Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery

NCT07385352 | Not Yet Recruiting

• 1 other identifier: 04-2026-201643
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. The goal is to find the safest and most effective option for postoperative pain relief in children undergoing hip surgery.

Conditions

Developmental Dysplasia of the Hip

Keywords

Caudal block Dexmedetomidine Ketamine Pediatric analgesia Bupivacaine Postoperative pain Hip surgery DDH

Outcome Measures

Primary Outcomes (1)

• 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.

  First 24 hours post-surgery

Secondary Outcomes (4)

• Hemodynamic Stability

  Intraoperative and first 24 hours post-surgery

• Duration of Analgesia

  From caudal block to first request for rescue analgesia

• Adverse Effects

  First 24 hours post-surgery

• Rescue Analgesia Requirement

  First 24 hours post-surgery

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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

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.

Drug: Ketamine; Drug: Bupivacaine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.

Dexmedetomidine Group

Ketamine DRUG

Ketamine 0.5 mg/kg added to caudal Bupivacaine.

Ketamine Group

Bupivacaine DRUG

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

Dexmedetomidine Group; Ketamine Group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (5)

• 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.

  PMID: 26680302 BACKGROUND

• Tait 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.

  PMID: 17242078 BACKGROUND

• Zink 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.

  PMID: 15305253 BACKGROUND

• Beckie 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.

  PMID: 19935427 BACKGROUND

• Mokta 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.

  PMID: 20966576 BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Dexmedetomidine; Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Esraa Abdelmonem, MSc

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelmon

CONTACT

+201116251563; Esraa.17289861@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-blind study: neither the patient, the anesthesiologist administering the block, nor the assessor recording pain scores will be aware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Assiut University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months following publication and ending 5 years after publication.
• 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.

Locations

EG (1)