block to first request for rescue analgesia
Adverse Effects
Recording any side effects related to caudal adjuvants, including bradycardia, hypotension, nausea, vomiting, and sedation, during the first 24 hours.
Measured: First 24 hours post-surgery
Rescue Analgesia Requirement
Number of patients requiring additional analgesia within the first 24 hours post-surgery.
Measured: First 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children are randomized to receive either Dexmedetomidine or Ketamine as adjuvant to caudal Bupivacaine for postoperative analgesia following developmental dysplasia of the hip (DDH) surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdelmonem Ahmed Mahmoud, Assiut University
- Investigators
- Esraa Abdelmonem, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385352
- Sponsor's protocol ID
- 04-2026-201643
- Acronym
- CDK-DDH
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Yoon JH, Park J, Conde J, Wakamiya M, Prakash L, Prakash S. Rev1 promotes replication through UV lesions in conjunction with DNA polymerases eta, iota, and kappa but not DNA polymerase zeta. Genes Dev. 2015 Dec 15;29(24):2588-602. doi: 10.1101/gad.272229.115.
PubMed 26680302Tait AR, Burke C, Voepel-Lewis T, Chiravuri D, Wagner D, Malviya S. Glycopyrrolate does not reduce the incidence of perioperative adverse events in children with upper respiratory tract infections. Anesth Analg. 2007 Feb;104(2):265-70. doi: 10.1213/01.ane.0000243333.96141.40.
PubMed 17242078Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
PubMed 15305253Beckie TM, Beckstead JW, Groer MW. The influence of cardiac rehabilitation on inflammation and metabolic syndrome in women with coronary heart disease. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):52-60. doi: 10.1097/JCN.0b013e3181b7e500.
PubMed 19935427Mokta KK, Kanga AK, Kaushal RK. Neonatal listeriosis: a case report from sub-Himalayas. Indian J Med Microbiol. 2010 Oct-Dec;28(4):385-7. doi: 10.4103/0255-0857.71824.
PubMed 20966576
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07385352
- Acronym / sponsor ID
- CDK-DDH / 04-2026-201643
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- Caudal block Dexmedetomidine Ketamine Pediatric analgesia Bupivacaine Postoperative pain Hip surgery DDH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Children are randomized to receive either Dexmedetomidine or Ketamine as adjuvant to caudal Bupivacaine for postoperative analgesia following developmental dysplasia of the hip (DDH) surgery.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine, Drug: BupivacaineChildren receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia. |
| Ketamine Group | Experimental | Drug: Ketamine, Drug: BupivacaineChildren receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Known allergy to local anesthetics, Dexmedetomidine, or Ketamine
- Coagulopathy or bleeding disorders
- Infection at the site of caudal injection
- Neurological disorders
- Severe systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine 1 µg/kg added to caudal Bupivacaine. | Drug | Dexmedetomidine Group |
| KetamineKetamine 0.5 mg/kg added to caudal Bupivacaine. | Drug | Ketamine Group |
| BupivacaineIsobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups. | Drug | Dexmedetomidine Group, Ketamine Group |
Primary outcome
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.
4 secondary outcomes
Hemodynamic Stability
Time frame: Intraoperative and first 24 hours post-surgery
Duration of Analgesia
Time frame: From caudal block to first request for rescue analgesia
Adverse Effects
Time frame: First 24 hours post-surgery
Rescue Analgesia Requirement
Time frame: First 24 hours post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 26680302Yoon JH, Park J, Conde J, Wakamiya M, Prakash L, Prakash S. Rev1 promotes replication through UV lesions in conjunction with DNA polymerases eta, iota, and kappa but not DNA polymerase zeta. Genes Dev. 2015 Dec 15;29(24):2588-602. doi: 10.1101/gad.272229.115.
- Background: PubMed 17242078Tait AR, Burke C, Voepel-Lewis T, Chiravuri D, Wagner D, Malviya S. Glycopyrrolate does not reduce the incidence of perioperative adverse events in children with upper respiratory tract infections. Anesth Analg. 2007 Feb;104(2):265-70. doi: 10.1213/01.ane.0000243333.96141.40.
- Background: PubMed 15305253Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
- Background: PubMed 19935427Beckie TM, Beckstead JW, Groer MW. The influence of cardiac rehabilitation on inflammation and metabolic syndrome in women with coronary heart disease. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):52-60. doi: 10.1097/JCN.0b013e3181b7e500.
- Background: PubMed 20966576Mokta KK, Kanga AK, Kaushal RK. Neonatal listeriosis: a case report from sub-Himalayas. Indian J Med Microbiol. 2010 Oct-Dec;28(4):385-7. doi: 10.4103/0255-0857.71824.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esraa Abdelmonem, MSc principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ketamine and Bupivacaine in people with Developmental Dysplasia of the Hip, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelmon (+201116251563, Esraa.17289861@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (FLACC) (time frame: First 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385352, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.