Developmental Dysplasia of the Hip
Conditions
Keywords
Caudal block Dexmedetomidine Ketamine Pediatric analgesia Bupivacaine Postoperative pain Hip surgery DDH
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.
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.
DRUGKetamine
Ketamine 0.5 mg/kg added to caudal Bupivacaine.
DRUGBupivacaine
Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Double-blind study: neither the patient, the anesthesiologist administering the block, nor the assessor recording pain scores will be aware of group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (FLACC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Stability | Intraoperative and first 24 hours post-surgery | Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants. |
| Duration of Analgesia | 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. |
| Adverse Effects | 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. |
| Rescue Analgesia Requirement | First 24 hours post-surgery | Number of patients requiring additional analgesia within the first 24 hours post-surgery. |
Countries
Egypt
Contacts
CONTACTAbdelmon
PRINCIPAL_INVESTIGATOREsraa Abdelmonem, MSc
Assiut University
Outcome results
None listed